Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery

Burn Surgery Clinical Trial

Official title:

A Randomized, Prospective Comparison of AWBAT™-D and MEPILEX® AG for Treatment of Donor Sites in Burn Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00974597
• Other study ID #: #AW-101008DS
• Status: Terminated
• Phase: N/A
• First received: September 8, 2009
• Last updated: June 21, 2010
• Start date: September 2009

Study information

• Verified date: December 2009
• Source: Aubrey Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine AWBAT™-D compared to Mepilex® Ag for the treatment of donor sites in burn surgery.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 30
• Est. primary completion date: September 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Burn wounds requiring skin grafting

• Matched donor sites available

• 1-30% TBSA

Exclusion Criteria:

• Severe inhalation injury

• Pregnancy

• Co-morbidity which may compromise healing

• Known allergy to pork or pork products

Study Design

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

Related Conditions & MeSH terms

• Burn Surgery
• Burns

Intervention

Device:
• AWBAT™-D and Mepilex® Ag dressings
Comparison of AWBAT™-D and Mepilex® Ag dressings for treatment of donor sites in burn surgery.

Locations

Country	Name	City	State
United States	Doctors Hospital of Augusta	Augusta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Aubrey Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare rate of healing of donor sites		6 month follow-up	No
Secondary	Compare complication rates		6 month follow-up	No
Secondary	Compare patient reported perception of pain		6 month follow-up	No
Secondary	Compare clinical outcome (scarring)		6 month follow-up	No