Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites
| Status: | Withdrawn |
|---|---|
| Conditions: | Other Indications |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | November 2006 |
| End Date: | August 2007 |
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.
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.
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.
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
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