LINEAR VERSUS PURSE STRING SKIN CLOSURE AT LOOP ILEOSTOMY REVERSAL

NCT07573423 | Completed DMC

• 1 other identifier: HMC-QAD-RCT-3
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized controlled trial designed to compare two commonly used skin closure techniques-linear closure and purse-string closure-after loop ileostomy reversal surgery. Surgical site infection (SSI) is one of the most frequent complications following stoma closure, leading to increased patient discomfort, prolonged hospital stay, and higher healthcare costs. In this trial, eligible adult patients undergoing elective loop ileostomy reversal are randomly assigned to either linear skin closure or purse-string skin closure. The purse-string technique leaves a small central opening that allows drainage, which may reduce infection risk, whereas linear closure involves complete approximation of the wound edges. All patients are managed according to standard hospital protocols and are followed during their hospital stay and for 30 days after surgery. The primary outcome is the occurrence of surgical site infection. Secondary outcomes include length of hospital stay and operative time. The purpose of this study is to determine which closure technique provides better outcomes in terms of reducing postoperative infections and improving recovery. The findings may help guide surgeons in selecting the most effective and safe method for skin closure after ileostomy reversal.

Conditions

Surgical Site Infection (SSI); Ileostomy Closure; Surgical Technique Comparison

Keywords

Surgical Site Infections; Purse-string skin closure; Linear skin closure; Wound closure techniques; Postoperative complications; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infections Rate

  Proportion of participants who develop surgical site infection at the ileostomy reversal wound site, assessed using standard clinical criteria (redness, discharge, swelling, or pus).

  Within 30 days after surgery

Secondary Outcomes (1)

• Length of Hospital Stay

  From surgery until hospital discharge (up to 7 days after surgery)

Study Arms (2)

Linear Skin Closure

ACTIVE COMPARATOR

Participants undergoing loop ileostomy reversal receive conventional linear skin closure with primary approximation of wound edges.

Procedure: Purse-String Skin Closure

Purse-String Skin Closure

ACTIVE COMPARATOR

Participants undergoing loop ileostomy reversal receive purse-string skin closure, leaving a small central opening to allow drainage.

Procedure: Linear Skin Closure

Interventions

Linear Skin Closure PROCEDURE

Closure of the ileostomy reversal wound using conventional linear suturing with complete approximation of skin edges.

Purse-String Skin Closure

Purse-String Skin Closure PROCEDURE

Closure of the ileostomy reversal wound using purse-string suturing technique, leaving a central gap for drainage to reduce infection risk.

Linear Skin Closure

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 20 to 70 years
• Both male and female patients
• Patients undergoing elective loop ileostomy reversal
• American Society of Anesthesiologists (ASA) physical status I-II
• Patients who provide informed consent

You may not qualify if:

• Patients with active stoma site infection (e.g., fever with total leukocyte count \>11,000/mm³)
• Patients not planned for ileostomy reversal
• Patients with severe comorbid conditions (ASA III or above)
• Patients unwilling to participate in the study

Sponsors & Collaborators

• Hayat Abad Medical Complex, Peshawar: lead

Study Sites (1)

Hayatabad Medical Complex

Peshawar, KPK, 25000, Pakistan

Location

Related Publications (4)

• Ameer A, Mirza MB, Talat N. The Outcome of Purse-string Versus Conventional Wound Closure Techniques in Patients Undergoing Stoma Reversal: A Randomized Controlled Trial. J Pediatr Surg. 2024 Jun;59(6):1186-1189. doi: 10.1016/j.jpedsurg.2023.10.062. Epub 2023 Oct 30.

  PMID: 37978002 RESULT

• O'Leary DP, Carter M, Wijewardene D, Burton M, Waldron D, Condon E, Coffey JC, Peirce C. The effect of purse-string approximation versus linear approximation of ileostomy reversal wounds on morbidity rates and patient satisfaction: the 'STOMA' trial. Tech Coloproctol. 2017 Nov;21(11):863-868. doi: 10.1007/s10151-017-1713-x. Epub 2017 Nov 17.

  PMID: 29149428 RESULT

• Aga E, Keinan-Boker L, Eithan A, Mais T, Rabinovich A, Nassar F. Surgical site infections after abdominal surgery: incidence and risk factors. A prospective cohort study. Infect Dis (Lond). 2015;47(11):761-7. doi: 10.3109/23744235.2015.1055587. Epub 2015 Jun 26.

  PMID: 26114986 RESULT

• Nota SP, Braun Y, Ring D, Schwab JH. Incidence of surgical site infection after spine surgery: what is the impact of the definition of infection? Clin Orthop Relat Res. 2015 May;473(5):1612-9. doi: 10.1007/s11999-014-3933-y.

  PMID: 25212963 RESULT

MeSH Terms

Conditions

Surgical Wound Infection; Postoperative Complications

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open-label study in which neither participants nor care providers are blinded due to the nature of the surgical interventions. Outcome assessment is based on objective clinical criteria.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgeon Registrar

Model Details: Participants are randomly assigned in a 1:1 ratio to either linear skin closure (Group A) or purse-string skin closure (Group B) following loop ileostomy reversal. Both groups are followed prospectively to compare postoperative outcomes.

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 7, 2026
• Study Start: June 22, 2020
• Primary Completion: July 1, 2025
• Study Completion: July 31, 2025
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)