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

Aubrey Inc.

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Burns

Interventions

AWBAT Wound DressingDEVICE

AWBAT™, Biobrane®DEVICE

Comparison of burn dressings on randomized body sites using patient as own control

Eligibility

Sex: ALLMin age: 1 YearMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (3)

UC Irvine Burn Center

Irvine, California, United States

University of Missouri Health Care

Columbia, Missouri, United States

Shriners Hospitals for Children

Galveston, Texas, United States

Outcomes

Primary Outcomes

Rate of healing

Time frame: Day 14

Secondary Outcomes

Scarring

Time frame: 6 months, 1 year, 18 months and 2 years

Data from ClinicalTrials.gov

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