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

Not Applicable

• Conditions: Treatment of Donor Site Burns

• Registration Number: NCT00964470
• Lead Sponsor: Aubrey Inc.

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2009-08
• Study First Submitted: 2009-08-23
• Study First Submitted QC: 2009-08-24
• Study First Posted: 2009-08-25
• Status Verified: 2009-09
• Last Update Submitted: 2010-06-21
• Last Update Posted: 2010-06-22
• Primary Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
• To compare the rate of healing of donor sites. • To compare patient reported perception of pain • To compare the potential clinical complication rates of: o non-adherence, o seroma o hematoma o infection	2 year follow-up

Secondary Outcome Measures

Name	Time	Method
• To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.	2 year follow-up

Trial Locations

Locations (3)

Wishard Health Services Burn Center; 🇺🇸 Indianapolis, Indiana, United States

The University Hospital Burn Center Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Firefighter's Regional Burn Center; 🇺🇸 Memphis, Tennessee, United States