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Textile Progress
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Nonwoven Wound Dressings

N. Mao & S.J. Russell

Available online: 08 Jul 2010

To cite this article: N. Mao & S.J. Russell (2004): Nonwoven Wound Dressings, Textile Progress,
36:4, 1-57

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N. Mao and S.J. Russell


1.1 Definition of a Wound and Wound Healing
A wound is defined as a disruption of normal anatomic structure and function [1]. Wounds
can be classified according to their thickness, the involvement of skin or other tissues, the
time elapsed from the point of trauma (breaking of skin continuity), the wound morphology
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and the method of wound closure. Wounds are also classified in terms of how they heal, and
by the type of bacterial contamination [2]. In clinical practice, wounds are usually divided
into two types: acute and chronic. The terms ‘acute wound’, ‘chronic wound assessment’,
‘wound extent’, ‘wound burden’, and ‘wound severity’ and the guidelines for assessment of
wounds and the evaluation of healing have been reviewed by Lazarus et al. [1].
Examples of different wound categories include [3]:
(i) donor sites, grazes and abrasions;
(ii) incisions and puncture wounds;
(iii) deep wounds, where there is extensive loss of sub-epidermal tissue;
(iv) burns, caused by scalding, electricity, fire, chemicals, or irradiation; and
(v) pressure sores.
Wound healing is defined as a complex dynamic process that results in the restoration
of anatomic continuity and function [1] and it usually involves an orderly sequence of
biological events [4]. Wound healing may be referred to as first or second intention [5].
Wound dressings are a medical means of cleaning, covering and protecting wounds in order
to facilitate healing. Wound healing and the dressings employed rely on different approaches
including conventional wet-to-dry [5], modern moist wound healing [3] and bioengineered
skin replacement therapy [6], topical negative pressure therapy [7–9], heat therapy [10, 11],
oxygen therapy [12–14], enzyme therapy [15], maggot therapy [16, 17], and other therapies
[18]. In this review, we focus on dressings for moist wound healing.

1.2 Mechanism of Moist Wound Healing

When a wound is exposed to air, drying of the wound surface results in the formation of
a hard scab, which encourages regenerating epithelial cells to migrate under the dead
tissues towards the moist lower level before epidermal repair can take place [3]. In contrast,
‘moist wound healing’ as advocated by Winter [19] results in a shortening of the period of
healing, and less pain and scarring if infection is well controlled. Moist wound healing
allows experimentally induced wounds to resurface up to 40% faster than wounds exposed
to air [20].
The mechanism of moist wound healing has been extensively studied, and is described
in many books [4, 5, 21, 22]. Whitby [23] explained the developments in the biology of
wound healing and Steenfos [24] has summarised the function of growth factors in wound
2 Textile Progress

Winter [21] and Hinman and Maibach [25] proposed an explanation for the benefits of
moist wound healing using occlusive or semi-permeable occlusive dressings by suggesting
that epidermal migration is physically facilitated in moist conditions and in the absence of a
crust. Rovee [26] stressed that greater epidermal cell movement, rather than mitosis, is
responsible for the increased rate of epithelialisation of occluded wounds. Numerous
investigators have since confirmed the usefulness of various types of occlusive dressings in
human non-experimental acute wounds. Barnett et al. [27] concluded that split-thickness
skin-graft donor sites covered with polyurethane film dressings (specifically, OpSite or
Tegaderm) healed nearly twice as fast as those covered with a highly permeable fine-mesh
gauze dressing. Similarly, a positive experience with a poly(ethylene oxide) hydrogel dressing
(Vigilon) was reported by Mandy [28], in his studies of wounds made during the process of
hair transplantation and demarcation.
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Rapid development in the methods of wound healing is also attributed to advancements in

biology. Recent studies (mainly in vitro), with the development of growth factors [24], have
shown that these cytokines have an important role in wound healing [29–32]. An attractive
explanation of the faster epithelialisation under occlusive dressings (films, hydrocolliods or
hydrogel dressings) is that they keep wound fluid in contact with the wound, and certain
cytokines (probably growth factors) present in the wound fluid are thought to modulate
connective tissue formation and epidermal migration [33–35]. Cytokines such as interleukin
1, epidermal growth factor, platelet-derived growth factor and transforming growth factor-
beta are likely to be present at the wound site [24]. Interestingly, Buchan et al. [36] reported
that the gross chemical and immunoglobulin composition of fluid taken from acute wounds
occluded with OpSite is quite similar to that of serum. Ono et al. [37] examined the fluids
after five days under a film dressing, and reported that the fluids accumulated under the film
contained growth factors thought to promote healing. The fluids were rich in TGF-alpha
but contained no EGF or bFGF, which suggests that TGF-alpha plays a major part in
promoting local wound healing. Nemeth et al. [38] suggested that wound fluid from graft
donor sites accelerated epidermal outgrowth from split-thickness swine skin.
Other research on chronic wound healing has shown that the wound fluid present in
chronic wounds may, in vitro, either increase fibroblast proliferation [39] or enhance connec-
tive tissue synthesis [40]. This may also help to explain the mechanism of wound healing
under occlusive dressings.
Additionally, whereas Eaglstein [41] and other workers [42, 43] did not find an increased
frequency of any infection [44, 45] in occlusive wounds, the presence of large amounts of
fluid in occluded wounds raises concerns about infection. There is evidence that occluded
wounds (whether acute wounds [46] or chronic wounds [40]) accumulate a greater number of
micro-organisms than air-exposed wounds. Katz et al. [47] and Gores and Messner [48]
observed that occlusive dressings, including Duoderm, did not prevent clinical infection and
all the dressings provided microenvironments that were conducive to the growth of resident
and pathogenic bacteria.
However, in acute wound healing, it has been found that this increased bacterial coloni-
sation does not prevent occluded wounds from healing at the same rate as [47] or faster than
[20, 49] air-exposed wounds. In chronic wounds, Falanga [40] found occlusion to be safe
even with heavy bacterial colonisation. It is also reported that occlusive dressings, such as
OpSite [50] and Duoderm [5, 51], are able either to inhibit bacterial pathogens or to prevent
bacterial entry into wounds. Other benefits of occlusive dressings include painless
debridement [52, 53], the mechanism of which was studied by Falanga [40].
Nonwoven Wound Dressings 3

There are other possible explanations for the effectiveness of moist wound healing and the
function of occlusive dressings. One that has been suggested is the role of occlusion in
maintaining a normal voltage gradient lateral to the wound. Human skin has measurable
transcutaneous potential differences that are decreased by wounding, and there is evidence
that the maintenance of such electrical fields may be important to epidermal cell migration
[54]. It has been shown [55] that in vitro electrical stimulation leads to an increased
expression of receptors for growth factors by human dermal fibroblasts and subsequently to
a greater synthesis of collagen after the addition of the growth factor. Some researchers [40]
have suggested that a higher receptor number for growth factors available in wound fluid
might be a favourable effect of occlusion.
Eaglstein et al. [56], after examining the effect of delayed application and early removal
of a polyurethane dressing (Tegaderm) on epithelialisation, indicated that, from initial
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wounding to six hours later, the application of the dressing increases the rate of epitheliali-
sation. Moreover, after the first twenty-four hours, keeping the dressing on the wound was
not necessary to enhance epithelialisation.

Wound dressings are used to clean, cover and protect wounds in order to facilitate healing,
and nonwoven fabrics are increasingly important in this area.

2.1 Types of Wound Dressing

Dressings are categorised according to their application (e.g. cavity), medical performance,
structure (e.g. single layer, island, composite, sleeve), the materials used in their construction
[57] and their medical use [58, 59]. Commercial dressings can be classified into the following
groups according to their function [60].
Primary wound dressings are wound-contact materials (or layers) applied directly to
a wound to absorb exudates, provide protection from external contamination and
facilitate healing. They can be self-adhesive, or have low-adherent interface layers
between the wound and a secondary absorbent layer.
Dressing packs are sterile wound-care items, packaged together for use in changing a
dressing or carrying out a similar procedure.
Surgical absorbents are products for cleansing wounds or for secondary absorbent
layers to be applied over a primary dressing in the management of heavily exuding
Extensible dressings/Bandages: The bandages in the Drug Tariff may be classified into
groups according to their function and performance. These include surgical tapes, paste
bandages, tubular bandages and stockinettes.
Surgical dressings in The British Pharmacopoeia [61] are categorised as either:
(i) passive products, which protect and cover wounds, or
(ii) interactive products designed to create an optimum micro-environment for wound
healing, and bioactive products that deliver or stimulate delivery of substances
active in the healing process [61].
Passive products have limited use as primary dressings in modern wound management.
They often impair healing by drying out the wound and/or adhering to the wound surface,
4 Textile Progress

resulting in trauma when the dressing is removed. Such passive products include [62]:
conventional gauze (yarn-based products composed of viscose rayon, cotton or
paraffin tulle dressings, medicated and non-medicated;
non-paraffin, non-tulle, woven products, medicated and non-medicated;
non-adherent dressings; and
combinations of the above.
Bioactive and interactive wound dressings, which include antimicrobial materials, algi-
nates, hydrocolloids, materials containing collagen or other extracellular matrix components
(in particular hyaluronic acid), and skin-replacement materials, have been summarised by
Stewart [63]. Besides maintaining a moist wound environment, these dressings will also either
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interact with cells or matrix proteins in the wound bed or sustain the release of antimicrobial
agents (e.g. Iodosorb, Actisorb Silver 220, Acticoat 7) to promote wound healing.
Wounds have different characteristics, and these dictate specific design features in the
dressing. According to the interaction of fluid with the dressing in moist wound healing,
dressings may be divided into two main groups:
(i) absorbent, physically porous dressings, which allow free passage of exudate from the
surface, and
(ii) non-absorbent, liquid-impermeable, occlusive dressings, where the wound exudate is
retained at the wound bed.
Composite or laminated dressing structures are not included in these two categories.

2.1.1 Occlusive and Semi-occlusive Dressings

Falanga [40] has defined dressings that keep a wound moist and prevent crust formation as
occlusive or semi-occlusive dressings. Commercially, there are four basic types of occlusive
dressings [40, 64].
(i) Films [65] are typically thin, transparent and adherent polyurethane materials that
stick only to dry or non-wounded skin when placed on the site. Films are not
absorbent but permeable to moisture vapour and atmospheric gases and are both
waterproof and impermeable to bacteria. Films do not adhere to moist wounds.
Films are indicated for use on dry or slightly exudating superficial wounds, or as
a secondary dressing over primary dressings such as foams, hydrogels or alginate
nonwoven materials. The slippery surface can prevent unwanted pressure on wounds
resulting from friction and shear, particularly over areas such as the sacrum, heels,
elbows and other protrubruances.
(ii) Foams [66, 67] are generally made of non-adherent polyurethane materials that are
taped in place over the wound. They have reasonably high fluid-handling capacity and
therefore promote a moist wound environment without allowing maceration of the
skin. They are thermally insulating, permeable, non-adherent and non-toxic. They can
be used effectively under compression. Foams can be used on a wide range of wounds
including lightly to moderate or highly exudating superficial wounds. Silicone foam
may also be used as a cavity dressing. Foams are applied as secondary dressings over
amorphous hydrogels, hydrocolloid powders/pastes, cadexomer iodine and alginate
materials. It has been demonstrated [68] that epithelialisation occurs faster under
impermeable hydrocolloid materials than beneath a semi-permeable film dressing.
Nonwoven Wound Dressings 5

(iii) Hydrocolloid dressings [69]: Hydrocolloids [70] are hydrophilic polymers, of vegetable,
animal, microbial or synthetic origin, that generally contain many hydroxyl groups
and may be polyelectrolytes. Most important among their properties are viscosity
(including thickening and gelling) and water binding.
Hydrocolloid dressings [71] are multi-component structures and are sterile, self-
adhesive, waterproof and semi-permeable. The wound-contact layer is made from an
adhesive matrix containing a homogenous dispersion of a hydrophilic substance such
as carmellose sodium, gelatin, hydroxyethylcellulose, calcium alginate, chitosan or
pectin. The hydrocolloid matrix is applied in a uniform manner in a carrier which
may consist of a semi-permeable film or a polymeric foam layer or a combination of
both. The hydrophilic components of the dressing are opaque, gas-impermeable, and
absorbent and can take up wound exudate to form a gel. When applied to wounds,
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the accumulation of wound fluid causes a gradual separation of the dressing from the
wound. Hydrocolloids can be used on lightly to moderately exuding wounds such as
leg ulcers, pressure wounds, burns, donor sites, etc. [72]. Sometimes hydrocolloids do
not completely retain liquids, resulting in leakage of odorous exudate and wound
dressing gel [40].
(iv) Hydroactive dressings [73]: Hydroactive and hydrocolloid dressings are similar.
Hydrocolloid dressings form a gel whereas hydroactive dressings trap the fluid within
the matrix structure and swell when combined with wound exudates. Hydroactive
dressings mainly absorb the water from wound fluid and leave growth factors and
proteins in the wound [74]; they are usually non-adherent, waterproof and claimed to
be bacteria-proof. Hydroactive dressings are suitable for wounds with a moderate to
high level of exudate, such as minor burns, grazes and lacerations, pressure wounds
and leg ulcers.
(v) Hydrogel dressings [71]: Hydrogels are three-dimensional polymer chain networks
that swell, but do not dissolve, in water. They are commonly made of poly(ethylene
oxide) membranes or other polymers, and contain up to 95% water.
Hydrogel dressings, in general, are said to have a soothing effect on tissues and can
significantly reduce pain. They are able to donate moisture to dehydrated tissue and
absorb some moisture from an exuding wound. Hydrogels are available in two
forms, amorphous hydrogels and sheet hydrogels. Amorphous hydrogels are soft
formless gels that become less viscous as they absorb fluid. They are particularly
useful for rehydrating sloughy or necrotic tissue and enhancing autolytic debride-
ment. Sheet hydrogels are available as sheets of gel that swell when fluid is absorbed
but maintain their integrity. Sheet hydrogel dressings are non-particulate, non-toxic
and non-adherent, and are useful in the treatment and prevention of pressure
wounds because they can withstand significant friction and shear. As the absorbency
of hydrogels is limited, they are best used on low-exuding or dehydrated wounds
such as minor burns, grazes/lacerations, donor sites and pressure sores [71].
Each of the basic dressing materials mentioned above has a particular combination of
properties and none are suitable for universal use.
2.1.2 Limitations of Occlusive Dressings and Their Combination with
Absorbent Dressings
While occlusive dressings are useful in maintaining a moist wound-healing environment,
they have well-documented limitations. Because film and hydrocolloid dressings are
6 Textile Progress

aggressive adhesives, they can result in stripping of the skin around the wound margins upon
removal [75, 76]. Foams can stick to the wound bed if wound exudation is low or has
decreased while the dressing is in situ [77]. Hydrogels rely on secondary coverings for
maintaining them on the wound surface [78]. If the secondary covering is highly absorptive,
it may deplete the moisture in the hydrogel and dehydrate the wound bed. If an adhesive film
is applied over a hydrogel, the excess moisture accumulated around the wound margins can
cause maceration and wound deterioration.
When fluid accumulates below the surface, or leakage channels break the seal to the
external environment, bacterial proliferation is facilitated. Therefore, the accumulation of
large amounts of exudate from the wound is a problem associated with occlusive wound
The problem of excess wound fluid accumulation may be dealt with in two ways. Firstly,
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the fluid may be absorbed, but this can lead to increased adherence of the dressing, infection
and impaired healing. Secondly, water from the wound fluid may be allowed to evaporate.
Alper et al. [79] advocated aspirating the fluid from under the dressing, thereby avoiding
premature dressing removal. Semi-permeable polyurethane membrane films (e.g. OpSite,
Tegaderm and Pharma-Plast [80]) and foam (e.g. Lyofoam [81]) were introduced to be
permeable to water vapour and oxygen but impermeable to liquids. Removal of adherent
occlusive dressings risks stripping of the newly epithelialised surface [82]. However,
dehydration leading to increased adherence and impaired healing may result, and controlled
evaporation and the maintenance of a layer of fluid at the wound surface are not easy to
achieve. To overcome the build-up of exudate under conventional plastics film dressings on
heavily exuding wounds, nonwoven composite dressings have been developed in which the
exudate is transported, through a perforated film, into an absorbent nonwoven layer [5].
These apertured films are designed to be low-adherent owing to their surface morphologies.
Gel-forming or highly absorbent fibres can be incorporated into semi-occlusive nonwoven
dressings to overcome the problems associated with films. Such speciality fibres include
alginates, carboxymethylated cellulose, chitin and chitosan. On contact with exudate, the
wound-contact layer containing such fibres forms a gel, providing a moist wound-healing
environment and low adherence. In the case of calcium alginate fibre dressings, calcium ions
in the fibre exchange with sodium ions in the wound to form a sodium alginate gel above
the woundbed. Where such nonwoven contact layers are applied, vapour-permeable films
are commonly used to secure the secondary dressing. However, the weight of absorbed
exudate in the nonwoven dressing can pull the film away from the skin surface, loosening
the sealed edges.
Commercial dressings are frequently layered structures comprising different occlusive
materials and nonwoven absorbent pads. Such dressings usually comprise a hydrating layer,
which may contain antibiotic ointments or petroleum jelly, a non-adherent contact layer, an
absorbent, a cushioning nonwoven layer, and a securing layer made of tape or a wrap [83].
Interactive wound dressings or skin replacement products are also composite materials
with controlled porosity and defined biodegradability to control moisture loss and liquid
retention [84].

