Comparison of Two Methods of Securing Skin Grafts Using Negative Pressure Wound Therapy: Vacuum Assisted Closure (VAC) and Gauze Suction (GSUC)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00952120
First received: July 31, 2009
Last updated: September 30, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to compare how well two methods (VAC and G-SUC) of securing skin grafts using negative pressure wound therapy work. Negative pressure wound therapy is a commonly used method of applying suction on wounds to remove fluid from wound and to promote healing. The VAC system is widely used and consists of a foam dressing and a portable computerized suction pump. The G-SUC method uses commonly available dressing supplies attached to vacuum (suction) pump located on the wall above a hospital bed. The investigators have frequently used both methods over the past 10 years and have not observed any specific negative side effects of either.


Condition Intervention Phase
Wound Healing
Device: GSUC
Device: VAC
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-equivalence Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Two Methods of Securing Skin Grafts Using Negative Pressure Wound Therapy: VAC and GSUC

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • Data for Primary Outcomes: (intended to establish that G-SUC is not inferior to VAC) 1. Percentage take in meshed grafts and sheet grafts 2. Skin graft size [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Data for Secondary Outcomes: (intended to establish G-SUC is cheaper, and can be used in wounds where VAC cannot) 1. Failure to maintain dressing because of fluid or suction leaks 2. Time spent on dressing changes 3. Cost of supplies and rental [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 156
Study Start Date: May 2009
Estimated Study Completion Date: October 2014
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSUC
Gauze-based wall suction negative pressure wound therapy
Device: GSUC
Gauze-based wall suction negative pressure wound therapy
Active Comparator: VAC
Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc)
Device: VAC
Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adult patients of any sex, hospitalized at the University of Chicago Medical Center, requiring split thickness skin autografts with wounds that are amenable to placement of an occlusive dressing for negative pressure therapy will be eligible to participate in the study

Exclusion Criteria:

  • Pregnant women, children under 18 years of age and other patients who are "vulnerable" as defined by the Institutional Review Board will not be eligible for the study
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00952120

Locations
United States, Illinois
University of Chicago Medical Center, Section of Plastic and Reconstructive Surgery
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Lawrence J Gottlieb, MD University of Chicago, Section of Plastic and Reconstructive Surgery
  More Information

No publications provided

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00952120     History of Changes
Other Study ID Numbers: 16863B
Study First Received: July 31, 2009
Last Updated: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Wound healing
Negative pressure wound therapy
Skin graft

ClinicalTrials.gov processed this record on October 30, 2014