Hypertrophic Scarring After Burn Injury Clinical Trial
Official title:
Effectiveness of Pressure Garment Therapy After Burns
Purpose - To determine the effectiveness of custom-fit pressure garment therapy in the
prevention of hypertrophic scarring in healed burns.
Background - Approximately one million people are burned each year in the United States. The
most devastating outcomes following burns is the ugly, itchy, hypertrophic scar that
interferes with work and all other aspects of life. Pressure garment therapy is routinely
used to minimize hypertrophic scarring even though there is no scientifically valid data
that this therapy is efficacious. Pressure garments are extremely unattractive, expensive
and uncomfortable and their use needs to be based upon valid data.
Goals and Objectives - The investigators plan to determine the effectiveness of pressure
garment therapy in the control of hypertrophic scarring in healed burns.
Methods - The I-Scan® device was designed to measure pressure at the body/environment
interface and allows clinicians to deal with pressure-related problems for at-risk patients.
It has been widely used in rehabilitation medicine but not with burn survivors. The
investigators will use this device to measure the pressure at the garment/skin interface. 2)
Furthermore, the few studies that have been attempted to determine efficacy have used
between subjects designs. Since burn depth is extremely variable from patient to patient and
since hypertrophic scarring is greatly influenced by age and race/origin, the between
subjects design requires very large numbers of subjects. The investigators will use a within
wounds design studying forearm burns and applying pressure to half of the wound and no
pressure to the other half. The investigators will then compare hardness, color, thickness
and clinical appearance.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment