Wound Healing Clinical Trial
Official title:
Comparison of Two Methods of Securing Skin Grafts Using Negative Pressure Wound Therapy: VAC and GSUC
Verified date | August 2015 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 104 |
Est. completion date | July 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago Medical Center, Section of Plastic and Reconstructive Surgery | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Yes |
Secondary | Percentage of Wounds With Total Skin Graft Loss | For each wound, whether there was total skin graft loss by Day 4 or 5 was determined. | Day 4 or 5 | No |
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