From Chennai

Dr.M.S.Viswanathan, 9.7.2018
Assistant professor,
ESIC Medical College & Hospital,
K.K.nagar,
Chennai.
To
The Chairman,
Institutional Ethical Committee (IEC),
ESIC Medical College & Hospital ,
Chennai.
Through – Proper Channel

Respected Sir/ Madam,

Sub: Request to get approval from Ethical Committee for the research proposal –Reg.

As I have proposed to work on “A study on the effect of subcutaneous pullout 48

hours drain on surgical site wound healing, in a tertiary care hospital scenario”, I request
for an approval from the Ethical Committee, as this project involves human subjects. I am
enclosing the details of the project work along with this.

I submit the following undertakings:

 I will get the detailed informed consent from the patient or participant and
maintain confidentiality
 I will carry out the work without being detrimental to regular activities as well as without
causing extra expenditure to this Govt institution.
 I will inform the committee in case of any change in the study procedure, size,
investigator or guide.
 I will not deviate from the area of work for which I have applied for ethical clearance.
 I will inform the institutional ethical committee in case of any adverse events or serious
adverse reactions.
 I will abide by the rules and regulations of the institution.
 I will complete the work within the specified period and if any extension of time is
required I shall apply for the permission again to do the work.
 I will not claim funds from the institution while doing the work or on completion.
 I understand that the members of IEC have the right to monitor the work with prior
intimation.

Thanking you
Yours sincerely,

(DR.M.S.Viswanathan)
 A study on the effect of subcutaneous pullout 48
hours drain on surgical site wound healing, in a
Title
tertiary care hospital scenario

Aims and objectives 1.To study the effectiveness of subcutaneous pullout

drains in surgical site wound healing
2. To study the various outcomes of subcutaneous
pullout 48 hrs drains on surgical site wounds

Design of the study Prospective interventional study

Ethical Clearance Applied

Material or Selection of subjects 100 consented patients ,who are undergoing various
specific emergency & elective surgical procedures

Methods Subcutaneous drains will be placed in patients

undergoing various specific surgical procedures.

Outcome of the drains will be observed and rcorded

Analysis Collected data will be analyzed statistically.

Conflict of interest Nil

Financial support Nil

Primary Investigator Dr.M.S.Viswanathan

Assistant Professor
ESIC Medical College & Hospital
K.K.nagar
Chennai

Supervisor & Guide

 A study on the effect of subcutaneous pullout 48 hours drain on surgical site
wound healing, in a tertiary care hospital scenario

Primary Investigator:

Dr.M.S.Viswanathan
Assistant Professor
ESIC Medical College & Hospital
K.K.nagar
Chennai

Supervisor & Guide:

INTRODUCTION:

Surgical site infections (SSIs) are defined as wound infection following an invasive
surgical procedure. They constitute about 20 % of nosocomial infections, ranking as 3rd most
frequently reported nosocomial infections1. The prevalence rate of SSIs among various cities in
India ranges from 2.5% to 41.9% 2,3 .

SSIs remain as a substantial problem for patients undergoing procedures in spite of

advances in surgical techniques and medical care. Also SSIs are associated with increased
hospital stay and increased morbidity alongside increasing unnecessary patient suffering and a
decreased quality of life

Various interventions have been proposed to reduce SSIs, of which subcutaneous pullout
drains play a significant role in reducing SSIs and in promoting wound healing .The intention is
placing subcutaneous drains is to decompress or drain either fluid or air from the area of surgery,
to prevent accumulation of fluid like blood, pus etc.., to prevent accumulation of dead space and
to characterize fluid 4

This study is aimed to identify the efficacy and outcomes of subcutaneous pullout 48 hrs
drains on various specific emergency and elective surgical procedures in a tertiary care setup
AIMS & OBJECTIVES:
1. To study the effectiveness of subcutaneous pullout drains in surgical site wound healing
2. To study the various outcomes of subcutaneous pullout 48 hrs drains

MATERIALS & METHODS:

Study design:
 Prospective interventional study

Study population:
50 consented patients, undergoing various surgical procedures, of which 25 serves as
control group, in whom no drains are kept and the other 25 serves as test group, where
subcutaneous drains are kept and observed
Study setting:
Department of General Surgery, ESIC Medical College & Hospital, Chennai.

