ORBIT

2018, VOL. 37, NO. 2, 140–144

https://doi.org/10.1080/01676830.2017.1383463

CLINICAL RESEARCH

The intraoperative use of polydioxanone foil to reduce the risk of sino-orbital

fistula formation in orbital exenteration
Aws Al-Hity, Maria Elena Gregory, and Ewan G Kemp
Tennent Institute of Ophthalmology, Gartnavel General Hospital, Glasgow, UK

ABSTRACT ARTICLE HISTORY

Background: Orbital exenteration is a radical surgical procedure resulting in deformity. It involves Received 17 December 2016
removal of the globe, optic nerve, extra-ocular muscles, orbital fat, lacrimal gland, and peri- Revised 12 May 2017
osteum. Sino-orbital fistula (SOF) formation is a common documented post-operative complica- Accepted 19 September 2017
tion, usually connecting the orbit and the ethmoid sinus. SOFs can cause leaks of serous fluid, and KEYWORDS
act as an entry site for pathogens into the orbit leading to socket infection and breakdown. Exenteration; fistula; orbit;
Methods: This retrospective study analyzed exenterations performed over a 22-year period PDS; polydioxanone
(1993—2015) at the National Ocular Oncology Service Centre for Scotland. PDS is a crystalline,
biodegradable polyether-ester that is strong with good shape-memory and flexibility. Orbital
exenterations with and without the use of PDS foil were compared in terms of SOF formation.
Results: A total of 30 exenterations were performed during the study period. A total of 29 were
analyzed. Choroidal malignant melanoma was the most common indication for performing orbital
exenteration (n = 7, 24.14%). The most common post-operative complications seen were SOF
(n = 8, 27.59%). A total of 8 out 21 (38.10%) cases not using PDS developed SOFs. By contrast,
none of nine patients receiving PDS plates developed SOFs (p = 0.0332).
Conclusions: This is the first study to compare SOF rate in patients undergoing exenteration with
and without the use of PDS foil. PDS foil is a safe material, which has effectively reduced the
incidence of SOF formation

Introduction rhinoplasty as the perforations allow tissue to granulate and

embed until the graft is completely resorbed. The foil has
Orbital exenteration is a disfiguring surgery. It is
been manufactured by Ethicon Inc (Johnson & Johnson
mostly performed for advanced neoplasms of the eye,
Inc, New Brunswick, New Jersey) to assist in reconstruction
often a last resort when previous, more conservative
of the orbit. The thinner foils (particularly ZX5 and ZX7)
therapy has failed.1 Secondary goals of orbital exentera-
are most suited for septal reconstruction, and the thicker
tion include: Detecting recurrent disease, restoring ana-
foils are primarily used for orbital floor surgery.5 PDS foil is
tomical boundaries of the orbit, and providing a
most commonly utilized in the manufacture of sutures,
satisfactory aesthetic outcome.2
which lose half their mechanical strength by 3 weeks in
Sino-orbital fistula (SOF) formation is a well-docu-
vivo and are hydrolyzed completely by approximately
mented post-operative complication, usually connect-
6 months.5,7
ing the orbit and the ethmoid sinus.3,4 SOFs occur
We propose that the same splinting and supporting
chiefly due to failure of complete granulation of the
properties of PDS foil could be applied to line the medial
orbit after lining and allowing for healing. SOFs can
wall of the orbit in order to prevent SOF formation. The
cause leaks of serous fluid and act as an entry site for
aim of our study is to investigate the use of PDS foil in
pathogens into the orbit leading to socket infection and
orbital exenteration and its impact on SOF formation.
breakdown.3 The treatment of SOF can be conservative,
medical or surgical involving flaps.
Polydioxanone (PDS) foil is a readily available, safe, Materials and methods
cheap, and tough absorbable material. It has been shown
This retrospective study analyzed exenterations per-
to display abilities to scaffold and regenerate cartilage and
formed over a 22-year period (1993—2015) at the
connective tissue in reconstructions of the nasal septum.5,6
National Ocular Oncology Centre for Scotland (Tennent
It is used widely in ENT surgery to support nasal cartilage in

