SUBMISSION OF SYNOPSIS

ON
A CLINICOBACTERIOLOGICAL STUDY ON
POST OPERATIVE SURGICAL SITE
INFECTION FOLLOWING EMERGENCY
SURGICAL PROCEDURE IN A RURAL
MEDICAL COLLEGE IN WEST BENGAL
BY
DR. BISWAJIT BARAI
M.S. PGT, GENERAL SURGERY
BANKURA SAMMILANI MEDICAL COLLEGE

GUIDE:

PROF. DR. RAM KRISHNA MONDAL

M.S., M.Ch (PAEDIATRIC SURGERY )
BANKURA SAMMILANI MEDICAL COLLEGE.

CO-GUIDE: PROF. DR. JAYANTA BIKASH DEY

M.D. (MICROBIOLOGY),
H.O.D , DEPARTMENT OF MICROBIOLOGY,
BANKURA SAMMILANI MEDICAL COLLEGE.

To,
The Chairperson,
Institutional Ethical Committee,
Bankura Sammilani Medical College & Hospital,
Bankura.
Subject: Application for Ethical Clearance Of Thesis
Respected Sir,
With due respect, I want to inform you that, I, Dr. Biswajit Barai, 1st year post
graduate trainee in the Department of General Surgery, am planning to do my thesis on the topic
of A CLINICOBACTERIOLOGICAL STUDY ON POST OPERATIVE SURGICAL SITE
INFECTION FOLLOWING EMERGENCY SURGICAL PROCEDURE IN A RURAL
MEDICAL COLLEGE IN WEST BENGAL as the requirement towards MS (General Surgery)
degree curriculum under West Bengal University of Health Sciences. My synopsis of proposal,
the patient consent forms, patient information form and undertaking letter are attatched herewith.
I will be highly obliged if you kindly review review my research proposal and give
your valuable clearance regarding the above mentioned proposal.
Thanking in anticipation,
Yours sincerely,
Date:

Dr. Biswajit Barai

Place:

PGT(General Surgery), BSMCH

Signature of Guide

Signature of Co-Guide

Signature of Head of the Department

UNDERTAKING OF INVESTIGATOR
I hereby declare that I, Dr. Biswajit Barai, M.S.(General Surgery) PGT(2014-2017
session) am doing the study entitled A CLINICOBACTERIOLOGICAL STUDY
ON POST OPERATIVE SURGICAL SITE INFECTION FOLLOWING
EMERGENCY SURGICAL PROCEDURE IN A RURAL MEDICAL COLLEGE
IN WEST BENGAL under the guidance and close supervision of Prof. Dr. Ram
Krishna Mondal, Professor, Department of General Surgery and Prof. Dr. Jayanta
Bikash Dey, Professor and H.O.D, Department of Microbiology, Bankura
Sammilani Medical College & Hospital, solely for the purpose of my thesis and
fulfilment of my MS course. I shall be liable to bring to the notice of the ethical
committee the development and adverses. The investigations will be done in the
Hospitals own setup and will be a routine one, putting no extra financial burden to
the patient.

Dr. Biswajit Barai

PGT, Dept. of General Surgery
Date:

Session 2014-2017

PATIENTS INFORMATION FORM

I, Dr. Biswajit Barai, PGT in the Department of General Surgery of this
institution (Bankura Sammilani Medical College & Hospital), am doing a
research work on the thesis topic A CLINICOBACTERIOLOGICAL STUDY
ON POST OPERATIVE SURGICAL SITE INFECTION FOLLOWING
EMERGENCY SURGICAL PROCEDURE IN A RURAL MEDICAL COLLEGE
IN WEST BENGAL under. Prof. Dr. Ram Krishna Mondal, Professor
(Department of General Surgery, BSMCH.) and Prof. Dr. Jayanta Bikash Dey,
Professor and H.O.D (Department of Microbiology, BSMCH.) hereby request you
to join in this study entitled above.
Here all the patients developing Surgical Site Infections after an emergency
surgical procedure in the Department of General Surgery are being included under
the study population.
You are free to participate in this study. Being a part of this study does not
essentially mean that your treatment protocol will get altered. The same
intervention will be offered to you as planned, only the documentation of the same
will be provided to me for the purpose of my thesis. No extra financial burden will
be posted on your shoulder, no unnecessary investigations will be enforced. All
you need to do is to co operate me with proper history, careful physical
examination and relevant investigations.
All the health related information provided to me will be kept confidential. After
analysis, if the result of the study be published in any article, under any
circumstances, your name and identity will not be disclosed. Your signed consent
form indicates that you decide to participate in the study.
(For an illiterate person I will make him/her understand the above-mentioned
in his/her own language).

