FDA
TALK PAPER

Food and Drug Administration
U.S. Department of Health and Human Services
Public Health Service 5600 Fishers Lane Rockville, MD 20857
FDA Talk Papers are prepared by the Press Office to guide FDA personnel in responding with consistency and accuracy to questions from the public on subjects of current interest. Talk Papers are subject to change as more information becomes available. 


T97-14                        Sharon Snider 
March 19, 1997                
                                   
      
    FDA APPROVES TEMPORARY SKIN SUBSTITUTE FOR BURN PATIENTS
     The Food and Drug Administration has approved a temporary
skin substitute for people who are severely burned and in need of
wound covering until their skin can be grafted.
      The product is Dermagraft-TC developed by Advanced Tissue
Sciences of La Jolla, Calif., and produced from human cells grown
in a laboratory.  
     A serious burn is one of the most horrendous traumas the
body can suffer.  Every year, an estimated  51,000 Americans are
hospitalized for burn treatment, and 5,500 die.
     The need to cover wounds as quickly as possible to help
prevent infection and minimize scarring and additional trauma has
driven development of advanced wound dressings and temporary skin
substitutes.  Dermagraft-TC is different from other temporary
skin substitutes in that it uses human cells.
     The new product consists of a polymer membrane and human
cells which are incubated and grown in a laboratory on a nylon
mesh under aseptic conditions.  The product is then frozen and
packaged in 5x7 l/2 inch pieces.  Freezing kills the cells but
leaves the tissue matrix and cell growth factors intact.
     To use, the surgeon unfreezes the product and stretches it
over the burn site. When the patient's own skin is ready to be
grafted, usually in 7 to 14 days, the device is removed.
     FDA's approval of the device was based on a review of
clinical studies on safety and effectiveness conducted by the
manufacturer and on the recommendation of the General and Plastic
Surgery Panel of FDA's Medical Devices Advisory Committee.
     The firm studied 89 burn patients treated with the product
at 12 sites in the U.S.  The studies found that 
Dermagraft-TC was as effective as frozen allograft (cadaver skin
from tissue banks) in covering burns.
      Data from part of the study raised the possibility of a
somewhat higher risk of infection from use of the product
compared to use of allograft.  FDA has asked the manufacturer to
conduct a post-market study of 100 patients to evaluate this
risk.
     Because the product uses human cells, FDA's safety review
focused closely on the risk of disease transmission.  The cells
used in the product met all FDA guidelines for cell testing. 
These include testing for known human pathogens, such as
bacteria, fungi, viruses and microplasma.  In addition to being
prepared in a controlled aseptic environment, the product
underwent final testing for the presence of bacteria, fungi and
microplasma. 
     The safety and effectiveness of Dermagraft-TC has not been
established in pregnant women, children under age two, or on
burns on the head, hands, feet or buttocks or on burns caused by
electrical or chemical sources.
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