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NCT01067729 Clinical Trial

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

Burns Clinical Trial

Official title:
A Multi-Center, Randomized, Prospective Study of the Treatment of Superficial Partial-Thickness Burns: AWBAT™ vs. Biobrane®

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01067729
Other study ID # #AW-101508MC
Secondary ID
Status Terminated
Phase N/A
First received February 10, 2010
Last updated January 23, 2015
Start date November 2009

Study information
Verified date February 2010
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 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 0
Est. completion date
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 70 Years
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Device:
• AWBAT Wound Dressing
TBD
• AWBAT™, Biobrane®
Comparison of burn dressings on randomized body sites using patient as own control

Locations
Country Name City State
United States University of Missouri Health Care Columbia Missouri
United States Shriners Hospitals for Children Galveston Texas
United States UC Irvine Burn Center Irvine California

Sponsors (1)
Lead Sponsor Collaborator
Aubrey Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of healing Day 14 No
Secondary Scarring 6 months, 1 year, 18 months and 2 years No
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