The Treatment of Partial-Thickness Burns: AWBAT Versus Biobrane

This study is not yet open for participant recruitment.

Verified by University of Missouri-Columbia, November 2008

Sponsors and Collaborators:	University of Missouri-Columbia Aubrey Inc.
Information provided by:	University of Missouri-Columbia
ClinicalTrials.gov Identifier:	NCT00793533

Purpose

The purpose of this study is to determine if AWBAT, used in treating partial-thickness burns, would provide better healing, pain control, control of infection, shorter length of hospital stay, lower costs, and improved scarring and long term recovery when compared to Biobrane.

Condition	Intervention
Burns	Procedure: Biobrane vs AWBAT skin substitute

MedlinePlus related topics: Burns

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	The Treatment of Partial-Thickness Burns: AWBAT Versus Biobrane

Further study details as provided by University of Missouri-Columbia:

Primary Outcome Measures:

daily monitoring of wounds, wound healing and pain, visible signs of infection [ Time Frame: daily ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

wound healing and scar assessment [ Time Frame: daily ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

compare AWBAT to Biobrane for covering partial thickness burn injuries

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

18 and older
2nd degree burn >2 % and <40%

Exclusion Criteria:

Allergy to porcine materials

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	University of Missouri Healthcare ( Dr. James J. Kraatz, MD )
Study ID Numbers:	UMC PPF 0-17
Study First Received:	November 17, 2008
Last Updated:	November 18, 2008
ClinicalTrials.gov Identifier:	NCT00793533
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:

burns
partial thickness
wound dressings

Biobrane
AWBAT
Partial Thickness Burns

Study placed in the following topic categories:

Burns
Wounds and Injuries
Disorders of Environmental Origin

ClinicalTrials.gov processed this record on January 15, 2009