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

August 27, 2026 updated by: Karmy Hany Farouk, Assiut University

Vacuum-Assisted Closure Versus Graduated Primary Skin Closure for the Management of Postoperative Burst Abdomen: A Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients aged 18 years or older of either sex
  • Clinically confirmed complete (full-thickness) postoperative burst abdomen following a midline or paramedian laparotomy
  • Medically fit to tolerate bedside wound management/re-intervention (hemodynamically stable, not requiring vasopressor support)
  • Patient or legal guardian willing and able to provide written informed consent

Exclusion Criteria:

  • Planned or pre-existing open abdomen (laparostomy) at the index operation
  • Presence of enterocutaneous or enteroatmospheric fistula at the wound site
  • Uncontrolled intra-abdominal sepsis or ongoing hemodynamic instability precluding safe wound management
  • Known hypersensitivity or allergy to polyurethane foam or adhesive drape materials used in VAC systems
  • Active malignancy with peritoneal carcinomatosis where wound closure is not a treatment priority
  • Pregnancy
  • Refusal to participate or to be randomized

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vacuum-Assisted Closure (VAC)
Participants in this arm receive negative pressure wound therapy (NPWT) using an open-cell polyurethane foam dressing, fenestrated adhesive drape, and continuous sub-atmospheric pressure standardized between -75 and -125 mmHg. A non-adherent protective layer is interposed over exposed bowel loops. Dressing changes and wound assessments are performed under aseptic technique every 48 to 72 hours until sufficient granulation tissue forms to permit secondary suturing or delayed primary closure.
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.
Active Comparator: Graduated Primary Skin Closure
Participants in this arm undergo bedside staged/graduated primary wound closure using full-thickness interrupted monofilament retention sutures with bolsters/bridges across the abdominal wall under local anesthesia. Sutures are progressively approximated and tightened in sequential sessions every 48 to 72 hours (mirroring the dressing change interval) to avoid tension-related tissue ischemia until complete fascial and skin apposition is achieved.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Complete Wound Closure
Time Frame: 30 days
Measured as the number of days elapsed from the date of randomization until complete fascial and skin apposition of the abdominal wound is achieved, verified by clinical examination.
30 days

Collaborators and Investigators

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

Sponsor

Assiut University

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)

October 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

August 27, 2026

First Submitted That Met QC Criteria

August 27, 2026

First Posted (Actual)

September 1, 2026

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAC vs Graduated Burst Closure

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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