Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites - Full Text View

Sponsored by:	United States Army Institute of Surgical Research
Information provided by:	United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:	NCT00352729

Purpose

The purpose of this study is to see if treating a donor site wound with the ACell dressing is as good as or better than the dressings we currently treat harvested donor sites with. This will be tested on consenting burn patients who require excision and grafting surgery for their burn wounds.

Hypothesis: The mean healing time for wounds treated with the ACell dressing will be less than the mean healing time for wounds treated with the Standard of Care dressing.

Condition	Intervention
Burns	Device: ACell dressing

MedlinePlus related topics: Burns

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

Further study details as provided by United States Army Institute of Surgical Research:

Primary Outcome Measures:

The specific aim of this study is to determine if the ACell dressing is superior to the ISR Burn Center's current standard of care dressing with respect to speed of healing, patient comfort or wound cosmesis. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment:	0
Study Start Date:	November 2006
Study Completion Date:	August 2007
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator	Device: ACell dressing dressing

Detailed Description:

This is a single-center, prospective, randomized, and controlled study to evaluate the effectiveness of the ACell Dressing for use as a dressing for autogenous skin donor sites compared to our current standard donor site dressing, which is currently Xeroform.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

less than 30% total body surface area burn
burn wounds do not involve the donor site harvesting areas
requires excision and grafting of sufficient extent to justify two donor site of roughly equal size on non-dependent body surfaces.
The scheduled excision and grafting procedure is the first such operation for the subject
subject agrees to participate in follow-up evaluations

Exclusion Criteria:

Critical illnesses such as those requiring ventilator support, systemic infection, or hemodynamic instability
Major acute or chronic medical illness that could affect wound healing
Cellulitis or other infection of the potential donor sites
Donor site has been previously harvested for grafting
Subjects who are pregnant
Religious objections or allergy to porcine products

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00352729

Locations

United States, Texas
U.S. Army Insitute of Surgical Research
Fort Sam Houston, Texas, United States, 78234

Sponsors and Collaborators

United States Army Institute of Surgical Research

Investigators

Principal Investigator:

Michael Albrecht, MD

U.S. Army Institute of Surgical Research

More Information

Publications:

Badylak SF. Xenogeneic extracellular matrix as a scaffold for tissue reconstruction. Transpl Immunol. 2004 Apr;12(3-4):367-77. Review.

Responsible Party:	USAISR ( Leopoldo Cancio, LTC, MC )
Study ID Numbers:	H-06-002
Study First Received:	July 13, 2006
Last Updated:	January 8, 2008
ClinicalTrials.gov Identifier:	NCT00352729
Health Authority:	United States: Federal Government

Keywords provided by United States Army Institute of Surgical Research:

Burns
ACell
Donor Site

Study placed in the following topic categories:

Burns

ClinicalTrials.gov processed this record on January 14, 2009