2.2 Historical Development of Wound Dressings

Wound dressings have existed for thousands of years and details of historical developments
in wound healing, wound-dressing materials and wound-care products are discussed by
Bishop [185], Elliot [85], Forrest [86] and Queen et al. [78].
Nonwoven Wound Dressings 7

2.2.1 Conventional Wound Dressings

A surgical dressing is traditionally applied to a wound to stem bleeding, to absorb exudates,
to ease pain, and to provide protection for the newly formed tissue [180]. Amongst the first
wound dressings were grease-soaked woven gauze bandages used by the Egyptians [87]. In
ancient times, a variety of unlikely substances were used for the purpose of dressing wounds,
including cobwebs, dung, leaves, animal fat, honey, and other exotic agents. Ironically,
many of these materials would have been heavily contaminated with micro-organisms,
making them a potential source of infection. Lint, which emerged in about the 1650s, and
cotton gauze, introduced by Sampson Gamgee, are still used today [3]. An important
milestone in wound-dressing development arrived in the late 19th century when the
importance of cleanliness and good aseptic practice was demonstrated in medicine and
surgery [3].
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Over the centuries, traditional wound dressings such as gauze gradually evolved into
more sophisticated structures, although their mode of operation and effect on wound healing
essentially remained unchanged. The dressings were non-occlusive and tended to dry out,
leading to adhesion of the dressing to the wound bed. Even if drying-out is incomplete,
capillary loops, associated with granulation tissue, can grow into the dressing structure [88],
resulting in dressing adherence. Such adherence creates wound trauma on removal of the
dressing, leading to bleeding and pain. Before the 1960s, gauze was widely used as an
absorbent dressing and was impregnated with paraffin wax to decrease adhesion to the
wound bed (tulle-gras). This type of low-adherent dressing was used to treat burns and
similar wounds [180].
Before the 1960s, one of the major functions of a wound dressing was to act as a barrier
between the wound and the outside environment to protect the site from gross microbial
contamination and to help prevent cross infection [40]. This ‘plug and conceal’ approach to
wound healing was also widespread where exuding wounds would be dried out by the
application of an absorbent dressing.

2.2.2 The Development of Modern Dressings for Moist Wound Healing

Although the benefits of moist wound healing were known to Hippocrates around 400 BC
[89] and were observed by a Swedish dermatologist in 1948 [90], they received little attention
until the late 1950s and early 1960s. Three key observations helped physicians think of
dressings as pharmacological agents. In 1958, Odland [141] observed that a blister healed
faster if left unbroken, and, in 1962, Winter [19] showed that, in superficial experimental
wounds in pigs (whose skin properties are thought to be the nearest to human skin), healing
was more rapid under an occlusive dressing composed of a polyethylene film than with
wounds exposed to air. Hinman and Maibach [25] established the beneficial effects of
occlusion on the resurfacing of experimental wounds in normal volunteers in 1963. Since
these early studies, extensive literature has been published supporting the idea that improved
healing occurs when superficial skin wounds are not allowed to desiccate [21]. Following
recognition of the benefits of moist wound healing in the 1960s, commercial moist wound-
care products began to be introduced in the 1970s [91]. Initially, these were based on
polyurethane films designed around Winter’s findings. Such dressings adhered to the
surrounding skin and maintained moisture within the wound environment.
Later, new types of wound dressing were developed, based on, for example, films, foams,
hydrogels, hydrocolliods and other occlusive materials [92]. Vapour-permeable, occlusive
and self-adhesive polyurethane foam dressings were amongst the first commercially available
8 Textile Progress

dressings to be produced [93]. The early occlusive film dressings provided some pain relief by
preventing dehydration of the wound surface and bathing the exposed nerve endings in
physiological wound secretions; however, the aggressive adhesiveness of these products was
reported to cause skin tears on removal [94]. The accumulation of excessive wound exudate
was also noted because of the low absorbency.
New approaches were therefore introduced to minimise wound trauma upon removal of
the dressing [95] and the accumulation of excessive fluid. Absorbent wound dressings were
developed including hydrocolloids [96], foams [97, 98], hydrogels [99, 100] and alginates
[101, 102]. The inherent water-vapour permeability of these dressings helped to prevent
maceration and decreased the possibility of infection by preventing the accumulation of
sweat and secretions [103] while providing a moist wound-healing environment. Composite
wound dressings comprising an absorbent pad and water-vapour-permeable materials to
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control the moisture content of the wound bed were also developed.
Hydrophobic silicone sheets and coatings that do not dry out when applied on top of a
wound-contact layer and maintain the non-adherence of the contact layer were designed
[104, 105] to deal with the problem of skin tears on removal of the dressing. Such dressings
were indicated for the treatment of burns [106], the resolution of hypertrophic scars [107]
and helping to minimise pain during removal [108]. These soft silicone dressings maintain
contact with the wound bed without friction and shear, thereby reducing the pain and the
tearing force during removal [109].
Recently, new hydrocolloids, foams and wound dressings containing highly absorbent
gelling fibres (e.g. hydrofibres) [110, 111] assembled into nonwoven fabrics have been
introduced and have improved fluid-handling properties. Such materials minimise adhesion
to the wound bed, increase the overall absorption capacity and permit painless dressing
removal [112, 113].

2.2.3 Development of Nonwoven Wound Dressing Components

The first nonwoven fabrics used in wound dressings emerged in the early 1950s as a
replacement for gauze and coincided with major advances in nonwoven web formation and
bonding technology [114]. At least initially, nonwovens were used as wipes in the wound-
care market, for cleaning, preparing and scrubbing of wound sites [114]. Because of the high
absorbent capacity, it was observed that fewer layers of nonwoven fabric were required to
construct a dressing having an absorbent capacity equal to or exceeding that of conventional
gauze. A four-ply nonwoven construct effectively replaced a twelve-ply or sixteen-ply gauze
sponge in most applications [115].
Compared with conventional woven gauze, nonwoven fabrics are claimed to provide
improved absorbent capacity, conformability, bulk, and softness and lower linting [115].
One significant advantage of nonwoven fabrics is their ability to manage fluid in three
dimensions where it may be necessary to distribute liquid uniformly, to transport liquid
faster in specific directions, or to impair liquid transport completely in specific directions.
Anisotropy of liquid absorption can therefore be a desirable feature in dressing fabrics
[116]. Nonwoven fabrics are inherently anisotropic in terms of liquid transport
characteristics and many experiments have demonstrated the anisotropy of liquid
absorption [117]. Mechanically bonded nonwovens generally contain no extraneous
chemical substances, assuming spin finishes are removed from the fibre. However, some
desirable wound dressing properties are traditionally difficult to obtain in nonwoven
materials. A common objection is that nonwoven fabrics do not conform and are not as
Nonwoven Wound Dressings 9

soft as woven fabrics. Certain process technologies, particularly hydroentanglement, enable

pseudo-gauze structures to be produced with apertures and three-dimensional, textural
effects. For years, hydroentangled fabrics made from viscose rayon or viscose rayon/
polyester blends have been integrated into wound-care products [114]. Scientists from
Johnson & Johnson helped to pioneer structured nonwoven fabrics by using profiled
forming surfaces, and more recently PGI’s Apex technology has enabled spunlaced fabrics
to be designed with complex structural patterning and three-dimensional features that are
visually analogous with woven and knitted fabrics. Such fabrics are claimed to enable
fluid uptake to be increased more rapidly and have higher absorptive capacity than
woven fabrics [118]. Furthermore, it has been argued that certain hydroentangled
fabrics of this type have better aesthetic and physical characteristics than traditional woven
gauze [118].
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Because of the flexibility of web formation processes [119], a large variety of speciality
fibres can be converted into nonwoven fabric and are increasingly found in tissue-engi-
neering matrices, including PET [120], PLA [121] and PGA [122, 123], PPDO/PLLA-b-PEG
[119], alginate [124], chitin and chitosan [125], fungal cellulose, carboxymethyl cellulose
fibres [126], hyaluronic acid derivative [127] and collagen [128].
Owing to the comparative performance benefits and the inherent versatility of manu-
facturing technology, nonwoven fabrics are increasingly incorporated into wound-care
products [129–131], where previously woven gauze would be selected. The functional attri-
butes and economic advantages of nonwoven wound dressings have been recognised by
both medical professionals and consumers [132–135]. In 1995, it was proposed that
standards for nonwoven fabrics intended for other medical and surgical uses should also be
considered for inclusion [132, 136] in The United States Pharmacopeia [137], in addition to
absorbent gauze.
A further area of development concerns electrospun nonwoven dressings [138], which
hold significant potential for producing nonwoven fabrics direct from solvated biomaterials.
With a fibre-diameter distribution from 3 nanometres to 3 micrometres, such dressings
provide interesting opportunities for protecting wounds from particulate contamination and
controlling permeability.

2.3 The Design Considerations for an Optimum Wound Dressing

2.3.1 Factors Influencing Wound Healing
To understand the function of a wound dressing and the requirements of an optimum
wound dressing, it is necessary to appreciate the factors that influence the wound-healing
process and therefore how the dressing can promote wound healing. The factors influencing
wound healing are covered in various books [3, 5, 25, 139], and influencing factors include
the humidity at the wound surface, the partial pressure of oxygen (PO2), the pH of the
wound fluid, and the functioning of cells [140] in the wound. In the design of wound dressing
structures, these factors are amongst the most important considerations. They are now
considered in turn. Control of Moisture Content In a dry skin wound it is possible for the dermis to
impede the movement of epidermal cells and prolong wound healing. In a moist wound bed,
wound healing is faster [19, 25, 40, 41, 141]. Leg ulcers and donor sites frequently produce
large volumes of exudate, and some burns have been shown to produce up to 5200 g m 2 day 1
[142] because of damage to the epidermis, which leads to dehydration of the tissue.
10 Textile Progress

In practice, microporous or hydrophilic breathable films may be used to simulate the

function of the epidermis, which is water-vapour permeable but impermeable to liquid water.
Whereas dehydration of wounds is generally considered to be disadvantageous, many
clinical problems are believed to be associated with copious or excessive accumulation of
wound exudate [143–147]. For example, the maceration of intact skin surrounding a chronic
wound is a common clinical problem [147]. In these situations, absorption of excessive
exudates may be the primary function of the wound dressing to prevent skin maceration and
wound infection [148]. In this case, the two important functions of a surgical or wound
dressing are the ability to absorb and hold liquid and the ability to wick and transfer
exudates of a wound away from the wound site, and certain well-designed nonwoven wound
dressings may be ideal to meet these requirements. Fletcher [149] and Bishop et al. [150]
discussed the importance of moisture balance at the wound–dressing interface in wound
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Control of the water-vapour transmission rate is one approach for influencing the
moisture content of the wound surface. Many researchers have studied the effect of water-
vapour transmission in wound healing [151, 152]. Lamke et al. [153] found that after thermal
injury the evaporative water loss from the wound surface can be twenty times greater than
that from normal skin. Queen et al. [154] tested in vitro the permeability characteristics of a
series of commercially available dressings by using a modified international standard
technique [155, 156] to assess the water-vapour transmittivity and predict the build-up of
wound exudate under film or the strike-through under foam. Pressure of Oxygen (PO2) and Gaseous Permeability In healing of wounds, the
effect of oxygen tension has been intensively studied and is controversial. A useful summary
is presented by Whitney [157]. Oxygen is thought to be involved in the following five
components of the healing process: hemostasis and inflammation, fibroblast proliferation,
angiogenesis, collagen synthesis and re-epithelialisation [158, 159].
One group of scientists suggests that high oxygen pressure promotes wound healing and
that application of oxygen can play a role in the prevention and control of wound infection
[160–162]. Silver [160] demonstrated that moist wound healing beneath permeable dressings
takes place more quickly in the presence of oxygen than under hypoxic conditions.
Horikoshi et al. [163] reported that epidermal cell growth in vitro is inhibited at oxygen
pressures that exceed that of ambient air [164].
It has been reported [165] that a hypoxic condition may rapidly be reached under
occlusive coverings and that this condition may encourage angiogenesis, negatively affecting
collagen synthesis and epithelialisation. In addition to minimising anaerobic flora by
discouraging germination, hypoxic conditions are known to reduce the concentration of
other pathogens as well [166].
Based on the belief that a sufficient oxygen level is needed to provide optimal healing,
oxygen-generating dressings [167, 168] and a combination of layered dressings having an
external low oxygen-permeability layer and an abutting internal oxygen-permeable layer
have been proposed [169]. A hyperbaric bandage [170] and a disposable hyperbaric
treatment bag with improved closure have been produced [171].
However, it is also claimed that reduced oxygen pressure promotes in vitro growth
of fibroblasts and production of angiogenesis factors from tissue macrophages
[172–174]. Because angiogenesis (the formation and growth of new blood vessels) is funda-
mental to the healing process and fibroblasts are associated with the production of new
Nonwoven Wound Dressings 11

