Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

Not Applicable

Withdrawn

• Conditions: Burns
• Interventions: Device: ACell dressing

• Registration Number: NCT00352729
• Lead Sponsor: United States Army Institute of Surgical Research

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.

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.

Study Timeline

• Study First Submitted: 2006-07-13
• Study First Submitted QC: 2006-07-13
• Study First Posted: 2006-07-17
• Study Start: 2006-11
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-20
• Last Update Posted: 2015-07-21

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	ACell dressing	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

U.S. Army Insitute of Surgical Research; 🇺🇸 Fort Sam Houston, Texas, United States