CONTACT Aws Al-Hity alhitya@gmail.com Tennent Institute of Ophthalmology, Gartnavel General Hospital, 1053 Great Western Road, G12 0YN.
Color versions of one or more of the figures in the article can be found online at www.tandfonline.com/iorb.
© 2018 Taylor & Francis
 ORBIT 141

Institute of Ophthalmology, Gartnavel General Hospital, Table 1. Diagnosis.

Glasgow, Scotland, U.K.). The study was completed in Number of
Diagnosis cases Percentage
accordance with the declaration of Helsinki.
Adnexal tumours (cutaneous and 9 31.03
Prior to December 2009, all our orbital exenteration conjunctival melanomas)
procedures used the standardized technique without Choroidal melanoma with extra-scleral 7 24.14
spread
PDS foil. From 2010 onwards, the technique was aug- Squamous cell carcinoma 4 13.79
mented with PDS foil, which was cut into an oval shape Basal cell carcinoma 3 10.34
Sebaceous gland carcinoma 2 6.90
and positioned to cover the anterior half of the medial Muco-epidermoid tumour 1 3.45
orbital wall (the most common site of SOF formation) Rhabdomyosarcoma 1 3.45
Undifferentiated tumour 1 3.45
(see Figure 2B). The type of PDS foil utilized in this
study was the ZX8 by Ethicon Inc (Johnson & Johnson
Inc, New Brunswick, New Jersey). irretrievable thus 29 were available for analysis. The
Healing by secondary intention involved lining the male to female ratio was 1:1. The median age at exen-
socket with oxidized cellulose dressing, and packing with teration was 76 years (range: 6–87 years). Patients were
either Sodium Carboxy-methylcellulose Aquacel ribbon followed up from the time of surgery for a mean of
(manufactured by ConvaTec Inc, Greensboro, North 26 months (range: 2–110 months).
Carolina), Silver impregnated dressings or manuka
honey-coated dressings depending on the healing response.
The orbital packing was replaced every 2 days until granu- Diagnoses
lation was complete. Other methods of healing included eye
Table 1 lists the diagnoses as confirmed by pathology.
lid skin or split skin grafts. All the operations were carried
out by the same consultant ophthalmologist (E.G.K).
In order to compare both groups (PDS vs non-PDS), Previous therapy
data collection comprised of patient demographics, diag-
nosis, previous treatments, operative details, post-operative The majority of eyes in the study received therapy
complications, healing methods and follow-up. Sources of previous to the exenteration. A total of 20/29
data included the Scottish National Ocular Oncology data- (68.97%) had at least one form of therapy including
base, patient case records and pathology reports. cryotherapy, radiotherapy,and chemotherapy or enu-
The primary outcome measure was the incidence of cleation. The remaining nine (31.03%) had no pre-
SOF formation in both PDS and non-PDS groups. The vious therapy. Ten orbits (34.48%) had only one
data were statistically analyzed for significance using previous treatment with four (13.79%) receiving a
the two-tail fisher exact test. total of three separate treatments before listing for
exenteration (see Figure 1).

Results
Operative details
Patient demographics
A lid-sparing exenteration was performed in 16
A total of 30 exenterations were performed during the patients. The most common method of healing was
study period (1993–2014) One case record was secondary intention (n = 14, 48.28%) (see Table 2).

Figure 1. Therapy previous to exenteration. 1A – Types of therapy 1B – Patients receiving multiple previous therapies.
142 A. AL-HITY ET AL.

