Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

United States Army Institute of Surgical Research

Status

Withdrawn

Conditions

Burns

Treatments

Device: ACell dressing

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00352729

H-06-002

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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