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Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

Information source: United States Army Institute of Surgical Research
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Burns

Intervention: ACell dressing (Device)

Phase: N/A

Status: Withdrawn

Sponsored by: United States Army Institute of Surgical Research

Official(s) and/or principal investigator(s):
Michael Albrecht, MD, Principal Investigator, Affiliation: U.S. Army Institute of Surgical Research


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.

Clinical Details

Official title: Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: 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.

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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 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

Locations and Contacts

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

Related publications:

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

Starting date: November 2006
Last updated: July 20, 2015

Page last updated: August 20, 2015

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