Small Bites Vs Large Bites Abdominal Midline Incisional Closure

NCT07154277 | Active Not Recruiting Phase 2 DMC

• 1 other identifier: 2888
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

midline abdominal closure; emergency laparotomy; small bite closure; large bite closure; wound closure

Outcome Measures

Primary Outcomes (2)

• Number of participants with Wound Dehiscence

  Wound dehiscence as seen by the surgeon.

  1 month

• Number of participants with Surgical Site Infections

  As per CDC guidelines and seen by the surgeon

  1 month

Study Arms (2)

Large Bite Closure of midline laparotomy wound

ACTIVE COMPARATOR

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

Procedure: Large bite closure

Small Bite Closure of midline laparotomy wound

EXPERIMENTAL

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

Procedure: Small bite closure

Interventions

Small bite closure 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

Also known as: small bite suturing technique, small bite suture, 0.5*0.5*0.5 suturing technique

Small Bite Closure of midline laparotomy wound

Large bite closure 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

Also known as: Large bite suturing technique, Large bite suture, Large suturing technique

Large Bite Closure of midline laparotomy wound

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dr. Ruth K. M. Pfau Civil Hospital Karachi

Karachi, Sindh, 74400, Pakistan

Location

MeSH Terms

Conditions

Surgical Wound Dehiscence; Incisional Hernia; Surgical Wound Infection

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hernia; Pathological Conditions, Anatomical; Wound Infection; Infections

Study Officials

• Omer Bin Khalid Jamil

  Ruth K.M. Pfau Civil Hospital Karachi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Masking is done only for outcome assessor as it is not possible for others to be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients are randomly categorized into two different groups and treated differently and outcomes are assessed in the same manner in both groups.

Study Record Dates

• First Submitted: July 12, 2024
• First Posted: September 4, 2025
• Study Start: November 23, 2023
• Primary Completion: December 24, 2025
• Study Completion: December 24, 2025
• Last Updated: September 4, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)