A Comparison of Incisional Negative-Pressure Wound Therapy Versus Conventional Dressings Following Abdominal Surgery

Study Overview
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Brief Summary
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The purpose of this study is to compare outcomes between incisional negative-pressure wound vacuum-assisted closure (VAC) therapy versus conventional dressings following abdominal surgery.

Detailed Description
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This study will prospectively compare rates of wound complications using incisional negative pressure wound therapy versus conventional dressings following abdominal reconstruction. Patients will undergo abdominal surgery (panniculectomy, abdominoplasty, ventral hernia repair, or autologous flap reconstruction using abdominal donor tissue). Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days. After this time, the wound will be assessed for signs of infection, seroma, hematoma, skin and fat necrosis, skin dehiscence, and hernia during the follow-up appointments.

Official Title
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A Comparison of Incisional Negative-Pressure Wound Therapy Versus Conventional Dressings Following Abdominal Surgery: A Randomized-Controlled Trial

Conditions
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Abdominal Reconstruction

Intervention / Treatment
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* Procedure: Vacuum-assisted closure (VAC) therapy
* Procedure: Gauze dressing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients included in this study are patients undergoing abdominal reconstruction, which includes panniculectomy, abdominoplasty, ventral hernia repair and patients undergoing autologous flap reconstruction using abdominal donor tissue. Exclusion Criteria: Patients will be excluded from study if they have an actively infected wound involving the incision, abdominal malignancy, a history of enteric fistula formation, or a bleeding disorder.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vacuum-assisted closure (VAC) therapy<br>Following closure of the incision, patients will have incisional vacuum-assisted closure (VAC) therapy performed. | Procedure: Vacuum-assisted closure (VAC) therapy<br>* Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days.<br>* Other names: Negative-pressure wound therapy (NPWT);|
| Active Comparator: Gauze dressing<br>Following closure of the incision, patients will either have a gauze dressing placed over the incision. | Procedure: Gauze dressing<br>* Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days.<br>* Other names: standard care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Operative Wound Complications | Post-operative wound complications (infection, seroma, hematoma, skin and fat necrosis, skin dehiscence, and hernia) will be assessed at 2 days for gauze patients and at 5 days for VAC patients. This outcome will be assessed based on the clinical examination by the surgeon following removal of the wound dressing. There is no defined assessment tool for this outcome as clinical observation is the standard in these procedures. | Between 2 and 5 days following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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abdominal reconstruction