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

Sponsor

Aubrey Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT01067729

Collaborator

(none)

Locations

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Burns	Device: AWBAT Wound Dressing Device: AWBAT™, Biobrane®	N/A

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 Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Jun 1, 2011

Outcome Measures

Primary Outcome Measures

Rate of healing [Day 14]

Secondary Outcome Measures

Scarring [6 months, 1 year, 18 months and 2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UC Irvine Burn Center	Irvine	California	United States	92868
2	University of Missouri Health Care	Columbia	Missouri	United States	65212
3	Shriners Hospitals for Children	Galveston	Texas	United States	77550