Study Stopped
PI decided to use another product
Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites
ACell
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2006
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 13, 2006
CompletedFirst Posted
Study publicly available on registry
July 17, 2006
CompletedStudy Start
First participant enrolled
November 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedJuly 21, 2015
July 1, 2015
9 months
July 13, 2006
July 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
14 days
Study Arms (1)
A
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
U.S. Army Insitute of Surgical Research
Fort Sam Houston, Texas, 78234, United States
Related Publications (1)
Badylak SF. Xenogeneic extracellular matrix as a scaffold for tissue reconstruction. Transpl Immunol. 2004 Apr;12(3-4):367-77. doi: 10.1016/j.trim.2003.12.016.
PMID: 15157928BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Albrecht, MD
U.S. Army Institute of Surgical Research
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
Study Record Dates
First Submitted
July 13, 2006
First Posted
July 17, 2006
Study Start
November 1, 2006
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
July 21, 2015
Record last verified: 2015-07