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Vacuum-Assisted Closure Versus Graduated Primary Skin Closure for Postoperative Burst Abdomen

NCT07797868 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-09-01

No results posted yet for this study

Summary

Burst abdomen, or complete abdominal wound dehiscence, is a severe postoperative complication characterized by the separation of the musculo-aponeurotic layer of the abdominal wall. It leads to extended hospital stays, high treatment costs, and an increased risk of long-term incisional hernia. While negative pressure wound therapy using vacuum-assisted closure (VAC) is widely utilized, graduated (staged) primary skin closure remains a common, accessible bedside alternative. Direct randomized comparative evidence evaluating these two approaches for established burst abdomen is limited.

The main objective of this study is to compare the clinical effectiveness and safety of vacuum-assisted closure (VAC) versus graduated primary skin closure in the management of postoperative burst abdomen.

Participants will be randomly assigned (1:1) to one of two groups:

1. VAC Group: Patients will receive continuous negative pressure wound therapy (-75 to -125 mmHg) applied via a specialized polyurethane foam and adhesive dressing, with changes performed every 48 to 72 hours until sufficient granulation tissue forms for definitive closure.
2. Graduated Closure Group: Patients will undergo progressive re-approximation of the wound edges using full-thickness retention sutures placed under local anesthesia and tightened incrementally every 48 to 72 hours until complete closure is achieved.

The primary outcome of the study is the time to achieve complete fascial and cutaneous wound closure. Secondary outcomes include total length of hospital stay, incidence of surgical site infections, pain scores during procedures, wound recurrence, and incisional hernia formation during follow-up.

Conditions

  • Abdominal Wound Dehiscence
  • Burst Abdomen
  • Surgical Wound Dehiscence

Interventions

PROCEDURE

Vacuum-Assisted Closure (VAC) Therapy

Under aseptic technique, non-viable tissue is debrided and the wound irrigated with normal saline. An open-cell polyurethane foam is trimmed to fit the wound cavity (with a non-adherent protective layer over exposed bowel), sealed with an adhesive drape, and connected to continuous sub-atmospheric pressure (-75 to -125 mmHg). Dressing changes and assessments are conducted every 48 to 72 hours until sufficient granulation tissue permits definitive closure.

PROCEDURE

Graduated Primary Skin Closure

Full-thickness interrupted retention monofilament sutures with protective bolsters/bridges are placed across the abdominal wall under local anesthesia at the bedside. Sutures are progressively tightened and approximated in sequential sessions every 48 to 72 hours to minimize tissue ischemia and tension until complete fascial and cutaneous apposition is achieved.

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-10-31
Primary Completion
2027-10-31
Completion
2027-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07797868 on ClinicalTrials.gov