Submission of Synopsis

8/10/2019 Submission of Synopsis

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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.


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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, 1styear 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 RURALMEDICAL COLLEGE IN WEST BENGALas 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


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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 theHospitals 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


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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. Allyou 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-mentionedin his/her own language).

SIGNED BY: COUNTERSIGNED BY:


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PATIENT CONSENT FORM

Name of the Study: A CLINICOBACTERIOLOGICAL STUDY ON POST OPERATIVE

SURGICAL SITE INFECTION FOLLOWING EMERGENCY SURGICAL PROCEDURE INA 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 ofSurgical 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 Microbiologicalinvestigationsand 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


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THESIS TOPIC:

A CLINICOBACTERIOLOGICAL STUDY ON

POST OPERATIVE SURGICAL SITE

INFECTION FOLLOWING EMERGENCY

SURGICAL PROCEDURE IN A RURAL

MEDICAL COLLEGE IN WEST BENGAL


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SUMMERY OF THE PROPOSAL:

Surgical site infection (SSI) continues to be a major source of morbidity followingoperative 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 withSSI, 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) OPD patients.

b)

Elective surgery patientsc)

Patient operated outside this institute

d)Not given consent for this study


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AIMS AND OBJECTIVES:

BACKGROUND: The occurance of infections in the post operative

wounds continues to be one of the serious complications from the timesimmemorial. 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.


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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 andresistance 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.


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MATERIALS AND METHODS:

STUDY AREA:

Department of General Surgery, Bankura Sammilani Medical Collegeand 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:


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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.


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

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 placeor 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 andat 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 radiologicexamination.

4. Diagnosis of an organ/space SSI by a surgeon or attending physician.


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BIBLIOGRAPHY


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PROFORMA FOR PATIENT

Name : Age : Sex : IP No. :

DOA : DOS : 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: RBS:

Urine sugar: Blood Urea:

Serum proteins: S Creatinine:

Chest x-ray :

USG Whole Abdomen:


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Other investigations:

1) PREOPERATIVE FINDINGS

a) Preoperative Bath

b) Skin preparation

Type: Shaving

ClippingDepilatory 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 B C D

Antibiotic

Duration of use

Inspection of wound

Post Op Day

(Hrs)

Tenderness Swelling or

oedema

Local rise of

temperature

Redness Discharge

48 Hrs

3rd

4

t

5t

6th

7t

Culture report

Antibiotic to which sensitive

A B C D

1

2

3

4

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Submission of Synopsis