tissue, Varghese et al. [175] suggested that a low rather than a high pressure of oxygen could
enhance the healing process.
It seems that there is little dispute about the effect of increased oxygen tension on the
improved healing of ulcers. It is believed that the increased oxygen tension in the wound
most likely results directly from increased diffusion into the wound surface from the exterior
oxygen supply [14].
Standard methods [176] are available to assess oxygen and carbon dioxide transmission,
and, by adopting a gas-to-liquid technique [177–179], the carbon dioxide transmission rate
in hydrogel dressings can be assessed. The British Pharmacopoeia also defines the testing
method for permeability and the water vapour transmission rate [61]. pH Effects In the blood, the release of oxygen from oxyhaemoglobin takes place
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most rapidly in an acid environment. During exercise, carbon dioxide and lactic acid build
up in the muscles, and the pH decreases, resulting in the maximum release of oxygen to meet
the needs of the body’s tissues. Conversely, an alkaline environment will tend to stablilise
oxyhaemoglobin and thus reduce the available oxygen [180]. Experimental results [175] have
indicated that wound fluid is more acidic under an impermeable hydrocolloid dressing (pH
6.1) than under an oxygen-permeable polyurethane dressing (pH 7.1), and bacterial growth
is retarded at an acidic pH similar to that found under hydrocolloid dressings. Infection Control Skin wounds tend to acquire pathogenic bacteria, due to the
increased water activity in serous exudates. The presence of dead tissue in burns and
particles shed from a dressing in the wound may lead to a wound infection [181].
One of the functions of a wound dressing is either to prevent or to remove bacteria from
wound sites to optimise re-epithelialisation rates, to reduce the incidence of wound sepsis and
to prevent cross-contamination [182]. Electrospun nonwoven wound dressings [138] have
been developed in recent years, which, owing to the small-diameter fibres ranging from several
nanometres to several micrometres, are thought to be useful in protecting wounds from
contamination. Another important function of a dressing is to remove debridement to
control wound infection [183]. Modern wound dressings such as hydrocolloids and other
occlusive dressings are found to be effective in reducing wound infections [184].
Dressings also provide vehicles for the delivery of phenol [185], chlorhexidine [186], silver
[187, 188], iodine [189, 190], zinc [191] and other antiseptics [192] to combat wound sepsis.
However, it has been argued that antiseptics have little influence on either the bacterial
content in wound sites or wound sepsis rates [193]. It is also claimed they are to some extent
toxic to skin [194]. Low Adherence Pain and tissue trauma are related to dressing changes [195]. Low
adherence to the wound bed is important for alleviating pain during such changes [196].
Non-absorbent, non-porous metal foil [197] and films have been used as non-adherent
wound dressings [198]. Nonwoven dressings containing hydrophobic fibres, such as
polypropylene [199] or EPTFE [200], with a controlled microscopic porosity, are claimed
to be non-adherent. Certain fibre finishes also help to minimise adherence in absorbent
wound dressings [201], and superabsorbent gelling materials, including hydrocolloids [202],
alginate [203], hydrofibre [204] and banana leaf dressings [205] are reported to be completely
non-adherent. The classification and management of skin tears using a soft silicone-coated
net dressing [206] that is non-adherent [207] have also been reported.
12 Textile Progress Effect of Growth Factors With rapid progress in the purification and cloning of
numerous growth factors, and the expanding understanding of the matrix proteins that
promote epidermal migration and growth [208], there is improved understanding of the
pathophysiology of diseases and of wound healing. Wound dressings incorporating growth
factors have therefore been developed [209].
Falanga [40] proposed the ‘growth dressing’ that combines occlusion with the timed or
pulsed delivery of specific growth factors designed to help a specific clinical problem. He
proposed the use of occlusion with an angiogenic growth factor to stimulate granulation
tissue, and then subsequently the use of an occlusive dressing that would deliver various
growth factors to speed up epithelialisation.
The application of growth factors in a gauze or beneath a watertight film or film chamber
has also been proposed [24]. Vehicles include the use of cream such as silver sulphadiazine
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that releases growth factor (GF) slowly for at least twelve hours when applied to wounds
[24]. Pluronic acid is a liquid at room temperature that becomes a gel at body temperature,
and is of interest together with collagen gels that dissolve over time and release growth
factors. Other approaches include the inclusion of growth factors in normal wound dressings
or in a polymer matrix to allow the production of active wound dressings [209] and
intelligent dressings incorporating therapeutic agents [210]. The intelligent dressing was
produced by a versatile branched pore-forming technique (VBPT) in which highly absorbent
areas take up wound exudate and these are interlaced with low-absorbing sites that release
therapeutic agents. The architecture and pore structure of nonwoven fabrics can be thought
to be similar in some respects to collagenous tissue, and nonwovens have been evaluated as
tissue-engineering matrices in recent years [211–213].
2.3.2 Requirements of an Optimum Wound Dressing
The function and properties of a nonwoven wound dressing are critically dependent on the
component fibre properties and the geometrical fabric construction. Both are available for
engineering purposes.
At present there is no universal wound-dressing design that is suitable to meet the
requirements of all clinical applications and, not surprisingly, the features of an ‘optimum’
wound dressing vary with the particular wound type. However, there are certain general
performance requirements if the healing rate is to be clinically acceptable and these have
been established over many years.
The functions of a wound dressing were first summarised by the surgeon Abraham Rees in
1819 [214]. Thereafter, various researchers have sought to summarise the basic requirements.
The desirable properties of wound-dressing materials were defined by Winter [21], Turner
[3, 215, 216] and other workers [23, 217, 218]. Turner [215] identified the performance
characteristics of an ideal wound dressing as ‘those factors which will produce a micro-
environment associated with the wound that will allow healing to proceed at the maximum
possible rate commensurate with the age and physiological condition of the patient’. In
1995, Whitby [23] proposed a more systemic list of requirements based on the biology of
wound healing as follows:
to maintain high humidity in the wound (epithelialisation proceeds more rapidly in a
moist environment);
to permit gaseous exchange; to maintain PO2 and pH at appropriate levels;
to maintain wound temperature close to body core temperature, allowing mitosis and
phagocytosis to proceed at optimal levels;
Nonwoven Wound Dressings 13

to aid removal of dead tissue and bacterial, chemical and physical contaminants (excess
wound exudate containing cellular debris increases the risk of bacterial infection, and
the presence of foreign material prolongs the inflammatory phase);
to be impermeable to bacteria; and
to be non-adherent, non-allergenic and free from contaminants (adherent dressings that
damage new epithelium when they are changed, and toxic and particulate contaminants
in the dressing that may prolong the inflammatory phase).
Walker [219] proposed that the requirements of a composite dressing should be:
to maintain high humidity at the wound/dressing surface;
to remove excess exudates;
to allow gaseous exchange;
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to provide thermal insulation and mechanical protection;

to be impermeable to bacteria;
to be free of particles and toxic wound contaminants; and
to allow removal without trauma.
Jones [220, 221] stated that the requirements of an optimum wound dressing included two
aspects: to promote wound healing by creating a moist wound environment and protecting
wounds and periwound skin, and to provide comfort for patients.
To engineer appropriate nonwoven wound dressings, it is important to understand how
fabric structure and properties relate to the requirements of an optimum wound-healing
environment. Relevant physical properties of a nonwoven fabric that can be readily
engineered include thermal resistance; liquid interactions (wettability, liquid penetration,
liquid retention, anisotropy of liquid transport, the absorption and retention of serum
albumin); gaseous permeability (air permeability and water-vapour transmission rate);
conformity; compression and elasticity; mechanical properties, adherence of the dressing
to the wound and surrounding skin; and chemistry of the constituent polymer (pH,
biocompatibility, toxicity, biodegradability).
Absorption of exudate by the dressing is designed to aid the removal of dead tissue
bacteria, as well as chemical and physical contaminants, so as to prevent wound infection,
which can prolong the inflammatory phase of the wound-healing process. An ‘ideal’ wound
dressing has many functional requirements and, for this reason, composite materials have
become important.
2.3.3 Design of Wound Dressings
Nonwoven dressings are claimed to provide controllable exudate-absorbing ability, are free
from chemical contaminants and have ideal thermal insulation [3]. Dressings comprising an
absorbent pad covered with nonwoven materials have been widely used [5]. A large number
of commercial wound-dressing products and patents have appeared that describe the use of
nonwoven structures and incorporate materials such as chitin, chitosan, alginate, collagen
fibre and superabsorbent fibres [222–226]. Some articles describe wound dressings
containing nonwovens [227] that both absorb and retain wound fluids in which the
absorbent material has a fluid transfer component.
In The British Pharmacopoeia, two examples of typical composite wound-dressing
structures containing nonwovens are described: plastics wound dressings (including imper-
meable plastics wound dressings [228], permeable plastics wound dressings [229], vapour-
permeable waterproof plastics wound dressings [230]) and perforated-film absorbent dressings
14 Textile Progress

[231]. Plastics wound dressings usually consist of two layers: an absorbent pad impregnated
with antiseptics and a plastics adhesive tape consisting of a film (impermeable, permeable or
waterproof and vapour-permeable, as required).
Perforated-film absorbent dressings usually consist of three layers [239]: the wound-facing
or contact layer, an absorbent middle layer and a backing layer. The three different types of
perforated-film absorbent dressing are summarised as follows. In Type I, the wound-facing
layer is a perforated film made of poly(ethylene terephthalate), the absorbent layer is a
porous nonwoven fabric made of bleached cotton fibre, viscose rayon fibres or a blend of
the two fibres with polyacrylonitrile. The backing layer is an apertured nonwoven cellulose
fabric. In Type II, the wound-facing layer is the same as in Type I, the absorbent middle
layer is a bleached cotton nonwoven fabric, and the backing layer is identical to the
wound-facing layer. In Type III, the outer layer (wound-facing layer and backing layer) is a
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sleeve consisting of perforated film made of poly(ethyl methyl acrylate). The sleeve forms
the wound-facing layer on the side without the join and the backing layer on the side
with the join. The absorbent middle layer is made of bleached cotton or viscose, or a
blend of both, sandwiched between two layers of an apertured nonwoven cellulose fabric.
This structure is very similar to the five-layer wound dressing that has been described
by Walker [219].
An example of a commercial perforated-film absorbent dressing is EXU-DRY (Smith &
Nephew) [232]. EXU-DRY is designed to cover the wound with reduced friction, save
nursing time and lower total dressing costs. It is claimed to protect the wound, support
healing, reduce friction and shearing and wick away drainage, and to be non-adherent,
non-occlusive, highly absorbent, and lint-free. The structure consists of:
an outer layer consisting of high-density-polyethylene film,
an inner layer of a highly absorbent viscose/cellulose blend nonwoven,
an anti-shear layer composed of high-density-polyethylene film, and
a wound-contact layer composed of high-density-polyethylene film. Liquid Absorbency and Liquid Transport The following requirements of an

‘optimum’ wound dressing are influenced by the liquid-transport properties of the
fabric [23].
Maintain a high humidity in the wound.
Be non-adherent, non-allergenic and free from contaminants.
Aid removal of dead tissue and bacteria, chemical and physical contaminants.
Be comfortable.
Maintain wound temperature close to body core temperature.
Specific applications for liquid transport in nonwoven fabrics relevant to wound-dressing
functionality may be summarised as follows [219].
Layers for liquid transmission, wicking and low adherence.
Wound-contact layers that can interact with the wound to form a gel.
Padding layers (absorbency, superabsorbency; thermal/mechanical insulation and
Barrier layers (prevention of liquid/bacterial strike-through).
Carrier layers for other materials (superabsorbent powders, activated carbon, anti-
microbials, adhesive, microspheres).
Nonwoven Wound Dressings 15

Many current wound dressings containing nonwoven fabrics are laminate structures
containing up to four elements:
(i) non-adherent or ‘gelling’ wound-contact layer;
(ii) wicking/transmission layer (cushions, protects and insulates);
(iii) diffusion layer; and
(iv) backing layer (bacterial barrier and moisture-vapour/gas-permeable film).
It is clear that nonwoven materials, as defined by various workers [180, 219], must be
combined with other fabric structures to perform as an ‘ideal’ wound dressing. Moist
wound healing can be obtained by maintaining high humidity at the wound surface using
moisture-vapour-permeable film backing layers [65, 229–231] or a gelling wound-contact
layer (perforated film, foam, calcium and sodium alginate fibres, hydrocolloids, hydrogels
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and hydrofibres [223]). Excessive exudate may be removed from the wound surface by an
absorptive nonwoven material and may be enhanced by the use of a wicking or diffusion
layer, which may be a nonwoven fabric [231] or paper. Maintaining the temperature of
the wound surface and mechanical protection of the wound from external agencies can be
achieved by selection of appropriate absorptive nonwoven fabrics and backing materials.
The removal of dressings without trauma requires low-adherent materials and struc-
tures [180]. Wounds covered with gel-forming polymers can be gently irrigated to clear
any residues on removal. Dressings made from biodegradable materials can reduce
the trauma upon removal significantly because the frequency of dressing changes is
Although moist wound healing requires the wound dressing to have the capability to
retain the wound surface at a high humidity level, the absorption of excess fluid in the form
of exudate is also fundamental. Many researchers have examined the clinical problems
associated with copious or excessive wound exudate [234–237], and the maceration of the
intact skin surrounding a chronic wound is a common clinical problem [238]. The removal of
exudate avoids tissue sloughing, and exotoxins or cell debris, which may retard growth or
extend the inflammatory phase, are also removed along with the excess exudates [3]. The
balance of humidity and liquid absorption is critical and, because of this, excessive wicking
must be avoided to prevent drying of the wound surface. This may be adjusted by
controlling the absorbency, the moisture vapour transmission rate of the dressing
components and the hydrophobicity of the different layers.
Traditional absorbent dressings based on gauze and similar textile materials are designed
to dry out the wound surface but, despite this, they remain the most commonly used wound-
dressing material. Basic gauzes are effective in removing blood and exudate from the wound
but they all, to a lesser or greater extent, adhere to the wound surface and may cause
considerable pain on removal. Low Adherence The need for absorbency is very important but it must be
achieved while maintaining low adherence. An early attempt to produce a non-adherent
dressing involved impregnating gauze with paraffin cream, poly(ethylene glycol) or aluminium
stearate, but this was not entirely successful. Low adherence for nonwoven absorbent
dressings may be achieved [239] by various means, including:
preventing dehydration of the exudate;
reducing absorption of fluids into the interior of the dressing; and
treating the dressing surface to render it non-adherent.
16 Textile Progress

Absorbent nonwoven dressings may be composed of non-absorbent fibres (polyester and

polypropylene) or absorbent fibres (bleached cotton, viscose, polysaccharides). Examples of
commercially available absorbent dressings are: Soffban Natural (viscose), Soffban Synthetic
(polyester), and Lantor Synthetic (polyester). Protection from Bacterial Contamination Microporous or hydrophilic films

used as a backing layer in a nonwoven dressing can assist in controlling bacterial perme-
ability and prevent particle and toxic contaminant penetration. One of the transport
mechanisms for bacteria to migrate into a wound dressing towards the wound site requires
strike-through of either wound exduate or some other liquid (e.g. saline solution) from the
back or edge of the dressing. Nonwoven fabrics can be designed to resist this strike-through;
however, the most effective barriers are impermeable or moisture vapour and gas semi-
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permeable films [65, 229–231]. The oxygen pressure and gaseous exchange through the
dressing, which are believed to influence wound healing, are also affected by the choice of
backing layer [65, 66, 69, 229–231]. Composite Wound Dressings for Better Wound Healing To avoid the problems
associated with traditional dry absorbent dressings and the disadvantages of occlusive
dressings, laminated dressings have been designed. In The British Pharmacopoeia, for
example, four kinds of composite plastics wound dressing are defined:
(i) impermeable plastics wound dressings [228];
(ii) permeable plastics wound dressings [229];
(iii) vapour-permeable waterproof plastics wound dressings [230]; and
(iv) perforated-film absorbent dressings [231].
All of the above consist of at least two layers: an absorbent pad, which is usually a
nonwoven impregnated with antiseptics, and a plastics adhesive tape, which is made from a
film that is impermeable, permeable, waterproof, or vapour-permeable.
One example is a composite dressing comprising an apertured wound-contact layer that
allows exudate to pass freely into the absorbent layer but separates the absorbent layer from
the wound surface [240]. A composite absorbent dressing comprising polyurethane foam has
also been developed using a standard wound model [93].
Other examples are composed of an absorbent nonwoven fabric covered with a perforated
film. The film reduces the amount of absorbed exudate, leaving moist gel at the wound surface.
Therefore, adherence to the wound causing trauma on removal is minimised. However, it
is known that columns of dried exudate, which form in the film pores, can effectively connect
the wound surface to the dressing. Consequently, tissue damage is caused when the dressing
is removed [241]. There is increasing interest in exploiting a variety of new natural bio-
compatible materials in wound dressings because of the disadvantages of traditional yarn-
based gauze and the desire to design an ‘optimum’ wound-dressing structure.


3.1 Raw Materials
It is technically feasible for a variety of polymer materials to be utilised in the construction
of wound-dressing fabrics, provided they are not in direct contact with the wound. If applied
as a wound-contact layer or as a matrix for tissue-engineering, and interaction with cells,
blood and human body fluids is involved, there are specific physiological, biomedical, and
Nonwoven Wound Dressings 17

biocompatible requirements for such materials. The requirements of biomaterials intended

for implantation are summarised as follows [242]:
(i) they can be reproducibly obtained as a pure material without containing impurities
such as unintentional additives, unreacted monomers, low molecular weight
polymer, solvents, dust, metal contamination, lubricants, and plasticisers;
(ii) they can be fabricated into the design form without being degraded or adversely
changed; examples of such polymers include polyethylene, polypropylene and
(iii) they have the necessary chemical, physical, and mechanical properties (e.g. tensile
properties, solubility, hydrophobicity, water absorption and permeation) for
performing the required function; and
(iv) they must not induce thrombosis or interfere with the normal clotting mechanism,
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must not alter the configuration of stability of any cellular or soluble materials in
blood, must not induce any adverse inflammatory or foreign body reaction, and
must not be carcinogenic.

