Comparison of Two Methods of Securing Skin Grafts Using Negative Pressure Wound Therapy: Vacuum Assisted Closure (VAC) and Gauze Suction (GSUC)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by University of Chicago.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Chicago
Information provided by:
University of Chicago
ClinicalTrials.gov Identifier:
NCT00952120
First received: July 31, 2009
Last updated: July 6, 2010
Last verified: July 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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: | December 2011 |
| Estimated Primary Completion Date: | December 2010 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952120
Contacts
| Contact: Mieczyslawa Franczyk, PT, PhD | 7737020577 | Mieczyslawa.Franczyk@uchospitals.edu |
| Contact: Justine C Lee, MD, PhD | 7737021000 | justine@uchicago.edu |
Locations
| United States, Illinois | |
| University of Chicago Medical Center, Section of Plastic and Reconstructive Surgery | Recruiting |
| 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: | Lawrence J. Gottlieb, MD Professor of Surgery, University Of Chicago Medical Center |
| ClinicalTrials.gov Identifier: | NCT00952120 History of Changes |
| Other Study ID Numbers: | 16863B |
| Study First Received: | July 31, 2009 |
| Last Updated: | July 6, 2010 |
| 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 May 23, 2013