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Not Yet Recruiting NCT07797868

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

Conditions: Abdominal Wound Dehiscence, Burst Abdomen, Surgical Wound Dehiscence

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Assiut University

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.

Eligibility Criteria

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07797868). StuddyBuddy aggregates publicly available trial information.