Does placement of an extra negative suction drain prevent surgical site infection in abdominal surgery – a randomized control trial.
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/11/060099
- Lead Sponsor
- Dr Anurakshat Gupta
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 106
All patients undergoing abdominal surgeries at a tertiary care teaching hospital.
- (a)Patients undergoing inguinal hernia surgery.
- (b)Patients unwilling to be a participant of the study.
- (c)Patients below 18 years of age.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method in abdominal surgeries reduces the occurrence of SSIs, by comparing their 3 days after surgery | 7days after surgery | 10days after surgery wounds with the control group on the 3 days after surgery, 7days after surgery and 10days after surgery based on Southampton 3 days after surgery | 7days after surgery | 10days after surgery wound grading system. 3 days after surgery | 7days after surgery | 10days after surgery To determine if the use of additional negative suction drain 3 days after surgery | 7days after surgery | 10days after surgery
- Secondary Outcome Measures
Name Time Method To identify if the same is related to decreased post operative pain score assessed by Visual Analogue Scale (VAS) and reduced
Trial Locations
- Locations (1)
Command Hospital (SC)
🇮🇳Pune, MAHARASHTRA, India
Command Hospital (SC)🇮🇳Pune, MAHARASHTRA, IndiaDr Anurag RoyPrincipal investigator7798729859anuragroy47@gmail.com