Small Bites Vs Large Bites Abdominal Midline Incisional Closure
- Conditions
- Suture TechniquesSurgical Wound DehiscenceWound Closure TechniquesLaparotomy/StanderdsIncisional Hernia/Prevention and ControlSurgical Wound Infection
- Registration Number
- NCT07154277
- Lead Sponsor
- Dow University of Health Sciences
- Brief Summary
The goal of this trial is to compare the effectiveness of small bite versus large bite abdominal incision closure in emergency settings. It will also evaluate the safety and outcomes of each technique. The main questions it aims to answer are:
Does small bite closure reduce the incidence of superficial surgical site infections (SSI), wound dehiscence, and incisional hernia compared to large bite closure? What are the associated complications of each closure technique?
Participants will:
Undergo either a small bite or large bite abdominal incision closure during emergency laparotomy Visit the clinic for follow-up assessments at 7 days, 15 days, 1 month, 3 months, and 6 months post-operatively Have their wound healing and complications documented and analyzed during respective visits.
- Detailed Description
Background Wound site complications continue to be a major detrimental factor in surgical healthcare around the globe and are a major concern for general surgeons due to the associated morbidity and mortality. Superficial Surgical Site Infection (SSI) is defined as an infection related to a surgical procedure that occurs near the surgical site within 30 days following surgery (or up to 90 days following surgery where an implant is involved). The incidence of such complications is generally higher in emergency laparotomies compared to elective cases. Surgical technique plays a key role in the integrity of the post-operative wound, and among the numerous factors that influence wound healing, it is the only one under the direct control of the surgeon. The midline incision is the most commonly used surgical incision for emergency laparotomy as it provides quick, wide exposure and avoids damage to nerves, muscles, and the blood supply of the abdominal wall. Closure of the midline wound has traditionally been performed using a mass fashion or large bite technique with a running suture, but recently a new technique of small bite closure has been proposed.
Hypothesis The hypothesis is that small bite closure will have better outcomes than large bite closure in terms of reducing acute wound failure.
Objective This study aims to compare the effectiveness of small bite abdominal incision closure with large bite closure in patients undergoing emergency laparotomy at a tertiary hospital in Karachi, Pakistan.
Materials and Methods
A single-blinded randomized comparative trial will be conducted at Civil Hospital, a tertiary hospital in Karachi, Pakistan. A total of 200 participants will be recruited for this study, with equal participants divided into two groups. Patients undergoing emergency laparotomies will be randomly assigned to one of two groups:
Group A: Participants will undergo large bite closure. Group B: Participants will undergo small bite closure. Participants will be followed up at 7 days, 15 days, 1 month, 3 months, and 6 months postoperatively to assess for complications. Data collection will be done using a single-blinded, block randomization method, where each participant will be assigned a unique code.
Operational Definitions Effectiveness: Defined by the incidence of superficial SSI, wound dehiscence, and incisional hernia in the two study groups.
Superficial SSI: An infection near the surgical site within 30 days of surgery (or up to 90 days with an implant) involving only skin or subcutaneous tissue. Diagnosed by purulent drainage, isolated organisms from an aseptically obtained culture, or symptoms like pain, tenderness, localized swelling, redness, heat, and diagnosis by a surgeon or attending physician.
Wound Dehiscence: Partial or total separation of previously approximated wound edges due to failed wound healing.
Incisional Hernia: An abnormal protrusion of abdominal contents through the weakness in the abdominal wall at the incision site.
Large Bite Closure: Tissue bite of 1cm depth, 1cm travel, and 1cm apart, using Prolene 0.
Small Bite Closure: Tissue bite of 0.5cm depth, 0.5cm travel, and 0.5cm apart, using Prolene 2/0.
Jenkin's Rule: A 4:1 suture to wound ratio. Data Collection and Analysis Data will be collected through a structured Performa and analyzed using the latest version of SPSS. The analysis will focus on comparing the incidence of superficial SSI, wound dehiscence, and incisional hernia between the two groups, providing insights into the effectiveness of each closure technique.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 200
- Adults ages in between 18-60 year old
- All emergency laparotomies (Except trauma)
- Previous surgery with midline incision
- Pregnancy
- Current immunosuppressive or chemotherapy
- Previous incisional hernia after midline incision
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of participants with Wound Dehiscence 1 month Wound dehiscence as seen by the surgeon.
Number of participants with Surgical Site Infections 1 month As per CDC guidelines and seen by the surgeon
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Dr. Ruth K. M. Pfau Civil Hospital Karachi
🇵🇰Karachi, Sindh, Pakistan
Dr. Ruth K. M. Pfau Civil Hospital Karachi🇵🇰Karachi, Sindh, Pakistan