SIGNED BY:

COUNTERSIGNED BY:
8

PATIENT CONSENT FORM

Name of the Study: A CLINICOBACTERIOLOGICAL STUDY ON POST OPERATIVE
SURGICAL SITE INFECTION FOLLOWING EMERGENCY SURGICAL PROCEDURE IN
A RURAL MEDICAL COLLEGE IN WEST BENGAL
By: Dr.Biswajit Barai, PGT, Department of General Surgery, BankuraSammilani Medical
College & Hospital, Bankura.
I, Mr./Ms. ...
C/O
Resident of
Aged.. years do hereby declare that, I have been informed about the above named study
and the nature and hazards of Surgical Site Infections. I am giving my consent voluntarily to
participate in this study with the understanding of my refusal to continue at any time during the
course of study shall not affect my right to receive treatment from the department concerned.

I do hereby declare that, I shall provide medical history of my illness, undergo clinical
examination, biochemical and Microbiological investigations and allow collection of necessary
clinical information including reports of my previous and future investigations or management if
any.
I have also been asked to contact Dr.Biswajit Barai, (PGT, Department of General Surgery) in
case of any emergency arising during the course of the study.

Name of Declarant

Name of Witness

Name of Investigator

Signature of Declarant

Signature of Witness

Signature of Investigator

Dated

Dated

Dated

THESIS TOPIC:

A CLINICOBACTERIOLOGICAL STUDY ON
POST OPERATIVE SURGICAL SITE
INFECTION FOLLOWING EMERGENCY
SURGICAL PROCEDURE IN A RURAL
MEDICAL COLLEGE IN WEST BENGAL

10

SUMMERY OF THE PROPOSAL:

Surgical site infection (SSI) continues to be a major source of morbidity following

operative procedures. Despite many decades of the application of refined surgical
techniques, environmental changes in the operating room and the use of preventive
antibiotics, infection at the surgical site remains a too common event.
Thus, in an era during which economic costs are a source of increasing concern in
surgery, SSIs prolongs hospitalization and increase many other costs that could be
avoided if infection had not occurred.
The objective of this study is to analyse and study the risk factors associated with
SSI, the understanding of which will help to prevent the occurance and help in
proper management of SSI and help in reducing the economic burden and
morbidity associated with it.
In this study, specifically those patients are being included who developed surgical
site infection after an emergency surgical interventon.

INCLUSION CRITERIA:
a) Patients developed wound infection after emergency surgery.
b) Patient given consent for the study

EXCLUSION CRITERIA:
a)
b)
c)
d)

OPD patients.
Elective surgery patients
Patient operated outside this institute
Not given consent for this study

11

AIMS AND OBJECTIVES:

BACKGROUND:

The occurance of infections in the post operative

wounds continues to be one of the serious complications from the times
immemorial. In the pre Lister era, approximately one and a half century ago, most
operative wounds became infected, leading to a feeling of helplessness among
surgeons in dealing with wound infection. The application of the principles of
antisepsis as developed through the works of Lister and Pasteur, paved the way for
the prevention of post operative infections in clean surgical wounds. The infection
rate in elective operations dropped from 90 % or more to 10% or less with the
application of Listerian Principles.
Though the post Listerian era is enriched with much more advances in the field of
asepsis and antiseptic techniques, surgical technique, newer antibiotics and modern
suture materials, surgical site infection is still a threat to the surgical world.
Another dilemma faced by the surgeons is the proper choice of antibiotics. The
indiscriminate use of antibiotics has led to the development of antimicrobial
resistance.Clear understanding of the pathogens and their pathogenicity with
judicious selection of antibiotics will help the surgeon in not only tackling this
problem, but will also turn out to be cost effective in long run .
The higher rates of surgical site infection are associated not only with a higher
morbidity and mortality but also with increased costs of medicare. Hence a
constant awareness of the ever present threat of infection must be a way of life for
the entire surgical fraternity.

12

SPECIFIC AIMS AND OBJECTIVES:

To study and analyse the determinants and risk factors associated with SSI.viz
1. Most common organism encountered and its antibiotic sensitivity and
resistance profile in surgical site infection (SSI).
2. Comorbid conditions associated with SSIs.
3. The different causal factors for SSI in emergency surgery in our
hospital set up.

13

 MATERIALS AND METHODS:

STUDY AREA:
Department of General Surgery, Bankura Sammilani Medical College
and Hospital, Bankura.

STUDY POPULATION:
Patients coming from various parts of Bankura and adjoining areas who
are admitted in the Department of General Surgery, Bankura Sammilani
Medical College and Hospital, Bankura and operated on for Emergency
Surgery.

STUDY PERIOD:
June 2015 to May 2016 (12 months).

SAMPLE SIZE:
At least 100 patients.

SAMPLE DESIGN:

STUDY DESIGN:

14

 PARAMETERS TO BE STUDIED:
Detailed history taking.
Thorough clinical examination with BMI
Biochemical examinations, including CBC, FBS/PPBS, LFT.
Microbiological investigations from wound swab including culture
and sensitivity
operative findings from operative note in BHT
Antibiotics received
Follow up of the cases.

