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| Sponsored by: |
The University of Texas, Galveston |
|---|---|
| Information provided by: | The University of Texas, Galveston |
| ClinicalTrials.gov Identifier: | NCT00847496 |
Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
Burns |
Device: AWBAT Device: Biobrane |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | The Treatment of Partial Thickness Burns: Awbat(r) Versus Biobrane(r) |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2009 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
AWBAT
|
Device: AWBAT
One-time application of dressing over partial-thickness burns
|
|
2: Active Comparator
BIOBRANE(R)
|
Device: Biobrane
One-time application over partial-thickness burns
|
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 necessesary 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 |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Marc G Jeschke, MD, PhD | 409-770-6742 | majeschk@utmb.edu |
| United States, Texas | |
| Shriners Hospital for Children | |
| Galveston, Texas, United States, 77550 | |
| Principal Investigator: | David N Herndon, MD | Shriners Hospital for Children and University of Texas Medical Branch |
More Information
| Responsible Party: | Shriners Hospital for Children ( David N. Herndon, MD/Professor of Surgery ) |
| Study ID Numbers: | 08-333 |
| Study First Received: | February 17, 2009 |
| Last Updated: | February 18, 2009 |
| ClinicalTrials.gov Identifier: | NCT00847496 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Partial Thickness burn Biological Dressing |
|
Burns Wounds and Injuries Disorders of Environmental Origin |
|
Burns Wounds and Injuries Disorders of Environmental Origin |
