An interventional study of Negative Pressure Wound Therapy and Direct Skin Closure in Burst Abdomen, Surgical Wound Dehiscence and Abdominal Wound Dehiscence, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Alexandria University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn whether negative pressure wound therapy (NPWT, also called vacuum-assisted closure) works better than direct skin closure for treating burst abdomen in adults. Burst abdomen is a serious complication of abdominal surgery in which the layers of the abdominal wall separate after the operation.
The main question it aims to answer is:
- Does NPWT increase the number of patients whose abdominal wall muscle layer (fascia) can be fully closed?
Researchers also compared the two treatments for pressure inside the abdomen, length of hospital stay, time and number of sessions needed to close the wound, wound infection, bowel fistula, incisional hernia, need for another operation, and death.
Participants with burst abdomen after elective or emergency abdominal surgery were randomly assigned to one of two treatments:
Participants were followed in hospital and then seen in the outpatient clinic 1 month and 3 months after treatment.
Background Burst abdomen (postoperative abdominal wound dehiscence) is partial or complete separation of the abdominal wall layers after laparotomy, sometimes with exposure or protrusion of the bowel. It is more common after emergency surgery and in patients with sepsis, malnutrition, anaemia, smoking or raised intra-abdominal pressure. It is associated with prolonged hospitalization, high morbidity and mortality, and later incisional hernia. Direct skin closure is a simple and inexpensive way to cover the viscera but does not restore fascial continuity. Negative pressure wound therapy removes exudate, reduces tissue oedema, promotes granulation tissue and may allow progressive fascial approximation. Randomized evidence comparing the two approaches in burst abdomen is limited.
Setting Gastrointestinal Surgery Unit, Alexandria Main University Hospital, Faculty of Medicine, Alexandria University, Egypt. The study was conducted as a Master's degree thesis in Surgery.
Baseline assessment History (demographics, medical, surgical and drug history), physical examination including ASA physical status and defect size, complete blood count and serum albumin, and CT of the abdomen and pelvis.
Randomization Computer-generated allocation using the REDCap randomization module, stratified by sex, age (40 years or younger vs. older than 40) and ASA score (3 or less vs. more than 3).
Interventions All procedures were performed under general anaesthesia with endotracheal intubation in the supine position, with perioperative antibiotics and povidone-iodine skin preparation.
NPWT arm: exposed bowel was protected with silicone sheets. Sterile open-cell polyurethane foam (pore size 400-600 micrometres) was cut to fill the wound and contact all margins, sealed with occlusive adhesive film, and connected to an adjustable suction pump. Continuous negative pressure was started at 50 mmHg and increased over about 10 minutes to a maximum of 75 mmHg according to tolerance. Suction was stopped 30-60 minutes before each change. Foam and dressing were changed every 3 days in the operating room until definitive aponeurotic closure.
Direct skin closure arm: the skin was closed with interrupted polypropylene (Prolene) 0 sutures at equal intervals. A standard dressing was changed every other day. Sutures were removed aseptically under local anaesthesia at day 14 if healing was complete.
Measurements Intra-abdominal pressure was measured indirectly as urinary bladder pressure through a Foley catheter connected to a saline-filled system. Intraoperative data included operative time, additional procedures (diversion, debridement, drains), intraoperative complications, residual defect dimensions, peak airway pressure and use of silicone sheet or mesh. Postoperative data included complications, device-related problems, daily urine output, central venous pressure, serum urea and creatinine, and length of hospital stay.
Statistical analysis Analysis was performed with IBM SPSS Statistics 25. Categorical variables were compared with the chi-square or Fisher's exact test and continuous variables with the independent t-test or Mann-Whitney U test, according to distribution. A two-sided p-value below 0.05 was considered significant.
48 studies on the registry are indexed under Surgical Wound Dehiscence; 14 are open to participants now.
This study's enrollment of 45 is below the median of 78 across 37 interventional studies indexed under Surgical Wound Dehiscence.
Browse Surgical Wound Dehiscence studies →Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants with burst abdomen managed with negative pressure wound therapy (vacuum-assisted closure). Exposed bowel was protected with silicone sheets, open-cell polyurethane foam was placed in the wound and sealed with adhesive film, and continuous suction was applied starting at 50 mmHg and increased to a maximum of 75 mmHg. Dressings were changed every 3 days in the operating room until definitive fascial closure.
Device: Negative Pressure Wound Therapy
Participants with burst abdomen managed with direct skin closure. The skin edges were approximated over the fascial defect with interrupted polypropylene 0 sutures. Dressings were changed every other day and sutures were removed at day 14 if healing was complete.
Procedure: Direct Skin Closure
Under general anaesthesia, silicone sheets were placed over exposed bowel, sterile open-cell polyurethane foam (pore size 400-600 micrometres) was cut to fill the wound, and the wound was sealed with occlusive adhesive film and connected to an adjustable suction pump. Continuous negative pressure was started at 50 mmHg and increased over about 10 minutes to a maximum of 75 mmHg as tolerated. Foam and dressing were changed every 3 days in the operating room until definitive aponeurotic closure.
Also known as: NPWT, Vacuum-Assisted Closure
Under general anaesthesia, the skin edges were closed over the abdominal wall defect with interrupted polypropylene (Prolene) 0 sutures at equal intervals. A standard wound dressing was applied and changed every other day. Sutures were removed aseptically under local anaesthesia at day 14 if healing was complete.
Definitive Aponeurotic (Fascial) Closure
Proportion of participants in whom complete closure of the abdominal wall fascia (aponeurosis) was achieved, assessed clinically.
Time frame: Up to 3 months after the index procedure
Intra-Abdominal Pressure
Intra-abdominal pressure in mmHg, measured indirectly as urinary bladder pressure through a Foley catheter connected to a saline-filled monitoring system.
Time frame: At the first, second and third postoperative measurement sessions (within the first week after the index procedure)
Number of Sessions to Definitive Closure
Number of dressing or operative sessions required until definitive fascial closure.
Time frame: up to 3 months
Time to Definitive Closure
Time in days from the index procedure to definitive fascial closure
Time frame: Up to 3 months
Length of Hospital Stay
Number of days from the index procedure to hospital discharge
Time frame: From the index procedure until discharge, up to 3 month
Surgical Site Infection
Proportion of participants with surgical site infection, diagnosed clinically.
Time frame: Up to 3 months
Enteroatmospheric or Enterocutaneous Fistul
Proportion of participants who develop an enteroatmospheric or enterocutaneous fistula.
Time frame: Up to 3 months
Unplanned Reoperation
Proportion of participants requiring an unplanned return to the operating room for a complication.
Time frame: Up to 3 months
Abdominal Compartment Syndrome
Proportion of participants who develop abdominal compartment syndrome, defined as sustained intra-abdominal pressure above 20 mmHg with new organ dysfunction.
Time frame: From the index procedure until discharge, up to 3 months
Intraoperative Complications
Proportion of participants with intraoperative complications such as bleeding or visceral injury during the index procedure.
Time frame: During the index procedure
Readmission
Proportion of participants readmitted to hospital after discharge.
Time frame: Up to 3 months
All-Cause Mortality
Proportion of participants who die from any cause.
Time frame: Up to 3 months
Plan to share: Yes — De-identified individual participant data underlying the results reported in the publication will be made available by the corresponding author upon reasonable request.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Beginning after publication of the main results, with no end date.
Access criteria: Requests from qualified researchers with a methodologically sound proposal should be sent to the corresponding author. Data will be shared after approval of the proposal and signing of a data access agreement.
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