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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-04-30

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.

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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.

Conditions

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Abdominal Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Vacuum-assisted closure (VAC) therapy

Following closure of the incision, patients will have incisional vacuum-assisted closure (VAC) therapy performed.

Group Type EXPERIMENTAL

Vacuum-assisted closure (VAC) therapy

Intervention Type PROCEDURE

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.

Gauze dressing

Following closure of the incision, patients will either have a gauze dressing placed over the incision.

Group Type ACTIVE_COMPARATOR

Gauze dressing

Intervention Type PROCEDURE

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.

Interventions

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Vacuum-assisted closure (VAC) therapy

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.

Intervention Type PROCEDURE

Gauze dressing

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.

Intervention Type PROCEDURE

Other Intervention Names

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Negative-pressure wound therapy (NPWT) standard care

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No