A correlation of placement of additional subcutaneous negative suction drain with occurrence of surgical site infection in any abdominal surgery – a randomized control trial.

INTRODUCTION

Surgical site infection (SS), carlier known as post-operative wound infection is defined as the infection

presenting within 30 days after a surgiecal procedure if no implants are placed or up to one year if an

implantable device was placed in the patient.

Ssls are a major complication of surgery. Collection of blood and/or serous fluids in subcutaneous

spaces which later gets infected becomes a predisposing factor for SSI in abdominal surgeries. Though

the global estimates of SSls have varied from 0.5% to 15%, studies in India have consistently shown

higher rates ranging from 23% to 38%Bl Prevention of the risk of infection is, therefore, a profitable

concept for surgery that must be integrated within all healthcare managements worldwide and more so

in the developing economies like ours.

RESEARCH QUESTION

Does placement of an additional subcutaneous negative suction drain in abdominal surgeries has any

benefit in prevention of SSIs in patients undergoing abdominal surgeries from Aug 2022 to July 2024?

HYPOTHESIS Placement of additional subcutaneous negative suction drain in abdominal surgeries reduces SSI

ALTERNATE HYPOTHESIS Placement of additional subcutaneous negative suction drain in abdominal surgeries has no significant

effect on SSI

REVIEW OF LITERATURE

Surgical site infection (SSI), earlier known as post-operative wound infection is defined as the infection

presenting within 30 days after a surgical procedure if no implants are placed or up to one year if an

implantable device was placed in the patient.

SSIs are a major complication of surgery. Collection of blood and/or serous fluids in subcutaneous

spaces which later gets infected becomes a predisposing factor for SSI in abdominal surgeries.) Though

the global estimates of SSIs have varied from 0.5% to 15%, studies in India have consistently shown

higher rates ranging from 23% to 38%

The risk of developing SSI is multifactorial and includes patient factors like advanced age. immunocompromised

state, poor nutrition, chronic illness, etc. The environmental factors that add to the occurrence

of SSIs includes breach in sterlity during operative procedures, length of surgery, hypothermia,

etc. The degree of microbial contamination in the operated site is proportional to the nature of surgery

and is indicated by wound class as clean, clean- contaminated, contaminated, and dirty wound.4

SSls causes significant discomfort to the patient with excess morbidity and mortality and is a financial

burden on the healthcare system. The magnitude of burden of SSls extends from increased risk of sepsis

and death, prolonged hospital stays, emotional liability. distress to the family, to over utilization of hospital

resources, increased workload on hospital staff and overall economic and social loss.S

In 2017, the Centers for Disease Control and Prevention (CDC) guidelines evaluated the mean cost

caused by SSI treatment to be from $ 10,443 to S 25,546 per SSI 6

AIM

The aim of our study is to determine if placement of an additional subcutaneous negative

suction drain in abdominal surgeries has any benefit in prevention of SSls.

OBJECTIVES

(a) Primary Objective - To determine if the use of additional negative suction drain

in abdominal surgeries reduces the occurrence of SSIs, by comparing their

wounds with the control group on the 3", 7th and 10h day based on Southampton

wound grading system.

(6) Secondary Objective - To identify if the same is related to decreased post

operative pain score assessed by Visual Analogue Scale (VAS) and reduced

length of hospital stay.

STUDY DESIGN

An RCT conducted at the tertiary care hospital/medical college in Westerm Maharashtra

SITE OF STUDY

Dept of Surgery, AFMC Pune

Command Hospital Southern Command Pune

SOURCE POPULATION

All patients undergoing abdominal surgeries at a tertiary care teaching hospital.The study population

will cover serving soldiers, entitled dependents and civilian patients entitled for treatment

at AFMC Pune and CH(SC).

STUDY TYPE

RCT

INCLUSION CRITERIA

All patients undergoing abdominal surgeries at a tertiary care teaching hospital.

EXCLUSION CRITERIA

) Patients undergoing inguinal hernia surgery

b) Patients unwilling to be a participant of the study.

(cPatients below 18 years of age.

SAMPLE SIZE

n-106 (53 in each am)

Totest

HO: mln2

Where nl and n2 are infection rales in intervention group and control tively, with group respec

a-5%

Power= 80%

(Infection rate in intervention group) 24%

T2 50% infection rate in control group)

The minimum required sample size is 53 in each group. Total sample size = 106 patients

53 patients in each arm (Control group and Study group)

Study group: Patients with additional subcutaneous negative suction drain. Control

group: Patients with no additional subcutaneous negative suction drain.

DURATION OF STUDY

The study will be carried for a period of 3 months after approval

METHODOLOGY

In the study group, the abdominal wound will be closed over a negative suction subcutaneous drain.

Patients will be followed up daily till post-operative day 10 and the status of the wound will be recorded

on post-operative days 3, 7 and 10 based on Southampton wound grading system. The negat1ve

suction drain will be removed on post operative day 5. SSI cases will be diagnosed within 30 days

from the date of surgery by the CDC criteria.

COLLECTION OF DATA

Pre-structured and validated performa for Data collection will be used (Appendix A)

Data will be entered in excel sheet and compiled.

PRIMARY END POINT

In the study group, the abdominal wound will be closed over a negative suction subeutaneous drain.

Patients will be followed up daily till post-operative day 10 and the status of the wound will be recorded

on post-operative days 3.7 and 10 based on Southampton wound grading system. The negative

suction drain will be removed on post operative day 5. SSI cases will be diagnosed within 30 days

from the date of surgery by the CDC criteria

COST ESTIMATION

There wil be no financial implications for this study

FEASIBILITY OF STUDY

Feasible