Inclusion criteria:
1. Patients undergoing various specific elective & emergency surgical procedures
2. Patients > 18 yrs of age

Exclusion criteria:
1. Patients < 18 yrs of age
2. Patients who are with known immunocompromised states

Methodology:

The study will be conducted after getting ethical committee approval, in which 50
consecutive consented patients undergoing various elective & emergency surgical procedures
,under Department of General surgery ,ESIC Medical college & Hospital ,will be included as
study population .Within the study population ,25 cases serves as control group and 25 cases
serves as test group .
Demographic details, personal history, use of any antimicrobial agents, ASA physical
status, type and duration of surgery, clinical evaluation of surgical site wound will be recorded in
a data sheet .Patients will be explained about the procedure and informed consent will be
obtained from them.
Following the specific surgical procedure, the wound will be irrigated with 2000 ml of
saline solution just before skin closure. The fascia/muscle layer will be closed by continuous
loop ethilon and the skin was closed by 3-0 ethilon. There will be no differences in the surgical
procedures between the control and test groups, except that a suction drain was inserted along the
entire length of the subcutaneous tissue only among the test group. The exit of the drain was
separated from the incisions. The outcomes of the drain like hematoma, wound healing, seroma,
abscess, and infection will be identified documented and will be managed accordingly.
The results of the study will be analyzed statistically

References:

1. NICE. Clinical Guideline 74—prevention and treatment of surgical site infection. NICE,
October 2008,http://www.nice.org.uk/nicemedia/pdf/CG74NICEguideline.pdf
2. Lilani SP, Jangale N, Chowdhary A, Daver GB. Surgical site infection in clean and clean-
contaminated cases. Indian J Medical Microbiology 2005; 23(4):249-252.

3. Surgical Site Infections: Incidence And Risk Factors In A Tertiary Care Hospital,
Western India Patel Sachin M1, Patel Mitesh H2, Patel Sangeeta D3, Soni Sumeeta T4,
Kinariwala Dipa M3, Vegad Mahendra M5 . National Journal of Community Medicine
Vol 3 Issue 2 April-June 2012. Page 193- Page 196

4. Tsujinaka S,Kawamura YJ,Konishi F ,et al ; Pelvic drainage for anterior resection

revisited:use of drains in anastomotic leaks.ANZ J Surg .2008;Jun 78(6):461-5
 PROFORMA

 Name : IP no:

 Age: Ward:

 Sex:

 Occupation:

 Address:

Presenting complaints:

Past history:

Personal history:

Associated immunocompromised state:

Any other associated risk factors:

Physical examination:
Provisional diagnosis:

Laboratory evaluation:

ASA physical status evaluation:

Type and duration of surgery:

Type of subcutaneous drain placed:

Outcome of the subcutaneous pullout 48 hrs drain:

 CONSENT FORM

STUDY TITLE:

“A study on the effect of subcutaneous pullout 48 hours drain on surgical site

wound healing, in a tertiary care hospital scenario”

I…………………………………………, hereby give consent to participate in the study

conducted by Dr.M.S.Viswanathan, Assistant Professor ,ESIC Medical College & Hospital,
Chennai and to use my personal clinical data and the result of investigations for the purpose of
analysis and to study the nature of the disease. I also give consent to place subcutaneous pullout
drain / not to place subcutaneous pullout drain following my surgical procedure. I also learn that
there is no additional risk in this study. I also give my consent for my investigator to publish the
data in any forum or journal

Signature/ Thumb impression Place:

of the patient/ relative Date:
Patient Name & Address:

Signature of the investigator:

Signature of the guide:

 INFORMATION SHEET
TITLE:

“A study on the effect of subcutaneous pullout 48 hours drain on surgical site

wound healing, in a tertiary care hospital scenario”
INVESTIGATOR:

Dr.M.S.Viswanathan
Assistant Professor
ESIC Medical College & Hospital
K.K.nagar
Chennai

GUIDE:

Following any emergency or elective surgeries ,surgical site infections are more common
and account for increased hospital stay ,economic loss ,increased morbidity , and decreased
quality of life .Many techniques have been used to reduce the incidence of this surgical site
infections .One of them is the placement of subcutaneous pullout drains ,which has been
documented to reduce substantially surgical site infection and promote wound healing .

Hence adequate knowledge of the efficacy of this subcutaneous drain in various surgical
procedures has to be identified, to properly manage the patients and to reduce the complications.
Iam going to do a study where the efficacy of these subcutaneous pullout drains in wound
healing and the various other outcomes will be identified and managed. Patients are included in
this study only after getting informed consent only.

This study is entirely voluntary and patient can withdraw any time from this study.
Extra cost will not be incurred to the patients in this study. Any doubt regarding this study will
be willingly clarified. Results of the study will be published. In case of any doubt please contact
Dr. M.S.Viswanathan, Cell: 9444419087.