3.1.1 Conventional Fibres

Conventional fibres are based on both natural and synthetic polymers. Fibres based on
regenerated natural polymers have advantages over synthetic fibres as wound-contact layers,
as they contain no free monomers or the chemical additives used in synthetic-polymer
processing. The presence of fibre finish or residual finish is an issue for all man-made fibres
used in wound dressings. Cotton Cotton is a natural absorbent cellulosic fibre, which has long been used in
gauze and surgical swabs. Traditionally, for wound dressings or healthcare products, cotton
must be scoured and bleached to remove chemical impurities and wax. Scouring and bleaching
increase the absorbent capacity, optical whiteness and chemical purity. A typical cotton
scouring and bleaching process is shown in Fig. 1.
Cotton is readily converted into drylaid webs and batts that can be needlepunched,
hydroentangled, chemical-bonded, thermal-bonded or stitch-bonded. Cotton fibre specifi-
cations for drylaid hygiene products are given in Table 1 [243]. Additional requirements for
purified cotton fibre are shown in Table 2 [243].
Because cotton is biodegradable, it is still applied in composite wound dressings as an
absorbent. Examples include US P 6 155 083 [244], 6 653 520 [245], and 6 599 523 [246].

Fig. 1 Scouring and bleaching of cotton fibres [243]

18 Textile Progress

Table 1
Bleached Cotton Properties for Nonwoven Roll Goods*
Micronaire: greater than or ¼ 4.9
Length: greater than or ¼ 0.95 inch
Uniformity: greater than or ¼ 81.0%
Strength: greater than or ¼ 23.0 gf/tex
Non-lint content 0.8% maximum (MDTA-3)
Fibre-to-fibre cohesion, 1700 gf maximum (ICI Fibres Cohesion Test)
Fibre openness Equal to 100 cm3/g minimum (ITT Test Method)
From ref. [243].

Table 2
US Pharmacopeia Requirements for Purified Cotton*
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Test Specifications
Absorbency sinking time 10 s max.
Water retention from sinking test 24 times orig. wt.
Ash residue 0.2% max.
Water extract 0.35% max.
Ether extract 0.70% max.
From ref. [243].

However, it is seldom used in 100% form because of the related problems of linting
and sticking to the wound. Carboxymethyl cellulose and other cellulose derivatives are
increasingly common to reduce the adhesion of the contact layer to the wound. Regenerated Cellulose Fibres Viscose is a common wound-dressing absorbent.

Like cotton, it has the advantage of comparatively high absorptive capacity and retains
exudate to render the wound relatively dry without adhering to the neo-epithelium
e.g. Soffban Natural (viscose) [247]. Cellulose and cotton are usually utilised in surgical
swabs and absorbent cores, which are sterilised for surgical use. Viscose can provide a vehicle
for continuous delivery or the sustained release of actives such as chlorhexidine [248] to a
wound site, and it can be made non-adherent [249]. Bacterial cellulose, which can be
formed as nanofibres [250], provides excellent hydrophilicity, low air permeability and
high tensile index and has been considered as a biomaterial suitable for wound healing.
Bacterial cellulose also acts as a natural binder in nonwoven dressings, replacing synthetic
latex binders [251]. Bacterial cellulose is formed in static, shaken or agitated culture. In
static culture, it is produced in pellicle sheet form. In shaken and agitated cultures, fibres
of nanometre size are produced. Micro-organisms of the genus acetobacter Xylinum, which
are genetically adapted to be good cellulose producers under agitated conditions, are
preferred. From 1 to 30% of the bacterial cellulose may be added to water slurry of other
sheet-forming fibres as a binder component. A microbial-derived cellulose hydrogel wound
dressing has also been described for the treatment of chronic wounds and burns [252].
A surgical dressing for either preventing blood from exiting a wound or absorbing other
body fluids has been described [253], where the absorbent component is formed from a
multitude of randomly oriented cellulosic fibres in tissue or nonwoven form. The absorbent
fibres are elastically stressed and bonded by hydrogen bonds.
Oxidised cellulose (OC) has been considered for use as a wound-contact layer [254] and
bacterial cellulose fibres have been formed into artificial blood vessels [255] for use in
microsurgery and bioengineered wound dressings [256].
Nonwoven Wound Dressings 19 Keratin Fibres Keratin fibres, including human hair, wool and silk, are naturally-
occurring polyamides. The disulphide bonds in human hair [257] can be partially oxidised to
sulphonic acid residues, which are then reacted with a cation, to make a hydratable form
of keratin that is suitable as an absorbent wound dressing. Few examples of wool and silk
wound-contact layers have been reported, although wound dressings composed of
regenerated silk fibres are known [258]. Removal of the wool cuticle increases hydrophilicity
and a wound dressing composed of wool fibres with cuticular modification has been
proposed [259]. It has been suggested that hydrophilic wool fibres can form a suitable liquid-
permeable layer in absorbent wound dressings [260]. The chemistry of wool provides a basis
for its conversion into keratin membranes, films, foams, powders, hydrogels and fibrous
structures for potential uses in skin substitutes or implant matrices. Because of its high
cysteine content (c. 12–17% by weight), wool keratin has been proposed as an activated
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protein for use in wound dressings [261]. It has been suggested that the activated protein
could be attached to the skin by the formation of disulphide bonds in order to moisturise
and provide a vehicle to carry other agents into the dehydrated skin. Polyester Fibres Polyester is composed of at least 85% by weight of an ester of a

dihydric alcohol (HOROH) and terephthalic acid (p-HOOC-C6H4COOH) [262]. The most
widely used polyester fibre is made from the linear polymer poly(ethylene terephtalate), or
PET. The inherent hydrophobicity, high resilience, compression recovery and modulus are
the principal properties exploited in dressings. Polyester dressings consist of drylaid thermal
and mechanically bonded fabrics (where the porosity is over 90%) or vapour-permeable
meltblown and spunbond covers. Polyolefin Fibres The inherent hydrophobicity of polypropylene is useful in

wound-dressing design. It is applied in drylaid high-porosity fabrics as well as spunbond
permeable covers. Another advantage of polypropylene is that it is generally inert in the
presence of body fluids and chemical substances that degrade other fibres. The features of
non-adherent polypropylene dressings have been reported [263]. The hydrophobicity of
polyolefin fibres can be modified to increase hydrophilicity [264] as well as antibacterial
[264], antimicrobial, non-irritating and non-sensitising [265] properties. Another important
property of polyolefin fibres in dressings is their compatibility with thermal bonding [260] as
these polymers have a comparatively low melting temperature.

3.1.2 Speciality Fibres

Speciality fibres tend to have functionality that is not available in traditional materials such
as enhanced biocompatibility, superabsorbency or a predictable rate of biodegradability.
Many biodegradable polymer materials have been evaluated in nonwoven form. Such fibres
made from natural polymers and their derivatives include:
(i) polysaccharides, for example, starch from potatoes and corn, cellulose, alginate and
chitosan or chitin from marine crustaceans;
(ii) proteins such as gelatin (collagen), casein (from milk), keratin (from silk and wool)
and zein (from corn); and
(iii) polymers made from polyalkylene esters, polylactic acid, polyamide esters, polyvinyl
esters, polyvinyl acetate, polyvinyl alcohol, and polyanhydrides.
However, since the suitability of polymer materials for medical applications also depends
on biocompatibility with the human body, the principal speciality fibres associated with
20 Textile Progress

wound care are alginates, chitin, chitosan, collagen, fungal cellulose, carboxymethylated
cellulose (CMC), polylactic acid (PLA), polyglycolic acid (PGA), fibronectin, hylaronic acid
and fibres made from other biodegradable polymeric materials. These fibres tend to have
comparatively poor tensile properties and are therefore difficult to form into fabrics other
than by nonwoven processes. Chitin and Chitosan Fibres Chitin is estimated to be the second most abundant
polysaccharide in nature, with a synthesis of around one billion tons a year by marine
organisms [266]. It exists in the cell walls of fungi and the hard shell of insects and
crustaceans; the waste from shrimp, lobster and crab seafood industries contains 10–15%
Chitin is a polysaccharide comprising poly(N-acetyl-D-glycoamine) of relatively high
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molecular weight. Since chitin contains one aminoacetyl group per recurring unit, it can be
absorbed in the tissue after undergoing enzymatic decomposition in vivo; the biocompat-
ibility of chitin is especially important for wound dressings as well as other medical products.
However, in the natural state chitin exists only as short fibrous material, e.g. from the
carapace or tendons of crustaceans. Therefore, efforts have been made to form chitin into
longer fibres. The development of chitin fibres is described in various sources [267–270]. In
the early development [271], chitin films and fibres were formed by preparing a solution in
aqueous acids, and then spinning or casting, followed by coagulation with a non-solvent.
After the filaments were dried under tension, their tensile strength was quite low. Drawn
filaments extruded from lithium thiocyanate have also been reported in an effort to develop
molecular orientation [272], but an X-ray pattern of a chitin sheet reprecipitated from
lithium thiocyanate solution and supported on a glass plate showed only the broad diffuse
nodes of a strained, non-crystalline material.
Early US patents [273–275] describe the preparation of chitin xanthate for regenerating
chitin (or chitin-cellulose) films and fibres. These patents mention the stretching of filaments
in the gel state to improve physical properties, but not the drawing of solid chitin, required
for orientation. A xanthate process used to spin chitin fibres [276], which is analogous
to the spinning of cellulose to form rayon, was also described; the resultant 50:50
chitin:cellulose fibre was reported to be of 12.3 denier and have a tenacity of 1.08 gf/denier
(dry) and 0.13 gf/denier (wet).
A chitin derivative, dibutyryl chitin, was spun into fibres by a research group at the
University of Leeds. Dibutyryl chitin was prepared by treatment of krill chitin with butyric
anhydride in the presence of perchloric acid as a catalyst in a reaction carried out at
25–30 8C. Polymer samples with molecular weights high enough to form fibres were obtained
and dibutyryl chitin fibres were made by a simple method of dry spinning a 20–22% solution
in acetone. Chitin fibres with good tensile properties produced in this way by alkaline
hydrolysis of dibutyryl chitin fibres without destroying the fibre structure were claimed.
Bechitin is a commercial chitin-based nonwoven dressing, which has found clinical
acceptance. Although relatively few commercial dressings based on chitin or chitosan fibres
have become available, there has been considerable development of chitin nonwoven
dressings [277].
The British Textile Technology Group (BTTG) described a procedure for making fibrous
dressings based on chitin or chitosan fibres produced from fungi rather than from shrimp.
Because this method uses a non-animal source as the raw material, the resulting micro-
fungal fibres are different from normal extruded chitin fibres. They have highly branched,
Nonwoven Wound Dressings 21

Table 3
Properties of Chitin Fibres
Tensile Strength (kgf/mm2) Reference
Fibre Natural chitin 58 Clark and Smith [272]
Regenerated chitin 35 Kunike [271]
Regenerated chitin 63 Austin et al. [268]
Silk 35.6 Clark and Smith [272]
Viscose rayon 25 Kunike [271]
Wool 14.5 Clark and Smith [272]
Film Regenerated chitin (6.3*103 1bf/in2) Joffe and Hepburn [283]
Regenerated chitin 9.49 (dry), 1.75 (wet) Thor and Henderson [284]
Regenerated celullose 9.10 (dry)

irregular structures, which can form a three-dimensional matrix. Unfortunately, the fibres
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tend to be brittle when allowed to dry and a plasticiser has to be used. The fibres are
converted into a nonwoven dressing fabric by wet-laying [278]. A wet-laid nonwoven fabric
has been produced composed of chitin fibres of 30-mm length and 150-mm diameter [279]. In
a Japanese patent [280], chitin fibres of 1–5 den and 1-gf/den fibre strength were combined
with a chitin dope to act as a binder to form a nonwoven fabric. The nonwoven fabric
described in another source [281] was composed of 3-den (and ,10-den maximum) chitin
fibres without a binder. Nonwoven wound dressings containing very fine chitin fibres are
described elsewhere [282]. The dressing was composed of chitin fibres having a linear density
of less than 1 den and a strength of not less than 2 gf/den. A summary of the properties of
chitin fibres from various studies is given in Table 3. Values for other fibres are given for the
purpose of comparison.
Chitin fibres are claimed to have high tensile strength, flexibility and good absorption
properties [267]. Other attractive properties of chitin and chitosan include biocompatibility,
bio-absorbability and high absorbency. Prudden et al. [285] claimed that chitin containing
n-acetyl glucosamine is useful in accelerating wound-healing. Alginate Fibres Alginate polymers [286] and the fibres produced from them are
derived from brown seaweed (Phaeophyceae, mainly Laminaria), and those used for wound
dressings are preferably from Laminaria hyperborea or any other suitable source. Alginates
are linear unbranched polymers containing b-(1!4)-linked D-mannuronic acid (M) and
a-(1!4)-linked L-guluronic acid (G) residues. The ratio of guluronate/mannuronate
residues in alginate determines the solubility of alginate in water. It is recommended that
the ratio ranges from 1.5:1 to 2.5:1, preferably from 1.75:1 to 2.4:1, and may be about 2:1 or
2.3:1 [287]. Alginate-containing mannuronic and guluronic acid units in a mannuronic
acid:guluronic acid ratio in the range from about 55:45 to about 75:25 were proposed in a
US patent [288].
Alginate is favoured in dressings because it is bioresorbable and does not shed large
quantities of hydrocolloid material into the wound. Alginate also has good absorbency and
this is one reason why it is extensively used in the management of heavily exuding wounds
such as ulcers. Through a process of ion exchange, alginate dressings can donate calcium
ions to the wound, positively affecting haemostatic properties [289]. Normally, calcium
alginate is a solid but, in contact with wound fluid (or alkaline solutions), the ionic exchange
leads to a sodium alginate gel, which is usually soluble. In addition, calcium ions released
during the process of ionic exchange stimulate platelet aggregation and coagulation and thus
play a role in haemostasis. The conversion of alginate into a hydrogel when in contact with
22 Textile Progress

wound exudates promotes low adherence to the wound bed and a moist healing
environment, both of which are desirable. It is widely used to control haemorrhage, to fill
‘dead space’ after the removal of organs or massive tissue, to act as tissue-isolating films, and
externally as burn, ulcer and wound-dressing covers. Alginates are suitable for use in
moderate to highly exudating wounds and are useful for the treatment of acute traumatic
wounds that are bleeding heavily.
Alginate is formed into fibres using established production techniques such as wet-
spinning. Commercial alginate fibres used in nonwovens consist of calcium and sodium salts
of alginic acid. Alginate fibres for medical purposes are made from alginic acid with different
cations, e.g. sodium, calcium, zinc, silver, ammonium, magnesium, hydrogen ions [290] and
mixtures of them [291–296]. The preferred first cation is calcium, which is believed to have a
haemostatic effect on wounds. Zinc is also believed to be effective in the control of bacteria
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and disease. The use of alginate for the deliveries of antimicrobials, notably silver ions, has
been reported [297]. Sodium, potassium, lithium, ammonium, and magnesium alginates are
readily soluble. Alginate can also be incorporated with one or more pharmaceuticals such as
local anaesthetics or novocain, as well as antibacterial or antifungal agents, for use in
dressings. Many patents have been published on the extrusion of alginate solutions into
an aqueous solution containing calcium ions to form yarns of calcium alginate filaments
Films and filaments of alginic acid can be produced by preparing an aqueous solution of
alkali-metal alginate (using ammonia and alkali hydroxides or carbonates as solvents) whose
concentration does not exceed 10% expressed as alginic acid [298]. The solution is still acid,
neutral or only weakly alkaline and is transformed into a solid film by drying for 15
minutes or formed into a solid filament by spinning the acid solution flow into an aqueous
solution containing calcium ions. The proportion of ammonium alginate is not more than
85% of the total alkali present in the alkali-metal/ammonium alginate solution. Sterilisation
can be effected by heating the solution to 100 8C, or by incorporating a germicide with the
solution, for example, one part in ten thousand of copper ions.
Calcium alginate filaments can also be prepared by extruding a 5–10% aqueous solution
of sodium alginate into an aqueous solution containing 5–35 g/L of calcium chloride (or an
equivalent amount of any other calcium salt) [303]. It is also claimed that the ribbon-like
cross-section can greatly reduce brittleness of the alginate fibres [303].
Besides the ratio of guluronate/mannuronate residues in alginate, the ratio of sodium
cations to calcium (silver, zinc, magnesium, ammonium, etc.) cations also has significant
influence on the water absorbency and fibre mechanical properties.
Many wound dressings composed of mixed sodium and calcium alginate fibres have been
described [304]. The cation ratios in a mixed-salt alginate dressing are intended to achieve a
highly effective combination of properties. Bonniksen [291] proposed that the cation ratios
in alginate should be in such a proportion that the composition so formed can swell to any
desired degree in watery fluids to produce a gel-like slab but cannot disperse. Calcium
alginate fibres have been converted to a 50:50 Ca:Na mixed-salt fibre (on an equivalent
basis) to increase the solubility and to promote haemostasis [292, 295]. However, the 50:50
Ca:Na mixed-salt fibre was difficult to handle in contact with liquid wound exudates, and an
alternative ratio of sodium cations to calcium cations in the range from 30:70 to 15:85 was
recommended [305].
In addition to fibres, a method [306] of impregnating nonwoven absorbent pads with 5%
(by weight) of calcium alginate or a mixture of calcium and sodium alginate to form a
Nonwoven Wound Dressings 23

dressing with mixed cations has been reported. Alginate nonwoven dressings usually consist
of compression-bonded or needlepunched carded webs that are parallel-lapped or cross-
lapped before bonding. Perhaps surprisingly, hydroentangled alginate dressings have also
been commercially produced. Deionised water is required to prevent the gelling of fibres
during the process [307]. The production of spunlaid alginate filaments has also been
demonstrated, based on wet-spinning.
Alginate dressings are sometimes produced in combination with hydrocolloids or
activated charcoal for the control of malodourous wounds. A water-swellable but insoluble
wound-dressing material is described in US P 6 022 556, which comprises 5%–50%
of an alginate ester, or propylene glycol alginate. Insolubility is achieved by the addi-
tion of polyvalent cations such as calcium ions, or by covalent cross-linking of the PGA, or
by adding from 10 to 35% by weight of water-swellable polysaccharide such as gelatin, or by
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adding from 5% to 20% by weight of a cationic polymer such as chitosan.

