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

This study has been terminated.
Information provided by:
Aubrey Inc. Identifier:
First received: February 10, 2010
Last updated: January 23, 2015
Last verified: February 2010
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 Intervention
Burns Device: AWBAT Wound Dressing Device: AWBAT™, Biobrane®

Study Type: Interventional
Study Design: 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®

Resource links provided by NLM:

Further study details as provided by Aubrey Inc.:

Primary Outcome Measures:
  • Rate of healing [ Time Frame: Day 14 ]

Secondary Outcome Measures:
  • Scarring [ Time Frame: 6 months, 1 year, 18 months and 2 years ]

Study Start Date: November 2009
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: AWBAT Wound Dressing
    Other Name: Biobrane
    Device: AWBAT™, Biobrane®
    Comparison of burn dressings on randomized body sites using patient as own control
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.

Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01067729

United States, California
UC Irvine Burn Center
Irvine, California, United States, 92868
United States, Missouri
University of Missouri Health Care
Columbia, Missouri, United States, 65212
United States, Texas
Shriners Hospitals for Children
Galveston, Texas, United States, 77550
Sponsors and Collaborators
Aubrey Inc.
  More Information

Responsible Party: Stephen Moss/President, Aubrey Inc. Identifier: NCT01067729     History of Changes
Other Study ID Numbers: #AW-101508MC
Study First Received: February 10, 2010
Last Updated: January 23, 2015

Keywords provided by Aubrey Inc.:
Superficial burns
Partial thickness burns
Rate of healing
Infection rate
Pain perception
Non adherence

Additional relevant MeSH terms:
Wounds and Injuries processed this record on August 18, 2017