Table 2. A look at healing methods, previous treatment and The majority of patients (20/29, 68.97%) underwent
Sino-orbital fistula (SOF) formation between Polydioxanone some form of therapy prior to their exenteration
(PDS) and non-PDS group. Abbreviations: En (enucleation), CR (Table 2). Of those, fiv (25.00%) went on to develop
(cryotherapy), RT (radiotherapy), MMC (mitomycin), Ex (exci-
sion). Healing methods and previous treatments in PDS and a SOF.
Non-PDS group.
Non-PDS group PDS group
Discussions
Previous Previous
ID treatment Healing SOF ID treatment Healing SOF The most common underlying pathology necessitating
1 En Granulation Yes 1 RT + Ex + Granulation No exenteration in this study was malignant melanoma
MMC
2 None Split skin No 2 None Granulation No (conjunctival and choroidal). Several studies have
3 Ex Split skin No 3 MMC Granulation No
4 None Spared skin No 4 CR + Ex + Spared skin No
reported higher incidences of basal and squamous cell
MMC carcinomas as a diagnosis.1,8,9 Exenterations were total
5 None Granulation Yes 5 RT Split skin No
6 Ex + CR + Split skin No 6 Ex + MMC Granulation No
in 13 (44.83%) and lid-sparing in 16 (55.17%). This
MMC compares favourably with large-scale retrospective
7 None Spared skin No 7 RT + Ex Split skin No case note reviews, where total exenterations are per-
8 CR Granulation Yes 8 En Spared skin No
9 None Granulation No 9 CR + MMC Granulation No formed in 55% of cases, as reported by Gulnap et al.10
10 None Granulation Yes
11 Ex Split skin Yes The preferred healing method in our cases was via
12 Ex + CR + Spared skin Yes secondary intention (socket granulation), seen in
MMC
13 CR MMC Spared skin No 55.60% of patients. Gulnap et al also reported high
14 RT Granulation Yes proportions of sockets healing by granulation tissue
15 RT + MMC Spared skin No KEY
16 None Split skin No RT Radiotherapy (94.9%). The latter may be explained by virtue of sec-
17 None Split skin Yes EX Excision ondary intention healing offering good cosmesis in
18 MMC Granulation No EN Enucleation
19 MMC Granulation No MMC Mitomycin C these patients, the majority of which would not receive
20 Ex + MMC Granulation No CR Cryotherapy prostheses.10 A total of 20/29 (68.97%) of cases had pre-
treatment. This is slightly higher than is reported in the
literature where a 13-year retrospective case note
PDS vs non-PDS review by Rahman et al reported 31/68 (45.59%) cases
receiving treatment prior to undergoing exenteration.11
PDS foil was utilized in nine (31.03%) patients. Of
The SOF rate in our study was calculated at 27.59%.
those, five (55.56%) were left to heal by secondary
A study reported a 23.10% incidence of socket fistula
intention. The mean time to complete socket granula-
formation.12 SOF is multi-factorial in aetiology and
tion in all patients was 13 weeks (range: 9 – 39 weeks).
causes considerable patient discomfort. It also has the
potential to cause recurrent socket infection, which can
be problematic to manage. This study investigates the
Post-operative complications
rate of SOF in patients undergoing exenteration with
The most common post-operative complication was and without the use of PDS foil. It has been suggested
SOF formation, which occurred in 27.59% (8/29). All that fistula formation is the result of direct mechanical
eight patients were in the non-PDS group. The mean breach of bone at the time of surgery.13 The thinnest
time to fistula formation was 4.9 months post opera- walls of the orbit are the Lamina papyracea (covering
tively (range: 1–9 months). In total, five out of the eight the ethmoid sinuses along the medial wall), and the
(62.50%) SOF cases occurred in sockets left to heal by maxillary bone, particularly in its postero-medial por-
secondary intention (Table 2). In our study, all nine tion. This, combined with the longer healing time
exenterations performed with PDS foil did not develop needed for granulation by secondary intention, may
SOFs. A two-tail fisher exact test performed on the data account for the greater cases of fistula formation
demonstrates this result is significant (p = 0.0332). In observed in patients, where the socket was left to heal
comparison, of the 20 exenterations performed without by secondary intention (Table 2). There appears to be
PDS,and eight (40%) were developed SOFs. no correlation between SOF rate and previous treat-
Other post-operative complications included: ment as the majority of patients underwent treatment
socket infection (n = 7, 24.14%), socket haemorrhage of some kind prior to exenteration. There also seems to
(n = 1, 3.45%), failed split skin graft (n = 1, 3.45%), be no direct correlation between socket infections and
and recurrence of tumour (n = 1, 3.45%). Of the development of SOFs and fistula development seems,
seven socket infections, only three of them went on most likely, a result of a combination of different
develop SOFs. mechanisms.