Non-adhesive backing materials in alginate nonwoven wound dressings (US P 5 238 685,
US P 5 674 524, GB P 1 280 631, EP 0 243 069) help to reinforce the alginate-fibre fabric and
include permeable, semi-permeable or impermeable films, foams and fabrics, which can be
woven, knitted or nonwoven fabrics.
Various types of nonwoven dressing composed of alginate fibres have been commercially
developed [308, 309]. Some of these products are summarised below.
Tegagen (formerly Tegagel) wound dressing and the wound dressings reported in
EP 0 344 913 [307] comprise a wet-laid, hydroentangled nonwoven fabric made from
alginate staple fibres.
Sorbsan is a topical wound dressing composed of a carded and lapped web of calcium
alginate fibres that is compression-bonded. When in immediate contact with wound exudate,
it forms a soft, hydrocolloid gel.
A carded and needlepunched alginate nonwoven fabric is marketed as Kaltostat
haemostatic dressing. The ratio of sodium:calcium alginate is about 20:80. The fibres
absorb wound exudate or normal saline solution and form a robust hydrogel. Alginate tow
is also marketed under the same trade names for use as wound dressings, and especially for
surgical packing.
Kalginate is a calcium alginate nonwoven dressing composed of comparatively high-
linear-density alginate staple fibres. Largely because of its mass, the fabric absorbs large
quantities of exudate and maintains its structural integrity in the wet state, both at the
wound site and on removal. It is available as a nonwoven pad or as a rope dressing.
AlgiDerm is an absorbent conformable nonwoven wound dressing composed of calcium
alginate fibres.
Other example brands of alginate wound dressings are: Algosteril, Curasorb, Seasorb,
PolyMem, NU-DERM, Melgisorb, Algisite, Invacare and CalciCare.
Compared with woven and knitted dressings composed of alginate fibres, alginate
nonwovens are soft, conformable and cost-effective to manufacture. X-ray-detectable
alginate nonwoven dressings and surgical haemostats are described in US P 5 714 232 [310],
in which X-ray-detectable PVC strips containing barium sulphate are bonded to the basic
alginate-fibre nonwoven fabric. Collagen Collagen is an abundant structural protein found in animals. When

extracted and used in wound dressings, non-collagen proteins, glycosaminoglycans and
lipids must first be removed by, for example, an enzymatic treatment. This yields a product
24 Textile Progress

which is soluble in dilute acidic aqueous solutions (CIS-collagen in solution). As native

collagen is immunogenic, telopeptide collagen, which is non-immunogenic or possessed of a
negligibly low level of immunogenicity, is obtained for medical uses by removal of certain
terminal peptide chains in natural collagen [311].
Collagen matrices have been used for implantation into the human body to act as
supports for wounds and solid-tissue healing. Such matrices should have the ability to
adhere and conform to the wound site and surrounding tissue. Ideally, accumulation of
fibroblasts, endothelial cells and wound-healing regulatory cells should also be facilitated to
promote connective-tissue deposition and angiogenesis.
Different methods exist for producing collagen products such as fibres, films, foam and
composites. Usually, the original collagen fibres need to be separated and dispersed, and
unwanted materials removed. They must then be stabilised by cross-linking. Collagen
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dressings made by freeze-drying a dispersion of native collagen in a weak aqueous organic

acid solution [312] tend to possess tightly entangled fibres having a low absorptive capacity
and pore sizes that may not encourage optimum cell in-growth. A wound dressing
containing gently hydrolysed, native, insoluble collagen has been reported [313], in which a
fibrillar structure is left intact to give a substance that is excellent for producing films for
dressing materials. A carbodimide or succinimidyl ester cross-linked collagen sponge is also
described [314].
A method of preparing rope-like collagen structures has been reported [315]. The collagen
in solution is treated so that the collagen slowly separates from solution while exposed to
mild shear forces. This fibrous precipitate composed of regularly ordered collagen fibres
resembles a rope-like structure. These resulting aggregates are referred to as native fibrous
micropolymers (NFM). The fibrous micropolymers may be freed of salt, taken up in a
different solution or modified. For example, cross-linking may be introduced to stabilise the
Formation of collagen composites is also of interest. A composite polymeric material
composed of collagen fibres and suitable for biological and medical applications has been
proposed [316]. The composite material consists of a hydrophilic polymer based on
methacrylic or acrylic esters, fibrillar collagen, a cross-linking agent based on both polymeric
components, and other biologically active compounds as fillers and/or plasticisers. The
composite is prepared by dispersing the fibrillar collagen in a solution or a highly swollen
dispersion of the synthetic hydrophilic polymer in a lyotropic agent. The subsequent
removal of the lyotropic agent leads to the formation of the synthetic polymer or copolymer
matrix, which is penetrated by fibrillar collagen or vice versa. Another collagen composite
composed of collagen and oxidised regenerated cellulose (ORC) is described in WO 9 800 180
[318] and is intended for the treatment of chronic wounds, such as venous, decubitis and
diabetic ulcers. The dressing may be nonwoven or another textile structure suitable for direct
application to the surface of a wound. A biocompatible nonwoven fabric consisting of
ultrafine collagen fibres as the fundamental constituting unit has been discussed [318] and
wound-healing matrices formed of collagen fibrils without chemical cross-linking are also
known [319–321]. The bulk density of these matrices is in the range 0.01–0.3 g/cm3 and at
least 80% of the pores have an average size of 35–250 microns. The implants are said to be
capable of promoting connective-tissue deposition, angiogenesis, re-epithelialisation, and
fibroplasias. Such wound-healing matrices are claimed to be effective sustained delivery
systems for bioactive agents, such as the synergistic combinations of FGF and TGF-B.
A biomedical implant comprising a collagen matrix material and a biodegradable porosifying
Nonwoven Wound Dressings 25

agent has also been described [322]. As the porosifying agent degrades in situ, an implant
with an inter-connecting network is formed. The resultant mechanically-stable implant
allows tissue and fluid influx into the collagen matrix.
A wound dressing made of genetically-engineered human collagen that could allow faster
and improved healing of injuries has been developed by researchers in Israel [323]. The
dressing incorporates an inner layer of genetically-engineered, human recombinant collagen.
This material becomes a soluble, readily enzymatically degradable molecule in the wound
tissue. The molecular fragments that are formed have been shown to play an important role
in the healing process. An outer layer, also of biological origin, is provided in the wound
dressing to provide initial protection prior to release of the delicate collagen layer. Aliphatic Polyester Fibres Poly(lactic acid) (PLA) and poly(glycolic acid) (PGA)
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are important resorbable biomaterials. They are thermoplastic, hydrolytically biodegradable

polyester fibres produced from agricultural rather than petrochemical resources. After the
first PGA homopolymer [324–326], or polyglycolide, was produced in 1962, numerous
PLA, PGA and related copolymers have since been produced [327, 328]. They are present
in bioresorbable sutures, wound dressings, tissue matrices and ligament replacements. CMC Fibres Carboxymethyl cellulose (CMC) is characterised by good water-

retention capability and is an important constitutent in various nonwoven wound dressings
[329, 330]. A nonwoven wound dressing composed of carboxymethylated cellulose filaments
that are physiologically inert is known [331]. The wound-contact layer of the dressing is
composed of non-cross-linked carboxymethyl cellulose filaments capable of absorbing at
least fifteen times their own weight of 0.9% aqueous saline solution. The wound-contact
surface forms a swollen, transparent gel, which retains sufficient fibrous character to be
removed from the wound without collapsing. Sodium carboxymethyl cellulose fibres (e.g.
Hydrofibre) are converted into nonwoven fabrics (e.g. Aquacel [332]). On wetting with
wound exudate, the fibres convert to a soft, strong hydrogel providing a moist wound-
healing environment. The absorptive capacity of such CMC fibres is generally higher than
that of alginates, which gives rise to longer intervals between dressing changes, reduced
nursing time and lower overall wound-care cost [333]. CMC fibres dry out slowly and it is
claimed fibres will not be left in the wound on removal. Such dressings are indicated for use
on highly exuding wounds, including leg ulcers, minor burns, donor sites and pressure sores
[334]. The fibres are not haemostatic. Aquacel is composed of 100% Hydrofibre and is
mechanically bonded to form a soft, highly absorbent nonwoven fabric that has good gel-
blocking and fluid-retaining properties [335]. Robinson [336] reviewed the use of these highly
absorptive dressings in wound healing; Foster et al. [337] compared CMC and alginate-
fibre dressings in open acute surgical wound care, and Russell [338] studied the application
of Hydrofibre dressings in chronic wounds. Schulze et al. [339] evaluated the effect of
Hydrofibre dressings in the treatment of exuding venous leg ulcers. Other Special Materials Fibres composed of other speciality materials are also
used in dressings including branan ferulate, which is a polysaccharide or carbohydrate
polymer extracted from corn bran [340, 341]. Other fibres that are used in wound dressings,
but not necessarily as the wound-contact layer, are carbon fibre, poly(hyaluronic acid) (HA)
[342], hyaluronan derivatives [343] and starch-based materials. A nonwoven absorbent
fabric composed of biodegradable polyhydroxyalkanoate (PHA) copolymers is claimed to
be suitable for use in wound dressings [344] and a nonwoven fabric containing microfungal
26 Textile Progress

hyphae fibres has been revealed [345]. The nonwoven comprises a wet-laid web of micro-
fungal hyphae fibres treated with a plasticiser before the hyphae are allowed to dry, to
prevent embrittlement. Various applications for the fabrics are envisaged, including wound
dressings and metallic-ion-capture substrates.
Other developments include a dressing consisting of a cellulose diacetate and poly-
vinylpyrrolidone fibre blend in a weight ratio of 4:1 to 10:1 [346] and a lyophilised foam
sponge product formed from hydrocolloids (e.g. gelatin, pectin, and sodium carboxy-
methylcellulose) with a density of 0.01–0.10 g/cm3 [347]. The dressing is prepared by forming
an aqueous colloidal dispersion of hydrocolloids, aerating or foaming, freezing, and lyo-
philising. Other natural and synthetic fibres, including banana-leaf fibres [348] and carbo-
hydrate polymer fibres, [349] have also been documented for use in wound dressings.
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3.1.3 Electrospun Nanofibres

In addition to the conventional methods of nonwoven fabric manufacture, various materials
have been made into nanofibres to produce nonwoven wound dressings (and tissue-
engineering scaffolds) to promote cell attachment, adhesion, growth, spreading and
proliferation, due to the nanofibre fabrics having a wide range of pore-size distribution,
high porosity and high specific surface area. Nanopowders of carbon, silver, copper and
collagen [350] are coated or bonded to nonwoven fabrics to make multi-functional wound
dressings. In last few years, electrospun nanofibres [119, 128] used in nonwoven wound
dressings [351, 352], tissue-engineering matrices [119, 128], and artificial scaffolds [353] have
been intensively investigated. One of the major advantages of electrospun nanofibres (from
50 nanometres to about 10 microns) in nonwoven dressings is the ability to collect the
nanofibres and form them into nonwoven mats of any desired shape and thickness. In
nanofibre nonwoven dressings, there are small interstices and a high surface area per unit
mass [354]. These properties are very important for fluid transport and act as a barrier to
harmful particles, liquids, viruses and bacteria [355].
Some speciality materials that are difficult to convert into yarns or woven and knitted
fabrics can be formed as nanofibres and incorporated into dressings. Fibrinogen, a blood
protein extracted from blood, has been made into nanofibres to produce biodegradable
nonwoven bandages [356] which can stop bleeding quickly, and speed up the healing
process. Silk fibroin (SF) nanofibres have been described as cell-culturing scaffolds for
normal human keratinocytes and fibroblasts [357, 358].

3.2 Manufacture of Nonwoven Wound Dressing Structures

Details of nonwoven manufacturing technologies are available in previous issues of Textile
Progress [359], handbooks and journals. This section gives a brief overview of some of the
manufacturing techniques that are utilised in the manufacture of nonwoven fabrics found
in dressings.
Nonwoven dressing fabrics are constructed from polymeric continuous filaments, staple
fibres or a combination of both in flexible composites. The manufacturing procedures
for converting natural and man-made fibres into nonwovens are well established. For
commercial staple-fibre dressings, webs are formed by the wet-laid and dry-laid routes.
Depending on the precursor web type and the intended application, fabrics are then
stabilised by chemical bonding, mechanical bonding (usually needlepunching or hydro-
entanglement), mechanical compression or thermal bonding (through-air convection
or point-bonding using conduction methods). Conventional, nonwoven dressing fabrics
Nonwoven Wound Dressings 27

composed of continuous filaments are produced from either melt-spun polymers in

spunbonded or meltblown form, or in certain cases by the wet-spinning of polymer solutions
in both spunlaid and electrospun forms. In carding, materials such as calcium alginate and
superabsorbent fibre may be subject to significant fibre breakage and low web cohesion in
dry-laid processes, which affect yield. Narrow-width cards operating at low production
speeds are frequently utilised in conjunction with cross-lapping and needlepunching for
producing absorbent pads and various contact layers from gel-forming and superabsorbent
fibres. This approach enables highly porous fabrics containing no extraneous contaminants
to be produced by using a relatively inexpensive and highly versatile process. The fabric
porosity can be adjusted during needlepunching and may be purposely graduated from one
side to the other to influence liquid transport and the rate of absorption as required.
Needlepunching is also used to manufacture composite dressings where two webs containing
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gel-forming fibres are needlepunched to both sides of a reinforcing scrim [360]. Composites
containing a carded web and polyurethane foam, which acts as the absorbent, and an inner
skin-facing layer in a compression bandage system are produced in this way [361].
Hydroentangled (spunlaced) fabrics are favoured because they are low linting, comformable,
clean and soft. They also have a pore structure that can be adjusted during fabric production
and different layers can be mechanically laminated during the process to produce absorbent
composites. Most fibres are compatible with hydroentanglement; even some hydroentangled
alginate dressings are manufactured. The structural patterning and aperturing capabilities of
hydroentanglement have long been exploited in the production of dressings. Many are
superficially gauze-like in appearance, having apertures of different shapes, dimensions and
spatial arrangements. Hydroentangled fabrics with parallel ribs interconnected by loose fibre
bundles extending between adjacent ribs are claimed to produce dressings with particularly
good absorbency [362]. Chemically-bonded fabrics are found in certain composite dressings,
for example, as barriers to liquid-borne bacteria [363]. One type of body-fluid-absorbent pad
is composed of wood pulp bonded with thermoplastic fibres such as the polyolefins [364].
Polyethylene, polypropylene and polyester spunbonded and meltblown fabrics provide low-
adherent permeable wound-contact layers that possess good mechanical properties [371,
365, 366]. Nonwovens combined with hydrophobic silicone finishes are also intended as non-
adherent layers [104, 105, 106] and assist in the reduction of skin tears [367].


