Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

Burns Clinical Trial

— ACell  

Official title:

Evaluation of ACell Hydrated Wound Dressing for Autogenous Skin Donor Sites

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00352729
• Other study ID #: H-06-002
• Status: Withdrawn
• Phase: N/A
• First received: July 13, 2006
• Last updated: July 20, 2015
• Start date: November 2006
• Est. completion date: August 2007

Study information

• Verified date: July 2015
• Source: United States Army Institute of Surgical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Burns

Intervention

Device:
• ACell dressing
dressing

Locations

Country	Name	City	State
United States	U.S. Army Insitute of Surgical Research	Fort Sam Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
United States Army Institute of Surgical Research

Country where clinical trial is conducted

United States, 

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No