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

Not Applicable

Withdrawn

• Conditions: Abdominal Reconstruction
• Interventions: Procedure: Vacuum-assisted closure (VAC) therapy; Procedure: Gauze dressing

• Registration Number: NCT02534116
• Lead Sponsor: Yale University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2015-08-13
• Study First Submitted QC: 2015-08-24
• Study First Posted: 2015-08-27
• Study Start: 2015-12
• Primary Completion: 2016-10
• Study Completion: 2017-04
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-11
• Last Update Posted: 2018-01-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vacuum-assisted closure (VAC) therapy	Vacuum-assisted closure (VAC) therapy	Following closure of the incision, patients will have incisional vacuum-assisted closure (VAC) therapy performed.
Gauze dressing	Gauze dressing	Following closure of the incision, patients will either have a gauze dressing placed over the incision.

Primary Outcome Measures

Name	Time	Method
Post Operative Wound Complications	Between 2 and 5 days following surgery	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.

Trial Locations

Locations (1)

Yale University, Section of Plastic Surgery; 🇺🇸 New Haven, Connecticut, United States