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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssiut University

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Vacuum-Assisted Closure (VAC) Therapy

    Procedure/Surgery

    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.

  • Graduated Primary Skin Closure

    Procedure/Surgery

    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.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Vacuum-Assisted Closure (VAC)Experimental treatment 1 intervention
Group B: Graduated Primary Skin ClosureActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Time to Complete Wound Closure

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.

Time frame
30 days

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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