Burns Clinical Trial
Official title:
The Treatment of Partial Thickness Burns: Awbat(r) Versus Biobrane(r)
• 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®.
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®.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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