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Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

This study has been terminated.
(PI decided to use another product)
Sponsor:
Information provided by:
United States Army Institute of Surgical Research
ClinicalTrials.gov Identifier:
NCT00352729
First received: July 13, 2006
Last updated: January 8, 2008
Last verified: December 2007
History of Changes

July 13, 2006
January 8, 2008
November 2006
August 2007   (final data collection date for primary outcome measure)
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 ]
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.
Complete list of historical versions of study NCT00352729 on ClinicalTrials.gov Archive Site
 
 
 
 
 
Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites
Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

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.

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.
Interventional
 
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Burns
Device: ACell dressing
dressing
Active Comparator: A
Intervention: Device: ACell dressing
Badylak SF. Xenogeneic extracellular matrix as a scaffold for tissue reconstruction. Transpl Immunol. 2004 Apr;12(3-4):367-77. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00352729
H-06-002
No
Leopoldo Cancio, LTC, MC, USAISR
United States Army Institute of Surgical Research
 
Principal Investigator: Michael Albrecht, MD U.S. Army Institute of Surgical Research
United States Army Institute of Surgical Research
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP