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

January 11, 2018 updated by: Yale University

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale University, Section of Plastic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Vacuum-assisted closure (VAC) therapy
Following closure of the incision, patients will have incisional vacuum-assisted closure (VAC) therapy performed.
Procedure: 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.
Other Names:
  • Negative-pressure wound therapy (NPWT)
Active Comparator: Gauze dressing
Following closure of the incision, patients will either have a gauze dressing placed over the incision.
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.
Other Names:
  • standard care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post Operative Wound Complications
Time Frame: 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.
Between 2 and 5 days following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Sarah Persing, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2015

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

April 1, 2017

Study Registration Dates

First Submitted

August 13, 2015

First Submitted That Met QC Criteria

August 24, 2015

First Posted (Estimate)

August 27, 2015

Study Record Updates

Last Update Posted (Actual)

January 16, 2018

Last Update Submitted That Met QC Criteria

January 11, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1511016790

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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