Awbat Versus Biobrane in Partial Thickness Burns
|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)|
- Time to complete Healing [ Time Frame: 5 - 14 days post injury/membrane application ] [ Designated as safety issue: No ]
- Occurence of Infection [ Time Frame: entire study period ] [ Designated as safety issue: Yes ]
|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)|
One-time application of dressing over partial-thickness burns
Active Comparator: 2
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 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®.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00847496
|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|