Multi-Center, Prospective, Randomized, Comparison of AWBAT™-D vs. Xeroform™ or Glucan II™ for Treatment of Donor Sites in Burn Surgery



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 70
Updated:4/2/2016
Start Date:August 2009
Contact:Steven Moss
Email:smoss@aubreyinc.com
Phone:760-602-8300

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Trial Summary
Trial Overview
Inclusion Criteria
The purpose of this study is to compare the rate of healing and the non-adherence of three
types of dressings. The study will also compare rate of infection, scarring and perception
of pain associated with treatment.

The purpose of this study is to evaluate AWBAT™-D compared to Xeroform™ or Glucan II™ for
the treatment of donor sites in burn surgery.

Primary Study Goals:

- To compare the rate of healing of donor sites.

- To compare patient reported perception of pain

- To compare the potential clinical complication rates of:

- non-adherence,

- seroma

- hematoma

- infection

Secondary Study Goal:

• To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.

Inclusion Criteria:

- Burn wounds measuring 1% - 30% TBSA requiring skin grafting

- Anterior bilateral donor sites of approximately the same size taken from the thighs
or abdomen

Exclusion Criteria:

- Ventilator dependence

- Pregnancy /Lactation

- Mechanism of injury was electrical, chemical or frostbite

- Co-morbidity which may compromise healing

- Known allergy to porcine or porcine products
We found this trial at
3
sites
Firefighter's Regional Burn Center
Memphis, Tennessee 38103
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Memphis, TN
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The University Hospital Burn Center Cincinnati
Cincinnati, Ohio 45219
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Cincinnati, OH
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Wishard Health Services Burn Center
Indianapolis, Indiana 46204
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Indianapolis, IN
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