A Phase 2 interventional study of AWBAT and Biobrane in Burns, sponsored by The University of Texas Medical Branch, Galveston. Withdrawn at 1 site in United States. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2012-12-11.
Sponsored by The University of Texas Medical Branch, Galveston · Phase 2, Interventional, and Treatment
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®.
719 studies on the registry are indexed under Burns; 145 are open to participants now.
Browse Burns studies →The University of Texas Medical Branch, Galveston is the lead sponsor of 251 studies on the registry; 38 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 25 (83%) have results posted.
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Exclusion Criteria:
AWBAT
Device: AWBAT
BIOBRANE(R)
Device: Biobrane
One-time application of dressing over partial-thickness burns
One-time application over partial-thickness burns
Time to complete Healing
Time frame: 5 - 14 days post injury/membrane application
Occurence of Infection
Time frame: entire study period
This study is withdrawn, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
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The University of Texas Medical Branch, Galveston