In this section, the function of nonwoven components in wound dressings is reviewed.

4.1 Nonwoven Fabrics in Wound Dressings

Although monolithic nonwoven wound-dressing fabrics are used, it is increasingly common
for nonwovens to be combined with other types of nonwoven, films, knitted fabrics [369] or
other absorbent materials [370] to improve liquid transport, mechanical properties, wound
healing or low adhesion [371]. For example, composite nonwoven wound dressings
comprising at least two layers of hydrophobic microfibre fabrics and at least one nonwoven
fabric have been reported [372]. A disposable surgical towel with multiple layers of absorbent
nonwoven fabrics and a layer of low-density meltblown fabric has also been described [373].
While the structure and performance of nonwoven wound dressings can be manipulated
by using various manufacture techniques as shown in Section 3.2, the properties of
nonwoven dressings can be manipulated by selecting different fibre compositions and fabric
28 Textile Progress

structural parameters and dimensions, including fibre diameter and fabric density. Polyester,
viscose, polypropylene, polyethylene and their blends [374] are widely used to form
nonwoven components in dressing composites. A multilayer dressing [375] in which each
layer consists of fibres with progressively decreasing linear density is reported to have a high
drying rate and an improved rate of in-plane body fluid penetration. A nonwoven dressing
structure that allows interchange of the position of the low and high density layers to aid
wound healing has also been developed [376].
The applications of nonwoven fabrics, used either as a monolayer or as a component in
composite wound dressings cited in the patent literature, may be classified as follows:
(i) active agent carriers;
(ii) liquid absorption, transfer and barriers;
(iii) high conformability components;
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(iv) mechanical reinforcement;

(v) low-adherent contact layers [377].

4.1.1 Active Agent Carriers in Wound Dressings

Nonwovens are suitable for incorporating various medical agents to provide controllable
drug release and additional functionality in wound care. Active agents include antiseptic
agents [223], silver ions [378], antibacterial agents [379, 380] and tea tree oil [381], which
reduces heat around the wound and provides bacteria-static properties to promote healing
and debridement of the wound. Examples of nonwoven structures suitable for incorporating
with these active agents are:
single-layer hypoallergenic nonwoven fabric,
multi-layer nonwoven fabric,
laminate of a perforated polyurethane film and an absorptive nonwoven fabric, and
nonwoven structure containing a mixture of hydrophobic fibres and fibres comprising
the antimicrobial active compound.
When incorporated with certain polymers, nonwoven structures can be used as a liquid
storage component and for the controlled release of active substances to wounds [382].
4.1.2 Liquid Absorption, Transfer and Barriers
Numerous dressings are aimed at improving the absorption rate of body liquid or blood,
liquid transport, after absorption, or reducing leakage by including nonwoven fabric
components [383, 384]. These can be achieved by various techniques including [358–387]:
the use of water-absorbent polymers,
the deposition or coating of absorbent polymers onto an existing absorbent layer,
the use of a hydrophilic diffusion layer comprising a nonwoven fabric, and
the combination of the contact layer (liquid-permeable surface) with a nonwoven
Examples of methods to increase the absorbency of nonwoven fabrics include coating
of a polyelectrolyte superabsorbent onto the fibres in a preformed web [388], spun-
bonded fabrics having an array of discrete surface features such as apertures or projec-
tions [389], incorporation of water-swellable but insoluble fibres [390], the combination
of wicking fibres with high-absorbency polymeric particles and utilisation of meltblown
webs [391].
Nonwoven Wound Dressings 29

The absorptive capacity and the liquid transfer of a compacted nonwoven fabric are
reported to be greater than that of a hydroentangled fabric of the same weight and fibre
composition [392].
In composite wound dressings, absorbent nonwoven structures are frequently combined
with thin films, which are impermeable to liquid water and bacteria but permeable to water
vapour. This provides protection for a patient from sources of infection external to the skin,
helps to retain body fluids at the wound site and allows the skin to breathe normally [393].
For example, a composite dressing has been designed having a layer of low density absor-
bent fabric covered by an upper layer of high density fabric. The wicking rate of the cover is
higher than that of the low density layer. These two layers are placed between a permeable,
non-adherent, bacteria barrier and a lower perforated sheet [225]. Another example of such
a composite structure consists of a laminated nonwoven absorbent fabric with a film to
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produce an absorbent, non-adherent dressing [394]. The nonwoven absorbs the body fluid
while the support film is transparent or translucent permitting visual inspection of the pad.
Four composite wound-dressing structures containing absorbent pads have been defined
in the BP [395]: impermeable plastics wound dressing (waterproof plastics wound dressing);
permeable plastics wound dressing; vapour-permeable waterproof plastics wound dressing;
and perforated-film absorbent dressing. These composite wound dressings usually consist of
three layers: a film or a pad protector layer in contact with the wound surface, an absorbent
pad, and a back layer, which is usually waterproof and permeable to gas/water vapour.
The nonwoven absorbent cores in the three types of perforated-film absorbent dressing
defined in the BP differ in their suitability for use with wounds generating high and low
amounts of exudate. In Type 1, the absorbent middle layer is a nonwoven material
consisting of bleached cotton or viscose together with polyacrylonitrile fibres. The wound-
facing layer is a film of PET perforated in a regular pattern, and the backing layer is an
apertured nonwoven cellulosic material. For Type 2, the absorbent middle layer is a
nonwoven material consisting of bleached cotton, and the wound-facing layer is similar to
that of Type 1. The backing layer is identical to the wound-facing layer. For Type 3, the
absorbent middle layer is a nonwoven consisting of bleached cotton or viscose fibres or a
mixture of both sandwiched between two layers of an apertured cellulosic nonwoven. The
outer layer is a sleeve consisting of a film of PET, perforated in a regular pattern.
Nonwovens containing superabsorbents make a highly effective absorbent core in wound
dressings. Superabsorbent powders, granules and fibres are available. The fibre sources
include polyacrylate-based Oasis superabsorbent fibre (Oasis SAF) [395A] and multi-
component superabsorbent fibres from BASF [395B]. Both hydrophilic fibres [396] and
hydrophobic fibres [397] may be incorporated with appropriate superabsorbent materials.
The nonwoven structure itself can be a composite. For example, an absorbent construct
composed of a polypropylene nonwoven fabric sandwiched between two layers of cellulose
tissue [398] has been described.
Combining both hydrophobic and hydrophilic fibres in a composite hydroentangled
dressing has been considered. Such layered dressings can exhibit good liquid absorbency
as well as provide a barrier against bacteria. The hydrophobic nonwoven layer acts as the
wound-contact layer and exudate passes through the water-permeable hydrophobic layer
to be absorbed by the hydrophilic core layer [399]. An extensible and water-impervious
microfibre laminate has been designed to increase hydrostatic head at higher extension [400].
In this laminate, a creped hydrophobic microfibre structure is sandwiched between and
bonded to two reinforcing layers of nonwoven fabric. The purpose of the creped microfibre
30 Textile Progress

inner layer is to minimise liquid absorption in the laminate and to prevent liquid strike-
through, even after considerable fabric extension.
4.1.3 High Conformability Components
Good conformance with the wound site is required in a dressing. Recovery from extension
or deformations imposed on the dressing during application or in situ is also desirable. Many
biocompatible polymer films have excellent barrier properties and elasticity or stretch-
recovery but are fragile, easily curl and can readily catch on rough objects, resulting in
damage. Most nonwovens do not have good elasticity but many have high extensibility and
good absorbency. Therefore, nonwoven fabrics used in dressings have been incorporated
with elastomeric films [401], elastic meltblown aromatic polyether urethane nonwoven
membranes [402–404], and elastomeric moulded copolymers [405] to improve dressing
comfort and fit. A further option is microcreping of the fabric. The recent introduction of
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elastomeric spunbonded fabrics [405A, 405B] provides additional opportunity for the design
of conformable wound dressings.
When dressings are applied over a relatively large wound at bending sites of the body,
such as the elbows and knees, nonwovens having high extensibility may be useful support
components in an adhesive bandage [406]. A corrugated nonwoven fabric having contiguous
anti-nodes of adjacent waves has good stretch for medical and surgical compresses [407].
Absorbent nonwovens also form part of dressings that are applied as part of a
temperature pack to promote wound healing. Such dressings are composed of an elongated
pack, which is applied to the body for the purpose of increasing or decreasing the
temperature of the patient [408].
4.1.4 Mechanical Reinforcement and Moisture Control in the Back Layer
A sponge wound dressing can be reinforced by a point-bonded nonwoven [409] and a
meltblown nonwoven web [410], rather than a conventional spunbonded fabric.
Attempts to improve the cross-directional extension of dressings have also been made
[411]. The fabric is elongated in the cross direction and then necked to increase the extension
in this direction. The resultant nonwoven is highly extensible and is suitable for use in
wound dressings, bandages, and personal care articles as well as wipes and tissues.
In commercial dressings containing absorbent components, the backing and secondary
retaining layers are important. The backing layer of a dressing can be adhesive or non-
adhesive. Adhesive is used to keep the wound pad in place on the backing layer and to the
wound area. The adhesive should be impermeable to liquid water but permeable to moisture
vapour. Adhesive materials for alginate wound dressings are recommended to have a
moisture vapour permeability of at least 300 g m 2 day 1 at 40 8C/80% r.h. [412].
Besides absorbent dressing cores, nonwovens having high extension may form the back
layer of adhesive bandages and dressings to control the conformity [413], and water vapour
transport [414] of the dressing.

4.2 Examples of Nonwoven Components in British Drug Tariff Wound Dressings

Nonwoven fabrics provide dressings with a great variety of functionalities with respect to
conformability, absorbency, structural integrity, and liquid and gas permeability, and as a
carrier for functional components and topical agents. Examples of nonwoven components
and their function in wound dressings in relation to the British Drug Tariff are shown
in Table 4 [415–417]. This is an indicative but not an exhaustive list of the variety of
nonwoven wound-dressing products that are available.
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Table 4
Examples of Nonwoven Components in Wound Dressings from the British Drug Tariff
Name Type Structure Function of Nonwoven Manufacturer
Algisite M Primary Dressing– A primary needled nonwoven made from calcium Absorbent, conformable Smith & Nephew
Calcium alginate alginate fibres, rich in mannuronic acid. Healthcare Ltd
Kaltostat Dressing–Hydrofibre An absorbent mechanical-bonded fabric composed Highly absorbent, ConvaTec Ltd
of staple fibres of sodium and calcium salts of alginic gel forming
acid in the ratio of 80:20.
Tegagen Dressing–Calcium Hydroentangled, calcium alginate nonwoven dressing. Good wet integrity 3M Health
alginate Care Ltd
Aquacel; Dressing–Hydrofibre A soft, hydrophilic nonwoven ribbon or flat dressing Superabsorbent, ConvaTec Ltd
Aquacel composed of hydrocolloid fibres (sodium gel forming
ribbon carboxymethylcellulose).
Acticoat 7 Primary dressing– Two layers of silver-coated polyethylene mesh and >
> Absorbent core (hydro- Smith & Nephew
[418] Silver-coated >
an inner core (two layers of an apertured nonwoven>
> philic and hydrophobic), Healthcare Ltd
low-adherent made from rayon and polyester plus a layer of >
= support layer to [419]
silver-coated PU). silver-coated layers.
Acticoat Two layers of silver-coated polyethylene mesh and >
an inner core (one layer of an apertured nonwoven >
made from rayon and polyester). ;
Mepilex Island dressing– An absorbent, self-adhesive island dressing Absorbent core Mölnlycke
Nonwoven Wound Dressings

Border Self-adhesive, with a perforated soft silicone wound-contact Healthcare Ltd

silicone faced, layer. The absorbent core of the dressing consists
polyurethane foam of three components (a sheet of polyurethane foam,
a piece of nonwoven fabric and a layer of
superabsorbent polyacrylate fibres). The core
is located upon a polyurethane film and is
held by the perforated silicone adhesive layer.
Release Dressing–Low- A textured, perforated sleeve of EMA (ethylene- Liquid acquisition and Johnson & Johnson
adherent, absorbent methyl acrylate) open at two ends, surrounding an distribution Medical Ltd
absorbent core consisting of viscose fibres enclosed
between two liquid-distribution layers of nonwoven
Lyofoam C Dressing– A layer of a nonwoven fabric, impregnated with Carrier of carbon Seton Healthcare
Polyurethane foam activated carbon granules, is sandwiched between granules Group plc
with activated the two Lyofoam polyurethane composite sheets.

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Table 4 (Continued)

Name Type Structure Function of Nonwoven Manufacturer

Mepiform Dressing–Self- A viscose nonwoven fabric coated with silicone Carrier of silicone, water Mölnlycke
adhesive soft silicone and bonded to a semipermeable polyurethane vapour permeable Healthcare Ltd
scar treatment membrane.
Micropore Tape–Permeable, A conformable, non-extensible viscose nonwoven Permeable to water and 3M Health
nonwoven with fabric coated with a layer of an acrylic adhesive. water vapour, Care Ltd
synthetic adhesive radio-transparent.
Hypafix Tape–Apertured, An apertured, nonwoven polyester fabric coated The apertured structure Smith & Nephew
nonwoven, with a layer of acrylic adhesive, and protected on imparts a lateral extensibility, Healthcare Ltd
synthetic adhesive the roll by a release paper backing. conformability and
permeability to the product.
Mefix Tape–Apertured, An apertured, nonwoven polyester fabric coated Mölnlycke
nonwoven, with a layer of an acrylic adhesive, and protected Healthcare Ltd
synthetic adhesive by a release paper backing.
Melolin Dressing–Perforated A perforated film of poly(ethylene terephthalate), Absorbent, permeable, Smith & Nephew
film absorbent BP bonded to an absorbent layer consisting of a backing layer Healthcare Ltd
(Type 1) blend of cotton and polyacrylonitrile fibres, backed
with a layer of an apertured nonwoven cellulose
Mepore Island dressing– A self-adhesive absorbent dressing that has an absorbent Permeable and flexible. The Mölnlycke
Textile Progress

Nonwoven fabric wound pad located centrally on a piece of apertured, polyester backing layer and Healthcare Ltd
adhesive nonwoven polyester fabric coated with a layer of an acrylic viscose absorbent layer are
adhesive. The wound pad is a viscose nonwoven coated with also the acrylic adhesive and
a polyolefin layer to give a smooth surface and render it polyolefin carriers respectively.
Proguide Multilayer bandage– Comprises a kit containing three components: a Nonwoven layer is to protect bony Smith & Nephew
compression system primary dressing composed of PU foam composite, prominences from excess pressure, Healthcare Ltd
a roll of absorbent padding and an elastic, woven but it also serves as a secondary
compression bandage. The padding layer is absorbent layer in the treatment of
formed from a polyester and viscose fibre blend. heavily exuding ulcers.
Actisorb Dressing with Consists of activated carbon impregnated with Support layer to silver-coated Johnson & Johnson
Silver 220 activated charcoal metallic silver. The carbonised fabric is sealed in layers; facilitate handling Medical Ltd
cloth and silver a sleeve of a nylon spunbonded fabric to facilitate particle and fibre loss.
handling and reduce particle and fibre loss.
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Coban Bandage–light A water-vapour-permeable, nonwoven polyester fabric Elastic, water-vapour- 3M Health

pressure and containing longitudinal strands of polyesterurethane permeable support layer. Care Ltd
support, cohesive (elastane) copolymer. The fabric is coated with a self-
adherent substance that enables the bandage to cohere
but not to adhere to skin or clothing.
Tielle Polyurethane foam Island dressing with a multi-layered structure Liquid-distribution layer Johnson & Johnson
self-adhesive island consisting of a sheet of absorbent polyurethane foam Medical Ltd
dressing applied to the centre of an adhesive polyurethane
membrane. A nonwoven fabric located between the
foam island and the adhesive backing acts as a
wicking layer to facilitate distribution of exudates.
Tielle Plus; The wound-contact layers and backings in Tielle Plus and Liquid absorption and Johnson & Johnson
Tielle Plus Tielle Plus Borderless are the same as in Tielle. The middle retention Medical Ltd
Borderless layer is a low density nonwoven containing a blend of
viscose and superabsorbent acrylate fibres to facilitate the
absorption and retention of excess fluid.
Nonwoven Wound Dressings
34 Textile Progress


