Compare Stoma Reversal Wound Outcomes Between NPWT and Secondary Intention Healing

NCT07258134 | Completed DMC

• 1 other identifier: SIUT-ERC-2025/A-275
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This was a single-center, parallel-group randomized controlled trial conducted in 2024 at the General Surgery Ward of the Sindh Institute of Urology and Transplantation (SIUT), Karachi. The study compared negative pressure wound therapy (NPWT) with healing by secondary intention (SIH) for patients undergoing stoma reversal surgery.

Conditions

Negative-Pressure Wound Therapy; Wound Heal; Stoma Site Infection; Surgical Site Infection

Keywords

Negative pressure wound therapy; secondary intention Healing; Surgical site infection; asepsis score

Outcome Measures

Primary Outcomes (1)

• Highest Postoperative Asepsis Score for SSI assessment

  The primary outcome was the occurrence and severity of surgical site infection, assessed using the ASEPSIS scoring system (Additional treatment, Serous discharge, Erythema, Purulent exudate, Separation of deep tissues, Isolation of bacteria, and Stay duration as an inpatient) on postoperative days 2, 4, and 6. The highest ASEPSIS score recorded across these time points was used for between-group comparison. The score may vary between. 0-70 with higher score representing worse outcome.

  Post-operative day (POD) 2, 4 and 6 (ASEPSIS score recorded)

Secondary Outcomes (2)

• Scar Cosmesis Assessment and Rating (SCAR) score on postoperative day 30

  On Postoperative day 30 wound cosmesis were assessed using scar scale

• Length of Stay

  6-12 days. Following completion of study observations on postoperative day 6, patient may be discharged on meeting the discharge criteria. Expected between 6-12 days.

Study Arms (2)

Negative pressure wound therapy

EXPERIMENTAL

In the NPWT (negative-pressure wound therapy) group, after the procedure, the skin was left open and covered with four sterile gauze layers. An 18 Fr Nelaton catheter was placed directly over the wound and sealed with transparent, waterproof adhesive to create a vacuum. Continuous negative pressure was applied at 15 mmHg. Dressings were evaluated for Surgical site infection on postoperative days 2 and 4 using the ASEPSIS score; if no infection was present, a NPWT dressing was reapplied. On postoperative day 6, a final wound assessment was conducted, and further management was carried out as per departmental protocol.

Procedure: Negative Pressure Wound Therapy

secondary intention healing

NO INTERVENTION

In the SIH (secondary intention healing) group, the wound was left open and dressed using four layers of sterile gauze and a transparent adhesive dressing. Similar to the NPWT group, dressing changes and assessments using the ASEPSIS score were performed on postoperative days 2, 4, and 6. If an infection was identified, standard management protocols were followed.

Interventions

Negative Pressure Wound Therapy PROCEDURE

In the NPWT (negative pressure wound therapy) group, after the procedure, the skin was left open and covered with four sterile gauze layers. An 18 Fr Nelaton catheter was placed directly over the wound and sealed with transparent, waterproof adhesive to create a vacuum. Continuous negative pressure was applied at 15 mmHg. Dressings were evaluated for SSI on postoperative days 2 and 4 using the ASEPSIS score; if no infection was present, NPWT dressing was reapplied. On postoperative day 6, final wound assessment was conducted and further management was carried out as per departmental protocol.

Negative pressure wound therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients with history of prolonged antibiotic use prior to stoma reversal surgery (\>1months).
• Patients with prior skin condition that required medical treatment (for instance, Plaque Psoriasis).
• Patient with prior history of wound-related complication (like keloids or hypertrophic scars).
• Furthermore, after allocation, the patients with the following protocol violations were also excluded:
• Patients who had undergone any other forms of wound closure after stoma reversal, that deviated from the study protocol.
• Patients who were re-operated during the hospital stay for any other reason than surgical site infection.

Sponsors & Collaborators

• Sindh Institute of Urology and Transplantation: lead

Study Sites (1)

Sindh Institute of Urology and Transplantation

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Conditions

Surgical Wound Infection

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 23, 2025
• First Posted: December 2, 2025
• Study Start: February 24, 2025
• Primary Completion: August 30, 2025
• Study Completion: August 30, 2025
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

PA (1)