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Awbat Versus Biobrane in Partial Thickness Burns

This study has been withdrawn prior to enrollment.
(Company went out of business)
Sponsor:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT00847496
First received: February 17, 2009
Last updated: July 19, 2012
Last verified: July 2012
History of Changes
  Purpose

• 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 Phase
Burns
 Device: AWBAT
Device: Biobrane
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Treatment of Partial Thickness Burns: Awbat(r) Versus Biobrane(r)

Resource links provided by NLM:

MedlinePlus related topics: Burns
U.S. FDA Resources

Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Time to complete Healing [ Time Frame: 5 - 14 days post injury/membrane application ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurence of Infection [ Time Frame: entire study period ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: December 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
AWBAT
 Device: AWBAT
One-time application of dressing over partial-thickness burns
Active Comparator: 2
BIOBRANE(R)
 Device: Biobrane
One-time application over partial-thickness burns

Detailed Description:

Currently there is no "best covering" or a standard "approved care" for treating partial thickness burns. Several options are available; however, they all have shortcomings. The application of topical antimicrobial dressings is time consuming and the regular dressing changes often associated with pain. Homograft or cadaver skin is often unavailable or in great shortage for skin transplants. Biobrane®, a biosynthetic wound dressing constructed of a silicone film with a nylon fabric partially imbedded into the film, has been available and used at our institute for many years as a skin substitute. It has been shown to reduce pain and the number of necessary dressing changes, and significantly reduced healing time (1). Its main side effects, although rare, are the occasional occurrence of infections and allergic reactions to the material.

Recently, a new product, AWBAT, has been developed for the coverage of partial thickness burns. AWBAT is similar to Biobrane® in terms of silicone membrane thickness, the structure of nylon fabric that gives the dermal substitute its strength, and the use of collagen peptides on the inner side of the membrane. These peptides are used for the purpose of reacting with the fibrin in the wound in order to achieve good initial adherence and to accelerate re-epithelialization. The key novelties of AWBAT are the different pore size and modality of collagen peptide attachments. These two key modifications aim at a reduction of the above mentioned adverse reactions.

The purpose of this study is to compare AWBAT to Biobrane® for covering partial thickness-burn injuries. We wish to determine if AWBAT, used in treating partial-thickness burns, would provide better healing, pain control, control of infection, shorter length of hospital stay, and improved scarring and long term recovery when compared to Biobrane®.

  Eligibility

Ages Eligible for Study:   3 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Partial thickness burns between 4% and 40% Total Body Surface Area(TBSA)
  • Full thickness burns not to exceed 10% TBSA,
  • Age as specified

Exclusion Criteria:

  • Full thickness burns that require immediate excision and grafting
  • Known allergic reaction against Biobrane
  • Chemical and electrical burns
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847496

Locations
United States, Texas
Shriners Hospital for Children
Galveston, Texas, United States, 77550
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: David N Herndon, MD Shriners Hospital for Children and University of Texas Medical Branch
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT00847496     History of Changes
Obsolete Identifiers: NCT00793533
Other Study ID Numbers: 08-333
Study First Received: February 17, 2009
Last Updated: July 19, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by The University of Texas, Galveston:
Partial Thickness burn
Biological Dressing

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on September 26, 2012