5.1 General Background
Defined as a new science in 1988 [420], tissue-engineering is referred to as ‘an inter-
disciplinary field that applies principles of engineering and the life sciences toward the
development of biological substitutes that restore, maintain, and improve the function of
damaged tissues and organs’ [420, 421].
Tissue-engineering provides opportunities to design advanced wound dressings, which will
either deliver cells to a wound site or guide the process of tissue repair by direct interaction
with cells. The science of tissue-engineering has grown from the desire to produce substitute
organs and tissues in response to problems caused by the persistent shortage of human
donors [422].
The basic concepts of modern tissue-engineering using biodegradable polymer scaffolds
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and cells were pioneered in Boston, USA, in 1955 and during the early 1960s [423]. This
sophisticated biological approach in wound healing with the use of artificial skin substitutes
began in the burns area in the 1970s [424]. The transplantation of extrarenal solid organs
was still largely experimental until the late 1970s although the mechanisms of cell growth
had been studied [425, 426]. In 1981, the first artificial skins by O’Connor et al. [427] and by
Burke et al. [428] in treating burn injuries were reported. Russell [429] reviewed the concept
of selective cell transplantation, and conceptually this offered a potential methodology for
the restoration of tissue function. Inspired by the previous work, Vacanti [430] applied the
principles of selective cell transplantation using three-dimensional synthetic biodegradable
polymer matrices to create visceral organs in vitro.
From the 1990s, it was established that cell migration, replication and differentiation,
and the synthesis of extracellular matrix (ECM) are common to wound healing, embryonic
development and tumour growth. As a result of developments in cellular and molecular
biology, the mechanisms of normal wound healing and ways in which this can be
manipulated are being further elucidated [24].
In recent decades, matrices made from new synthetic materials and material-processing
techniques have been used in forming blood vessels and intestine [123, 431, 432], liver,
ligament, tendon, bone, specific shapes of cartilage for the ear [433], finger [434] and heart-
valves [435]. Although the development of entirely man-made organs (in vitro) and tissues
(e.g. kidneys, skin, liver) for transplantation over the last forty years has been remarkable,
these substitutes do not function as well as natural organs or tissues [436].
Some general strategies are utilised in the creation of new tissue including [421]:

(i) the replacement of only those isolated cells or cell substitutes needed to restore
(ii) the production and delivery of tissue-inducing substances such as growth factors and
signal molecules;
(iii) the placing of cells on or within a matrix fashioned from synthetic polymers (e.g.
textile materials) or natural substances such as collagen; the matrix may be an open
or a closed system.

Open cell-matrix systems are designed to be implanted in the body to become completely
integrated with the host tissue, allowing free transport of molecules and cells between the
host tissue and implanted cells. A closed matrix system may be transplanted in the body
or used as an extracorporeal device [421, 437]. In a closed matrix system, cells are isolated
Nonwoven Wound Dressings 35

from the body by a membrane that permits nutrient and gas exchange while acting as a
barrier for large entities such as antibodies and white cells [438].

5.2 Development of Interactive Wound Dressings and Artificial Skin Substitutes

Modern cell-based wound therapies are effective in accelerating wound repair and their
appropriate use may achieve closure in wounds which may not heal under other wound
therapy techniques. There are various types of allogeneic skin substitutes, including cultured
epidermal substitute (CES), cultured dermal substitute (CDS), and cultured skin sub-
stitute (CSS). These are composed of keratinocytes and/or fibroblasts, and the cellular
component(s) have been used as biological wound dressings [439] or artificial skin
Biologically active wound dressings, based on collagen [440], chitosan [211], hyaluronic
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acid [213], peptides [441] and growth factors [442–444] have been in development. The
advancements in biomaterials and tissue-engineered skin equivalents [445, 446], both cell-
free matrices (acellular matrices) and cell-containing matrices [447], have led to several
products [448], such as Dermagraft [449] and Apligraf [450], Alloderm [451], Oasis [452] and
Integra [84], available commercially.
A summary and comparison of the clinical applications of these artificial skin substitutes
can be found in the literature [63, 453], and the details of the history of cultured epithelial
autografts can be found elsewhere [454, 455]. An overview of the current advances and
challenges in the field of biological skin substitutes has been given by Jones et al. [456].

5.3 The Ideal Matrix

Certain criteria are considered essential for an ideal cell transplantation matrix. The ideal
matrix should elicit specific cellular functions and direct cell–cell interactions. It should also
be biocompatible, it should not induce a tissue response in the host, and it should be
completely resorbable, leaving a totally natural tissue replacement following degradation
of the polymer. The rate of degradation of the matrix is also important; if the degradation
is too rapid, mechanical support of the regenerating tissue and cell guidance is adversely
The proper design of these matrices may allow them to mimic the entire range of
mechanical and biological functions of the native extracellular matrix (ECM) which
normally exists in the body. Biomimetic synthetic polymers armed with cell-adhesion
peptides can be synthesised as implants for tissue regeneration or cell transplantation to
achieve this purpose [457]. Summaries of various aspects (e.g. material selection, fabrication,
porous architecture) of matrix design for tissue-engineering can be found in the literature
The matrix structure chosen to provide a basis for cell delivery is of the utmost
importance. For example, in tissue-engineering of the genitourinary system, the traditional
support structures have been mainly lithogenic (PTFE, silicone) [462]. Polymer matrices
can be used to achieve cell delivery with high loading and efficiency to specific sites
[463, 464]. The matrix also provides mechanical support against compressive and tensile
forces, thus maintaining the shape and integrity of the scaffold in the aggressive environment
of the body.
As a vehicle for cell delivery, the matrix should provide mechanical support to maintain
a space for tissue to form [502]. The interaction of the surface of the matrix with cells
should support differentiated cell function and growth [490], and in certain situations should
36 Textile Progress

induce in-growth of desirable cell types from surrounding tissue. The optimal matrix
microstructure is to some extent determined by the tissue to be transplanted. Generally,
matrix structures should be open with high porosity to allow cells to penetrate into the
scaffold and to give a high cell-seeding density. It is also important that nutrients can reach
the cells and there should be a large surface area to volume ratio for cell–polymer
interactions [490]. Agrawal and Ray suggested that a porosity of at least 90% is ideal for
specific scaffold–cell interactions, nutrient and waste diffusion, and sufficient space for
extracellular matrix (ECM) regeneration within the scaffold [465].
A tissue-engineered scaffold should be mechanically stable [466], regulating cell activities
[467] and capable of functioning biologically in the implant site [468]. Mechanical stability is
dependent primarily on the selection of the biomaterial of the ECM, the ECM architectural
design, and the cell–material interactions. Biologic functioning is regulated by biologic
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signals from growth factors and the surrounding cells and also determined by the ECM [469].
The matrix should be easy to reproduce in a variety of shapes and structures and retain its
shape when implanted.

5.4 Design of the Cell/Fibre Matrix

Matrix scaffolds are utilised to provide a structural framework for selected cells and to
deliver the cells to desired sites in the body, to define a potential space for ingress of the
engineered tissue, and to guide the process of tissue development. While direct injection
of cell suspension without the use of a matrix has been utilised [470, 471], it is difficult to
control the placement of transplanted cells. In addition, the majority of mammalian cell
types are anchorage-dependent and will die if not provided with a suitable substrate to which
they can adhere.
The structural parameters for designing a scaffold matrix, particularly relating to cell
penetration and cell attachment, were studied by many researchers [472]. The design of an
ECM structure includes two important aspects, namely polymer chemistry (biocompatible,
biodegradable, non-toxic and non-carcinogenic) and physical morphology of ECM. The
latter include ECM geometrical architecture [473] and the dimensions of its building
components (fibre dimensions and alignments [474], porosity and pore structures [475],
polymer surface topography [476, 477]). The chemical characteristics of a material surface
will mediate the adsorption of the biological molecules that regulate cell activities, such as
adhesion and migration [478]. Cell behaviour such as cell proliferation is also known to be
regulated by the architectural scale of the ECM structure [479] and adhesion is affected
by the topography of the material [480].
Summaries of various aspects (e.g. material selection, fabrication, porous architecture) in
the matrix design for tissue-engineering can be found in the literature [481–484].

5.4.1 Polymer and Fibre Selection

A variety of naturally occurring and synthetic polymers can be processed reproducibly
and designed to exhibit the necessary mechanical properties [487]. Naturally derived
materials (e.g. hyaluronic acid and collagen in ECM) must be isolated from plant,
animal, or human tissues. Typically, they are expensive and suffer from large batch-to-
batch property variations. Synthetic polymeric materials, on the other hand, can be more
precisely controlled with respect to their physical properties and dimensions. Moreover,
synthetic polymers are processed using established techniques and are supplied con-
sistently in relatively large quantities. The mechanical and physical properties of synthetic
Nonwoven Wound Dressings 37

polymers can be readily adjusted through variation of their molecular structures in order
to meet the functional requirements of the application without the use of either fillers
or additives.
A variety of synthetic polymers, both degradable and non-degradable, have been utilised
to fabricate tissue-engineered matrices [485, 486]. Langer [487] used biodegradable tubular
structures with cultured smooth muscle cells obtained from bladder wall biopsies. In 1994,
Mooney et al. [488] attempted to engineer urologic structures, which involved implanting
collagen sponge tubes as ureteral replacements in animals. The formation of an epithelial
cell-lined tubular tissue was intended, but salt deposits on the collagen matrix were observed
when the structure was exposed to urine.
Because permanent polymers carry the risk of infection, calcification, and unfavourable
connective-tissue response, the use of biodegradable synthetic polymers which break down
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harmlessly in the body is particularly attractive in tissue-engineering. The bioresorption or

disintegration of these materials after they have fulfilled their function minimises the
possibility of chronic foreign body response and leads to the formation of a completely
natural tissue.
A variety of synthetic biodegradable polymers may be utilised as structural elements in the
scaffold and to deliver or immobilise cells, e.g. PGA (poly(glycolic acid)), PLA (poly(lactic
acid)), PHB (poly(b-hydroxbutyrate)), PCL (poly(caprolactone)), PEO (poly(ethylene oxide)),
PVAlcohol, pluronics and poly(phosphazene) [489]. Hydrogels, in the form of either
synthetic polymers or natural polysaccharides, have been utilised to immobilise transplanted
cells. Natural polysaccharides and proteins can be either chemically modified or combined
with synthetic polymers to induce desirable properties for specific applications. The use
of synthetic biomaterials as vascular substitutes was initiated in the early 1950s with the
development of plastics and other polymeric substances, and such materials are now in
widespread use.
It is indicated that polymers in the group of polyesters, specifically the family of
poly(lactic acid) (PLA) and poly(glycolic acid) (PGA) and copolymers of lactic and glycolic
acids (PLGAs), most closely fulfil the criteria outlined above, including biocompatibility,
processibility, and controlled degradation [490], and they have been widely used in tissue
matrices [485, 491–495]. These polymers, many descendants of absorbable suture materials
developed two decades ago [485], are approved for in vivo use by the FDA for certain
applications and are readily processible into a variety of shapes and forms using melt and
solvent techniques [485, 490]. They can be produced into a variety of structures, including
fibres and porous films. These polymers are favoured because they have been shown to be
biocompatible, processable, and biodegradable.
The polymers’ degradation by hydrolysis, leaving natural metabolic intermediates, and
the resorption rates could be designed to vary from months to years, depending on the
ratio of the monomers [490]. In addition, the polymers could potentially be manufactured to
provide controlled release of hormones and growth factors [496].
PTFE [497], which serves as a nonabsorbable microfibrillar structural support,
is frequently found in implant matrices. Other examples of PTFE compositions used as
implants can also be found in US P 5 098 779 and US P 4 863 974.

5.4.2 Pore Structures

Other structural parameters governing cell penetration and migration within the scaffold
are pore size and pore interconnectivity [437]. The porosity, pore-size distribution, and
38 Textile Progress

continuity dictate the interaction of porous materials and transplanted cells with the host
The process of cell transplantation results in the formation of a capillary network in the
developing tissue [498]. Fibrovascular tissue will invade a device if the pores are larger
than 10 mm, and the rate of invasion will increase with the pore size and total porosity of
a device [498–500]. Some of the engineered tissue may be required to meet the metabolic
requirements of the tissue and integrate it with the surrounding host. In urologic
applications it may also be desirable to have a nonporous luminal surface to prevent
leakage of urine from the tissue [501].
The matrices may act as a physical barrier to the immune system of the host or act as a
frame for tissue regeneration, depending on the design of the scaffold. Immunoprotective
devices utilise a semipermeable membrane to limit interactions between cells in the device
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and the host. The small pores in these devices (d , 10 nm) allow low molecular weight
proteins and molecules to be transported between the implant and the host tissue, but they
prevent large proteins (e.g. immunoglobulins) and the host cells (e.g. lymphocytes) of the
immune system from entering the device and mediating rejection of the transplanted cells.
In contrast, open structures with large pore sizes (d . 10 mm) are typically utilised if the
new tissue is expected to integrate with the host tissue [502].
Pore size also controls how effectively the cells of various sizes can penetrate into the
three-dimensional network and how effectively nutrients can be delivered to the cells once
they have been seeded [490]. If the pore size is too small, cells will be unable to initially
penetrate the scaffold and subsequently migrate to other regions of the scaffold to produce
uniform cell seeding throughout. If the pore size is too large, cells will be unable to bridge the
pore during cell proliferation, thus inhibiting effective neo-tissue generation.
It has been observed that fabric architecture including fibre alignments (i.e. fibre orienta-
tion) in fibrous scaffolds can positively influence the orientation of collagen fibre. When
random and parallel-oriented scaffolds were seeded with cells, collagen-fibre orientation
was increased in the parallel direction in the early stages of static in vivo culturing [503, 504].
The morphology of the matrices can guide the structure of an engineered tissue, includ-
ing the size, shape, and vascularisation of the tissue [490]. Open, porous, three-dimensional
structures using degradable polymers have been designed to maximise diffusion parameters
and to permit vascular in-growth into the implanted structures [505, 506].

5.5 Formation of Nonwoven Matrices

Most of the technologies to form nonwoven structures can be used to make matrices from
both polymer melt and polymer solutions for tissue-engineering applications. Different
processing technologies adopted to produce highly porous nonwoven matrices from polymer
depend on the materials to be used, the requirements of the matrix structures and economic
cost. Usually melt processes are preferred due to economical and ecological aspects.
Important polymers for implants such as poly(glycolic acid) and poly(ethylene terephtha-
late) can be processed from the melt polymer only [507]. Needlepunched, thermal-bonded,
resin-bonded [508], chemical cross-linked [509], spunbond [510] and electrospun [511]
methods are all employed to manufacture nonwoven matrices.

