Comparison of Outcome of Purse-string Versus Conventional Linear Wound Closure Techniques in Patients Undergoing Stoma Reversal

May 19, 2026 updated by: Dr. Sayed Elyas, Children Hospital Faisalabad
To compare outcomes of purse-string skin closure and conventional linear skin closure techniques in patients undergoing stoma reversal

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Upon receiving permission from the ERC, children who fulfill the operational definitions and inclusion criteria will be enrolled in the research after informed consent. Children of both genders, age 8 months to 12 years, undergoing ileostomy or colostomy reversal will be included. All patients will be divided into two groups by lottery method by offering them to pick up slip. In group A patients, skin wound closure after stoma reversal will be done with technique of purse-string closure. In group B patients, skin closure after reversal will be done with technique of conventional linear closure. All procedures will be performed by the same. Outcome of surgery will be noted in every patient of both groups as per operational definition. This all data will be recorded on a specially designed proforma

Study Type

Interventional

Enrollment (Estimated)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Faisalābad, Punjab Province, Pakistan, 38000
        • Children hospital Faisalabad
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children of both genders
  • 8 months to 12 years
  • Undergoing ileostomy or colostomy reversal will be include

Exclusion Criteria:

  • • Patients with Re-current stoma prolapse

    • Patients with Re-do stomas
    • Patients with underlying chronic inflammatory and neoplastic conditions (Tuberculosis, Maligency

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Purse-string closure group
Patients undergoing stoma reversal in whom wound closure will be performed using the purse-string closure technique.
Procedure: Purse-string wound closure
Closure of stoma reversal wound using purse-string approximation technique
Active Comparator: Conventional linear closure group
Patients undergoing stoma reversal in whom wound closure will be performed using the conventional linear closure technique
Procedure: Conventional linear wound closure
Closure of stoma reversal wound using conventional linear skin closure technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical Site Infections
Time Frame: 7 days
The presence of infection at the wound site, identified by clinical signs (e.g., redness, swelling, pus)
7 days
Time for wound healing
Time Frame: 6 weeks
The duration from the surgical procedure until the wound is fully healed. It will be assessed on clinical examination of wound closure, including inspection for signs of epithelialization and the absence of gaps or dehiscence.
6 weeks
Length of stay
Time Frame: 10 days
The total number of days a patient in a hospital from admission till discharge date.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children Hospital Faisalabad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

May 19, 2026

First Posted (Actual)

May 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 26, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • CH-FSD-RCT-2026-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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