Small Bites Vs Large Bites Abdominal Midline Incisional Closure

NCT ID: NCT07154277

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-23
• Study Completion Date: 2025-12-24

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.

Conditions

Suture Techniques; Wound Closure Techniques; Laparotomy/Standerds; Surgical Wound Dehiscence; Incisional Hernia/Prevention and Control; Surgical Wound Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Large Bite Closure of midline laparotomy wound

Standard closure: Suture bite should be 1 cm away from wound margin and 1 cm apart from the previous suture bite

Group Type: ACTIVE_COMPARATOR

Large bite closure

Intervention Type: PROCEDURE

Large bite closure is defined as tissue bite of 1cm depth x 1 cm travel x 1cm apart, on the aponeurosis away from midline using Prolene 0

Small Bite Closure of midline laparotomy wound

Small Bite closure: Suture bite should be 0.5 cm away from wound margin and 0.5 cm apart from the previous suture bite

Group Type: EXPERIMENTAL

Small bite closure

Intervention Type: PROCEDURE

Small bite suturing is small tissue bite of 0.5cm depth x 0.5cm travel x 0.5cm apart, on the aponeurosis away from midline using Prolene 2/0

Interventions

Small bite closure

Small bite suturing is small tissue bite of 0.5cm depth x 0.5cm travel x 0.5cm apart, on the aponeurosis away from midline using Prolene 2/0

Intervention Type: PROCEDURE

Large bite closure

Large bite closure is defined as tissue bite of 1cm depth x 1 cm travel x 1cm apart, on the aponeurosis away from midline using Prolene 0

Intervention Type: PROCEDURE

Other Intervention Names

small bite suturing technique; small bite suture; 0.5*0.5*0.5 suturing technique; Large bite suturing technique; Large bite suture; Large suturing technique

Eligibility Criteria

Inclusion Criteria

• Adults ages in between 18-60 year old
• All emergency laparotomies (Except trauma)

Exclusion Criteria

• Previous surgery with midline incision
• Pregnancy
• Current immunosuppressive or chemotherapy
• Previous incisional hernia after midline incision

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dow University of Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Omer Bin Khalid Jamil

Role: PRINCIPAL_INVESTIGATOR

Ruth K.M. Pfau Civil Hospital Karachi

Locations

Dr. Ruth K. M. Pfau Civil Hospital Karachi

Karachi, Sindh, Pakistan

Countries

Pakistan

Other Identifiers

2888

Identifier Type: -

Identifier Source: org_study_id