Figure 2. Photographs taken during a case of orbital exenteration. 2A – the lids are sacrificed. 2B – shows the perforated
Polydioxanone (PDS) foil. 2C – shows the placement of the PDS foil on the medial wall of the orbit. 2D – shows the packing of
the socket. 2E – shows partial resorption of PDS foil at 2 weeks following surgery. 2F – shows post-operative complete socket
granulation.
Most of our patients chose not to obtain orbital
prostheses long-term following exenteration. This ten-
dency has been observed in other studies. It is for this
reason that the surgeon favoured healing by granula-
tion (Figure 2B). However, sockets left to granulate take
longer to heal than those lined by skin.12–15 The mean
time to complete socket granulation in our patients was
13 weeks (range 9–39 weeks). Chronic ethmoidal socket
fistulae developed most frequently (5/8, 62.50%) in
sockets left to heal by granulation, but did not pose
any difficulties for the patients (Table 1).
Orbital exenteration is a disfiguring surgery. It can
result in devastating functional, aesthetic and psycho-
logical losses. Although all patients in our study
received psychological assessments pre- and post-
exenteration, no quantitative data were obtained
regarding the impact of exenteration on quality of
life or the psychosocial impact of exenteration. Few
studies have reported on the psycho-social challenges
of patients following orbital exenteration. One study
reported on ten cases of orbital exenteration a total of
6 months post operatively. They found that although
all patients were satisfied with the medical results of
the surgery, 50% felt strongly uncomfortable or dis-
satisfied with the cosmetic effect of surgery. A further
60% declared that they were uncomfortable in the
company of friends and close relations. . It was
ORBIT 143
suggested that a counselling plan for patients is indi-
cated particularly to look into ways to improve their
cosmesis.16
At present, there are no previous reports of using
PDS foil during orbital exenteration to prevent SOF
formation. In the study, all nine exenterations per-
formed with PDS foil did not develop SOFs
(p = 0.0332). Absorbable graft materials have the poten-
tial to provide a scaffold for autologous tissue in the
early postoperative period (Figure 2B). By degrading
with time (and ideally without localized inflammatory
reaction), long-term complications of infection and
extrusion are avoided (Figure 2E).6
PDS is a crystalline, biodegradable polyether-ester
that is strong, with good shape-memory and flexibil-
ity. Animal models have demonstrated that PDS foil
is biodegradable by 25 weeks, leaving minimal
fibrous scar tissue. Insertion of the foil may even
stimulate cartilage regrowth and promote healing.7
The favorable performance of implants in these con-
texts has prompted the application of polydioxanone
foils as lining to the medial orbital wall to prevent
SOFs, although this study explored the use of PDS
foil in the context of orbital exenteration. No known
complications relating to the use of PDS foil have
been reported in the literature and this was reflected
in our study.
144 A. AL-HITY ET AL.
Conclusion
PDS foil is a safe material, which has effectively and
significantly reduced the incidence of SOF formation
following exenteration in our study, although greater
numbers are needed to further support the case for
its use.
Disclosure statement
The authors report no conflicts of interest. The authors alone
are responsible for the content and writing of the article.
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