STUDY TOOLS:
Opd ticket, Indoor ticket, biochemical, microbiological and radiological
reports, operative notes and treatment sheets, predesigned and pretested
structured questionnaire.

STUDY TECHNIQUE:
Consecutive 100 consenting patients (strictly following the inclusion
criteria) coming from various parts of Bankura and adjoining areas,
admitted during the prefixed one year duration in the department of
General Surgery, BSMC&H, developing Surgical Site Infections (SSIs)
following Emergency surgical procedure are included.They are evaluated
randomly and prospectively by clinical, biochemical, microbiological
and special investigations post. The total number of patients developing
SSIs and their outcome is assessed, and the causetive organisms, there
antibiotic sensitivity and resistance patterns, co-morbidities and the
relationship of developing SSIs with the type of emergency surgery
performed is determined.

PLAN FOR ANALYSIS OF DATA: Standard statistical analysis.

15

REVIEW OF LITERATURE
DEFINITIONS:
CRITERIA FOR DEFINING A SURGICAL SITE INFECTION (SSI):

The surgical wound infection task force, including representatives from the
Society for Hospital Epidemiology of America, the Association for Practitioners in
infection Control and the Surgical Infection Society, published in 1992, definitions
of surgical site infection. The term surgical wound was intentionally replaced with
surgical site to include infections arising after surgery that were in organ spaces,
deep to skin and soft tissue, such as peritoneum and bone.
Superficial incisional SSI:
Infection occurs within 30 days after the operation and infection involves only
skin or subcutaneous tissue of the incision and at least one of the following:
1. Purulent drainage, with or without laboratory confirmation, from the superficial
incision.
2. Organisms isolated from an aseptically obtained culture of fluid or tissue from
the superficial incision.
3. At least one of the following signs or symptoms of infection: pain or tenderness,
localized swelling, redness, or heat and superficial incision are deliberately opened
by surgeon, unless incision is culture-negative.
4. Diagnosis of superficial incisional SSI by the surgeon or attending physician
Deep incisional SSI:
Infection occurs within 30 days after the operation if no implant is left in
place or within 1 year if implant is in place and the infection appears to be related
to the operation and infection involves deep soft tissues (e.g., facial and muscle
layers) of the incision and at least one of the following:
1. Purulent drainage from the deep incision but not from the organ/space
component of the surgical site.
16

2. A deep incision spontaneously dehisces or is deliberately opened by a surgeon

when the patient has at least one of the following signs or symptoms: fever
(>38C), localized pain, or tenderness, unless site is culture-negative.
3. An abscess or other evidence of infection involving the deep incision is found on
direct examination, during reoperation, or by histopathologic or radiologic
examination.
4. Diagnosis of a deep incisional SSI by a surgeon or attending physician.
Organ/Space SSI:
Infection occurs within 30 days after the operation if no implant is left in place
or within 1 year if implant is in place and the infection appears to be related to the
operation and infection involves any part of the anatomy (e.g., organs or spaces),
other than the incision, which was opened or manipulated during an operation and
at least one of the following:
1. Purulent drainage from a drain that is placed through a stab wound into the
organ/space.
2. Organisms isolated from an aseptically obtained culture of fluid or tissue in the
organ/space.
3. An abscess or other evidence of infection involving the organ/space that is found
on direct examination, during reoperation, or by histopathologic or radiologic
examination.
4. Diagnosis of an organ/space SSI by a surgeon or attending physician.

17

18

BIBLIOGRAPHY

19

PROFORMA FOR PATIENT

Name :
DOA :

Age :

Sex :

DOS :

IP No. :
DOD :

Chief Complaints:
History:

Clinical Examinations:
Pulse:

B.M.I.:

B.P.:
Findings:
Diagnosis:
Operation:
1) Emergency
- Major
- Minor
2) Duration of surgery
3) Done By
- Unit chief
- Assistants
- PG students

Investigations:
Hb% :

FBS:

Urine sugar:

Blood Urea:

Serum proteins:

S Creatinine:

Chest x-ray :
USG Whole Abdomen:
20

RBS:

Other investigations:
1) PREOPERATIVE FINDINGS
a) Preoperative Bath
b) Skin preparation
Type: Shaving
Clipping
Depilatory Cream
c)Time of preparation
> 24 hours :
< 24 hours :
d) Preparation of bowel :
e) Preoperative antibiotics
- Immediate preoperative
- Intraoperative
e) Steroid medication

2) OPERATIVE FINDINGS
a) Type of Anaesthesia:
b) Wound Class:
c) Duration of Surgery:
d) Suture material
e) Wound irrigation
f) Drain

- Open
- Close

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3)POST OPERATIVE DETAILS

Antibiotic Used
A

Antibiotic
Duration of use

Inspection of wound
Post Op Day
(Hrs)

Tenderness

Swelling or
oedema

Local rise of
temperature

Redness

Discharge

48 Hrs
3rd
4th
5th
6th
7th

Culture report
Antibiotic to which sensitive
A

1
2
3
4

22