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

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ClinicalTrials.gov Identifier: NCT01067729
Recruitment Status : Terminated
First Posted : February 12, 2010
Last Update Posted : January 26, 2015
Sponsor:
Information provided by:
Aubrey Inc.

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® Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : November 2009
Actual Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns


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


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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01067729


Locations
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.

Responsible Party: Stephen Moss/President, Aubrey Inc.
ClinicalTrials.gov Identifier: NCT01067729     History of Changes
Other Study ID Numbers: #AW-101508MC
First Posted: February 12, 2010    Key Record Dates
Last Update Posted: January 26, 2015
Last Verified: February 2010

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

Additional relevant MeSH terms:
Burns
Wounds and Injuries