5.6 Tissue-engineering Applications

The fabrication of tissue-engineered nasal cartilage has been facilitated by using flexible,
nonwoven PGA polymer mesh which was exposed to a 5% solution of poly(lactic acid) to
Nonwoven Wound Dressings 39

bond the PGA fibres [512]. The specific shape and size of the implants was maintained as the
polymer degraded, and the newly-formed cartilaginous tissue demonstrated resilence,
returning to its original configuration after bending. The cartilaginous structure of the
human outer ear is extremely complex and offers a significant challenge in reconstructive
surgery. In 1992, a soft nonwoven polymer mesh with 14-mm-diameter fibres (PLA, PGA
and PLGA) was formed into the shape of a human ear by using a silicone prosthetic ear as a
mould, and then the cell was seeded onto the ear-shaped structures and implanted on the
back of an athymic mouse [513]. Plastic and orthopaedic surgeons are often faced with
repair and reconstruction of tendon defects. In 1995, Cao et al. [514] seeded tenocytes onto
a strip of nonwoven PGA mesh and PGA fibres arranged in parallel with a knot at one end.
They found that the rate of the parallel arrangement of the tissue structures was enhanced
when longitudinal polymer fibres were used.
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Wells [515] has summarised the tests used in the USA for medical fabrics including wound
dressings. The requirements for medical devices were defined in The Medical Device
Amendment Act of 1976 [515]. Medical fabrics have been classified in three categories
as follows [515, 516].

Class I — Non-critical items requiring only general regulation to prevent, for example,
adulteration and misbranding. Usually the manufacturer can provide reasonable
assurance of safety and effectiveness. Examples of fabric products in Class I include
surgical sponges, dressings and examination gowns.
Class II — The nature of the device requires more than just general control. The device
should comply with established performance standards. Examples of fabric products in
Class II are surgical gowns, drapes and sterilisation wraps.
Class III — These products are intended for supporting or sustaining human life and/or
making products that do not have enough historical data to assure safe and effective
performance or present a potential for unreasonable risk of illness or injury. Pre-market
approval is required. Examples of fabric products in Class III include arterial grafts.

To meet government regulations and the requirements of product performance, all

wound dressings are tested to demonstrate safety and effectiveness and to develop an under-
standing of the conditions under which the products are to be used. The general profiles of
wound dressings subject to routine testing by the Surgical Material Testing Laboratory
(SMTL) in the UK are listed below. The SMTL is an authority on the testing of medical
disposables and dressings to British, European, and international standards [517].
Hydrocolloid Dressings [69]: Gelling characteristics, moisture-vapour transmission rate
(MVTR), fluid handling properties, conformability.
Alginates [286]: Gelling characteristics, fluid-handling properties.
Bandages [518]: Classification of bandages into performance groups, clinical evaluations.
Stockings [519, 520]: Compression profile measurement of compression hosiery.
Hydrogels: Fluid-handling properties, dehydration characteristics, stability studies on
medicated gels.
40 Textile Progress

6.1 Some Important Wound Dressing Standards (BP, ASTM and BS)
Many standards for dressings have been introduced by the American Society for Testing and
Materials (ASTM), The British Pharmacopoeia (BP), and British Standards Institution (BSI)
in recent years. BP [522] defined a series of test methods for surgical dressings including fibre
identification, yarn linear density, threads per stated length (unstretched, fully stretched),
weight per unit area (non-adhesive dressings, adhesive dressings, weight of adhesive mass),
minimum breaking load, elasticity, extensibility, adhesiveness, water-vapour permeability
(tapes, foam dressings), waterproofness, absorbency (sinking time, water-holding capacity),
water-soluble substances, ether-soluble substances, colour fastness, content of antiseptics,
content of zinc oxide in the adhesive mass, X-ray opacity, sulphated ash of surgical
dressings, and water-retention capacity. Other standards relevant to wound dressings
include sterility tests [523], microbial contamination tests [524], efficacy of antimicrobial
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preservation [525] and methods of sterilisation [526].

Methods of testing surgical dressings and surgical dressing materials have been defined in
ASTM2836.0–11(1998) as follows: general introduction and list of methods [527], methods
for the determination of loss of mass on drying [528], identification of cotton and viscose
fibres [529], determination of mass per unit area [530], determination of size [531], deter-
mination of sinking time [532], determination of absorption rate and water-holding
capacity [533], determination of level of surface-active substances [534], determination of
quantity of water-soluble substances [535], determination of the presence of starch and
dextrins [536], determination of the presence of fluorescing substances [537], determination
of sulphated ash content [538]. A new standard [539] for testing tissue-engineering medical
products has been introduced which addresses raw or virgin material characteristics in a
non-fabricated form that will ultimately undergo additional processing into growth,
support, or delivery vehicles for cells or biomolecules. The purpose of the guide is to assist
the developer of tissue-engineered medical products to locate relevant existing standards
and test methods and to provide guidance for interim use of materials for which a standard
does not exist.
In the British Standards, six methods have been established for wound dressings:
absorbency [540], moisture-vapour transmission rate [541], waterproofness [542], conform-
ability [543], bacterial barrier properties [544], and odour control [545]. Four more standards
have been defined for nonwovens used in medical devices and wound-care materials:
uncoated [546] and adhesive-coated [547] nonwoven medical-packaging materials, non-
woven fabrics used for manufacturing compresses [548] and finished nonwoven compresses
used in wound care [549]. Other standards related to medical fabrics include a specification
for spinal and abdominal fabric supports [550] and a specification for the elastic properties
of fabric bandages [551].

6.2 Standards for Nonwovens (INDA, ASTM, ISO and ERT)

Guidelines [554] and additional standard test methods for nonwovens which are relevant
to the wound-dressing function are given in the INDA (Association of the Nonwoven Fabrics
Industry) Standard Tests (IST) methods [552–554]. The test methods include liquid
absorption, abrasion resistance, bursting strength, electrostatic properties, binder properties,
optical properties, air permeability, and water-vapour transmission, repellency, stiffness,
tear strength, tensile, thickness, weight, friction, dry-cleaning, linting, fibre identification,
and degradability of nonwoven fabrics. The test methods for breaking strength [555] and
Nonwoven Wound Dressings 41

water-vapour transmission [556] in textile fabrics given by the ASTM are also valuable for
evaluating wound-dressing fabrics.
Standard test methods for nonwoven fabrics given by the ISO include: definition of
nonwovens [557], vocabulary of web formation and bonding in nonwovens [558],
determination of mass per unit area [559], determination of thickness [560], determination
of tensile strength and elongation [561], determination of tear resistance [562], absorption
[563], determination of bending length [564], determination of liquid strike-through time
(simulated urine) [565], and determination of drape coefficient [566].
Forty-four standard test methods have been established in the name of ERT (EDANA
Recommended Tests) by EDANA (European Disposables and Nonwovens Association)
[567]. Among them, thirty-one test methods are intended for nonwovens and twelve methods
for superabsorbent materials. The ERT testing methods not endorsed in the IST and ISO
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standards are listed as follows:

run-off [568], penetration (coverstock – wetback [569], wet barrier [570, 571], bacterial
filtration efficiency [572], bacterial penetration [573, 574]), and free formadehyde [575–578].
ERT standards for superabsorbent materials are as follows:
pH [579], residual monomers [580], particle size distribution [581], moisture content
[582], free swell capacity [583], centrifuge retention capacity [584], absorbency against
pressure [585], flow rate [586], density [587], extractables [588], respirable particles [589],
and dust [590].
Different test methods for nonwovens developed by the ASTM, INDA, TAPPI, AATCC,
EDANA, and ISO/CEN have been compared by INDA [591].

6.3 Some Major Standards for General Medical Devices Related to Wound
Dressings (ASTM, ISO and BS)
Some ASTM standard test methods for medical devices that are relevant to dressings relate
to general practice for medical devices [592, 593], analysis of medical materials [594–598],
methods for medical packages [599–601], methods for implant and tissue materials [602,
603], fluid penetration [604], and sterilisation and disinfection [605, 606].
The ISO standard test methods for devices relating to medical textiles and wound dressings
include: sterilisation [607–613], quality systems [614–616], clinical-investigation methods
[617] and risk management [618], and biological evaluation of medical devices [619–634].
Standard methods for determining human reaction to skin contact with hot surfaces [635],
medical bandages [636] and sterilisation are also given in the British Standards [637–639].

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[556] ASTM E96 — 66 (R72): Water-vapour transmission of materials in sheet form.
[557] ISO 9092:1988: Textiles — Nonwovens — definition.
[558] ISO 11224:1993: Textiles — Nonwovens — web formation and bonding — vocabulary.
[559] ISO 9073 — 1:1989: Textiles — Test methods for nonwovens — Part 1: Determination of mass per unit
[560] ISO 9073 — 2:1995: Textiles — Test methods for nonwovens — Part 2: Determination of thickness.
[561] ISO 9073 — 3:1989: Textiles — Test methods for nonwovens — Part 3: Determination of tensile strength
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and elongation.
[562] ISO 9073 — 4:1997: Textiles — Test methods for nonwovens — Part 4: Determination of tear resistance.
[563] ISO 9073 — 6:2000: Textiles — Test methods for nonwovens — Part 6: Absorption.
[564] ISO 9073 — 7:1995: Textiles — Test methods for nonwovens — Part 7: Determination of bending length.
[565] ISO 9073 — 8:1995: Textiles — Test methods for nonwovens — Part 8: Determination of liquid strike-
through time (simulated urine).
[566] ISO 9073 — 9:1995: Textiles — Test methods for nonwovens — Part 9: Determination of drape coefficient.
[567] Recommended Test Methods (ERT), EDANA, Brussels, Belgium, 1998.
[568] ERT 152.0 — 99: Run-off.
[569] ERT 151.2 — 99: Coverstock — wetback.
[570] ERT 160.0 — 89: Wet barrier — hydrostatic head.
[571] ERT 170.0 — 89: Wet barrier — Mason jar.
[572] ERT 180.0 — 89: Bacterial filtration efficiency.
[573] ERT 190.0 — 89: Dry bacterial penetration.
[574] ERT 200.0 — 89: Wet bacterial penetration — critical area.
[575] ERT 210.1 — 99: Free formadehyde — I.
[576] ERT 211.1 — 99: Free formaldehyde — II (under stressed conditions).
[577] ERT 212.0 — 96: Free formaldehyde — III (determination by HPLC).
[578] ERT 213.0 — 99: Free formaldehyde — IV (in processing).
[579] ERT 400.1 — 99: pH.
[580] ERT 410.1 — 99: Residual monomers.
[581] ERT 420.1 — 99: Particle size distribution.
[582] ERT 430.1 — 99: Moisture content.
[583] ERT 440.1 — 99: Free swell capacity.
[584] ERT 441.1 — 99: Centrifuge retention capacity.
[585] ERT 442.1 — 99: Absorbency against pressure.
[586] ERT 450.1 — 99: Flow rate.
[587] ERT 460.1 — 99: Density.
[588] ERT 470.1 — 99: Extractables.
[589] ERT 480.1 — 99: Respirable particles.
[590] ERT 490.1 — 99: Dust.
[591] Global Comparison of Test Methods, Association of the Nonwoven Fabrics Industry, Cary, NC, USA,
[592] ASTM D1898: Practice for sampling of plastics.
[593] ASTM F960 — 86 (2000). Standard specification for medical and surgical suction and drainage systems.
[594] ASTM F561 — 97: Practice for retrieval and analysis of implanted medical devices, and associated
[595] ASTM F619 — 79 (1997): Standard practice for extraction of medical plastics.
[596] ASTM F997 — 98a: Standard specification for polycarbonate resin for medical applications.
[597] ASTM F1251: Terminology relating to polymeric biomaterials in medical and surgical devices.
[598] ASTM F1855 — 00: Standard specification for polyoxymethylene (acetal) for medical applications.
[599] ASTM F1585 — 00: Standard guide for integrity testing of porous barrier medical packages.
[600] ASTM F1886 — 98: Standard test method for determining integrity of seals for medical packaging by
visual inspection.
[601] ASTM F1929 — 98: Standard test method for detecting seal leaks in porous medical packaging by dye
[602] ASTM F1854 — 98: Standard test method for stereological evaluation of porous coatings on medical
Nonwoven Wound Dressings 57

[603] ASTM F981: Practice for assessment of compatibility of biomaterials for surgical implants with respect
to effect of materials on muscle and bone.
[604] ASTM F1862 — 00a: Standard test method for resistance of medical face masks to penetration by
synthetic blood (horizontal projection of fixed volume at a known velocity).
[605] ASTM E1766 — 95: Standard test method for determination of effectiveness of sterilization processes
for reusable medical devices.
[606] ASTM E1837 — 96: Standard test method to determine efficacy of disinfection processes for reusable
medical devices (simulated use test).
[607] ISO 11607:1997: Packaging for terminally sterilized medical devices.
[608] ISO 11135:1994: Medical devices — Validation and routine control of ethylene oxide sterilization.
[609] ISO 11721 — 1:2001: Textiles — Determination of resistance of cellulose-containing textiles to micro-
organisms — soil burial test — Part 1: Assessment of rot-retardant finishing.
[610] ISO 11737 — 1:1995: Sterilization of medical devices — microbiological methods — Part 1: Estimation of
population of micro-organisms on products.
[611] ISO 11737 — 2:1998: Sterilization of medical devices — microbiological methods — Part 2: Tests of
sterility performed in the validation of a sterilization process.
[612] ISO 14160:1998: Sterilization of single-use medical devices incorporating materials of animal origin —
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validation and routine control of sterilization by liquid chemical sterilants.

[613] ISO 14937:2000: Sterilization of healthcare products — general requirements for characterization of a
sterilizing agent and the development, validation and routine control of a sterilization process for
medical devices.
[614] ISO 13485:1996: Quality systems — Medical devices — Particular requirements for the application of
ISO 9001.
[615] ISO 13488:1996: Quality systems — Medical devices — Particular requirements for the application of
ISO 9002.
[616] ISO 14969:1999: Quality systems — Medical devices — Guidance on the application of ISO 13485 and
ISO 13488.
[617] ISO 14155:1996: Clinical investigation of medical devices.
[618] ISO 14971:2000: Medical devices — Application of risk management to medical devices.
[619] ISO 10993 — 1:1997: Biological evaluation of medical devices — Part 1: Evaluation and testing.
[620] ISO 10993 — 2:1992: Biological evaluation of medical devices — Part 2: Animal welfare requirements.
[621] ISO 10993 — 3:1992: Biological evaluation of medical devices — Part 3: Tests for genotoxicity,
carcinogenicity and reproductive toxicity.
[622] ISO 10993 — 4:1992: Biological evaluation of medical devices — Part 4: Selection of tests for interactions
with blood.
[623] ISO 10993 — 5:1999: Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity.
[624] ISO 10993 — 6:1994: Biological evaluation of medical devices — Part 6: Tests for local effects after
[625] ISO 10993 — 7:1995: Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization
[626] ISO 10993 — 8:2000: Biological evaluation of medical devices — Part 8: Selection and qualification of
reference materials for biological tests.
[627] ISO 10993 — 9:1999: Biological evaluation of medical devices — Part 9: Framework for identification
and quantification of potential degradation products.
[628] ISO 10993 — 10:1995: Biological evaluation of medical devices — Part 10: Tests for irritation and
[629] ISO 10993 — 11:1993: Biological evaluation of medical devices — Part 11: Tests for systemic toxicity.
[630] ISO 10993 — 12:1996: Biological evaluation of medical devices — Part 12: Sample preparation and
reference materials.
[631] ISO 10993 — 13:1998: Biological evaluation of medical devices — Part 13: Identification and
quantification of degradation products from polymeric medical devices.
[632] ISO 10993 — 15:2000: Biological evaluation of medical devices — Part 15: Identification and
quantification of degradation products from metals and alloys.
[633] ISO 10993 — 16:1997: Biological evaluation of medical devices — Part 16: Toxicokinetic study design for
degradation products and leachables.
[634] ISO 14708 — 1:2000: Implants for surgery — Active implantable medical devices — Part 1: General
requirements for safety, for marking and for information to be provided by the manufacturer.
[635] PD 6504:1983: Medical information on human reaction to skin contact with hot surfaces.
[636] BS 7505:1995: Specification for the elastic properties of flat, non-adhesive, extensible fabric bandages.
[637] BS EN 1617:1997: Sterile drainage catheters and accessory devices for single use.
[638] BS EN 868 — 2:1999: Packaging materials and systems for medical devices which are to be sterilized —
Sterilization wrap: requirements and test methods.
[639] BS EN 1422:1998: Sterilizers for medical purposes — Ethylene oxide sterilizers: requirements and test