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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07797868
Enrollment
50
Registered
2026-09-01
Start date
2026-10-01
Completion date
2027-11-01
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burst Abdomen, Surgical Wound Dehiscence, Abdominal Wound Dehiscence

Keywords

Negative Pressure Wound Therapy, Vacuum-Assisted Closure, NPWT, Graduated Primary Skin Closure, Staged Closure, Abdominal Wall Defect, Postoperative Complications, Incisional Hernia

Brief 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.

Interventions

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.

PROCEDUREGraduated 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

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to Complete Wound Closure30 daysMeasured 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026