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FDA APPROVES RECONSTRUCTIVE SURGERY PRODUCT
FOR PATIENTS WITH SEVERE SCARRING

FDA today expanded the approved use of a product currently marketed to repair skin in people with severe burns.

The product, Integra Dermal Regeneration Template, made by Integra LifeSciences Corp., Plainsboro, N.J., may now be used not only to help treat severe burns, but also to treat the often disabling scars that result. These scars have limited elasticity and, thus, have the effect of immobilizing or "freezing" the skin, preventing limbs from moving or the body part from further developing.

Integra is a two-layer membrane--a dermal layer that is a porous lattice of cross-linked collagen fibers, and a synthetic epidermal layer. The dermal layer acts as a biodegradable template that helps organize dermal tissue regeneration.

To use on scarred tissue, doctors remove the tissue and place Integra over the wound. Integra allows the blood vessels and other cells to re-grow a new layer of skin while the dermal layer is absorbed into the body. The upper synthetic layer helps close the wound and prevent fluid loss. After two to three weeks, the top layer of Integra is removed and a very thin graft of the patient's skin is applied to the wound area.

FDA based its approval of the new use on a clinical study of safety and effectiveness conducted by a burn hospital in England.

The hospital treated 30 scarred areas in 20 patients. All of the scars resulted from severe burns. The study showed that Integra was safe and was able to repair skin over the scarred areas.
Approximately 75,000 people in the U.S. are hospitalized each year for burn injuries, many resulting in severe scarring. Integra may benefit many of the patients.

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