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Completed

NCT Number: NCT07573423

Linear Versus Purse String Skin Closure at Loop Ileostomy Reversal.

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hayatabad Medical Complex

Peshawar, KPK, 25000, Pakistan

About this study

Loop ileostomy reversal is a commonly performed surgical procedure; however, it is associated with a considerable risk of postoperative complications, particularly surgical site infection (SSI). Reported SSI rates after stoma closure range from 4% to over 20%, making it one of the most frequent causes of postoperative morbidity. The development of SSI not only delays wound healing but also contributes to prolonged hospital stay, increased healthcare costs, and reduced patient satisfaction.

Multiple techniques for skin closure following ileostomy reversal have been described, with conventional linear closure and purse-string closure being the most widely practiced. Linear closure involves primary approximation of the wound edges, resulting in complete closure of the skin. In contrast, the purse-string technique leaves a small central opening that allows continuous drainage of wound exudate, which may reduce bacterial colonization and lower the risk of infection.

Previous studies have suggested that purse-string closure may be associated with lower SSI rates and improved cosmetic outcomes compared to linear closure. However, linear closure remains widely used due to its technical simplicity and shorter operative time. Despite available evidence, there is still variability in clinical practice, and further high-quality randomized controlled trials are needed to establish the optimal technique.

This randomized controlled trial was conducted at the Department of General Surgery, MTI-Hayatabad Medical Complex, Peshawar. A total of 252 patients meeting the inclusion criteria were enrolled and randomly allocated into two groups: linear skin closure (Group A) and purse-string skin closure (Group B). Block randomization was used to ensure balanced group allocation.

All patients underwent ileostomy reversal according to standardized surgical protocols. Preoperative optimization, including management of comorbid conditions such as diabetes mellitus and hypertension, was performed as per institutional guidelines. Postoperatively, patients were monitored during their hospital stay and followed up for 30 days to assess outcomes.

The primary outcome of the study was the frequency of surgical site infection within 30 days of surgery. Secondary outcomes included length of hospital stay and duration of surgery. Data were collected using a structured proforma and analyzed using appropriate statistical methods.

The aim of this study is to provide evidence on the comparative effectiveness of purse-string versus linear skin closure techniques in reducing postoperative complications following ileostomy reversal. The results are expected to support evidence-based surgical practice and improve patient outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Linear Skin Closure

Procedure

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

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.

Primary outcomes

  1. Surgical Site Infections Rate

    Time frame: Within 30 days after surgery

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

Secondary outcomes

  1. Length of Hospital Stay

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

    Duration of hospital stay measured in days from the date of surgery to discharge.

Sponsors and collaborators

Lead sponsor

Hayat Abad Medical Complex, Peshawar

Other Gov

Registry information

Official study title

Comparison of Efficacy Between Linear Versus Purse String Skin Closure at Loop Ileostomy Reversal. A Randomized Control Trial.

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
May 7, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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