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

NCT00952120 | Completed Phase 3 Results

• 1 other identifier: 16863B
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wound Healing

Keywords

Wound healing; Negative pressure wound therapy; Skin graft

Outcome Measures

Primary Outcomes (1)

• Percentage of Wounds With Complete Skin Graft Take

  For each wound, the percentage of the skin graft that took by Day 4 or 5 was calculated. Complete take is defined as 100% take or skin graft incorporation.

  Day 4 or 5

Secondary Outcomes (1)

• Percentage of Wounds With Total Skin Graft Loss

  Day 4 or 5

Study Arms (2)

GSUC

EXPERIMENTAL

Gauze-based wall suction negative pressure wound therapy for 4-5 days

Device: GSUC

Vacuum-assisted closure

ACTIVE COMPARATOR

Vacuum-assisted closure (VAC) negative pressure wound therapy using commercially available device (KCI, Inc) for 4-5 days

Device: VAC

Interventions

GSUC DEVICE

Gauze-based wall suction negative pressure wound therapy

GSUC

VAC DEVICE

Commercially available Wound VAC negative pressure wound therapy device (KCI, Inc.)

Vacuum-assisted closure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

University of Chicago Medical Center, Section of Plastic and Reconstructive Surgery

Chicago, Illinois, 60637, United States

Location

Results Point of Contact

• Title: Lawrence Gottlieb
• Organization: University of Chicago

lgottlie@surgery.bsd.uchicago.edu

(773) 702-6302

Study Officials

• Lawrence J Gottlieb, MD

  University of Chicago, Section of Plastic and Reconstructive Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2009
• First Posted: August 4, 2009
• Study Start: May 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: July 1, 2012
• Last Updated: September 24, 2015
• Results First Posted: September 24, 2015

Record last verified: 2015-08

Locations

US (1)