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

Aubrey

Status: Terminated

Conditions: Burns

Treatments: Device: AWBAT Wound Dressing; Device: AWBAT™, Biobrane®

Study type: Interventional

Funder types: Industry

Identifiers

NCT01067729

#AW-101508MC

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)