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

Treatment of Donor Site Burns Clinical Trial

— AWBAT-D  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00964470
• Other study ID #: #AW-101008MC-DS
• Status: Recruiting
• Phase: N/A
• First received: August 23, 2009
• Last updated: June 21, 2010
• Start date: August 2009

Study information

• Verified date: September 2009
• Source: Aubrey Inc.
• Contact: Steven Moss
• Phone: 760-602-8300
• Email: smoss[@]aubreyinc.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Treatment of Donor Site Burns

Intervention

Device:
• AWBAT™-D and XEROFORM™ OR GLUCAN II™ dressings
Dressing, donor site dressings

Locations

Country	Name	City	State
United States	The University Hospital Burn Center Cincinnati	Cincinnati	Ohio
United States	Wishard Health Services Burn Center	Indianapolis	Indiana
United States	Firefighter's Regional Burn Center	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Aubrey Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	• 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	No
Secondary	• To compare clinical outcome of donor sites: scarring based on the Vancouver Scar Scale.		2 year follow-up	No