Temporary wound cover from human cells approved

FDA Consumer, July-August, 1997

The first wound covering made with human cells has been approved by FDA to temporarily cover severe burn wounds until a patient's own skin can be transplanted.

Each year, about 51,000 Americans are hospitalized for serious burns, and 5,500 die. Covering wounds quickly with temporary skin substitutes can help prevent infection and minimize scarring and trauma.

The new Dermagraft-TC wound covering is grown in a laboratory from human cells, then frozen and packaged. To use, the surgeon unfreezes the temporary skin, then stretches it over the burn site. The surgeon removes the temporary covering when the patient's own skin is ready to be grafted, usually in 7 to 14 days.

Dermagraft-TC has not been tested in pregnant women or children under age 2, or on burns from electrical or chemical causes or on the head, hands, feet, or buttocks.

FDA's March 19 approval followed a recommendation from the General and Plastic Surgery Panel of the agency's Medical Devices Advisory Committee.

A study of 89 burn patients treated with Dermagraft-TC showed that it covered burns as effectively as frozen cadaver skin from tissue banks.

FDA's safety review focused on the risk of disease transmission because of the product's use of human cells. The cells met FDA guidelines for cell testing. The cells were tested for known disease-producing elements, such as bacteria, fungi and viruses. The final product was tested for bacteria and fungi.

Some data raised the possibility of a higher risk of infection from the Dermagraft-TC. At FDA's request, the manufacturer, Advanced Tissue Sciences of La Jolla, Calif., will conduct a postmarket study of 200 patients to evaluate this risk.

(For more information on skin substitutes, see "Second Skins" in the January-February 1997 FDA Consumer.)