A Postmarket Randomized Study of the Treatment of Superficial Partial-Thickness Burns Using Two Dressings

Not Applicable

Terminated

• Conditions: Burns

• Registration Number: NCT01067729
• Lead Sponsor: Aubrey Inc.

Brief Summary

The purpose of this research study is to compare the rate of healing, the infection or complication rate, pain perception and scarring from burn injuries using two types of burn dressings.

Detailed Description

The purpose of this study is to evaluate AWBAT™ compared to Biobrane® for the treatment of superficial partial-thickness burns using the patient as their own control.

Study Timeline

• Study Start: 2009-11
• Status Verified: 2010-02
• Study First Submitted: 2010-02-10
• Study First Submitted QC: 2010-02-11
• Study First Posted: 2010-02-12
• Primary Completion: 2011-06
• Last Update Submitted: 2015-01-23
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Superficial partial thickness burns
• Two non-contiguous burn sites or the same approximate size/depth for comparison, OR
• One burn site large enough to accommodate both a 6" square AWBAT™ dressing and a 6 " square Biobrane® dressing
• Burn wounds measuring >2% - <40% TBSA
• Patient age: >1 - 70 years

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
Rate of healing	Day 14

Secondary Outcome Measures

Name	Time	Method
Scarring	6 months, 1 year, 18 months and 2 years

Trial Locations

Locations (3)

University of Missouri Health Care; 🇺🇸 Columbia, Missouri, United States

UC Irvine Burn Center; 🇺🇸 Irvine, California, United States

Shriners Hospitals for Children; 🇺🇸 Galveston, Texas, United States