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    Skin substitutes surge ahead

    Wound treatment products prove superior to old guard healing agents, particularly for treatment-resistant chronic maladies open for period of one or more years


    Dr. Falabella
    New Orleans - It is time for dermatologists to incorporate a new generation of active wound treatment products, Anna Falabella M.D., said at the annual meeting of the American Academy of Dermatology.

    "Some skin substitutes have been proven superior, especially for treatment-resistant chronic wounds," reported Dr. Falabella, a wound specialist and assistant professor of dermatology and cutaneous surgery at the University of Miami. "Wounds that have remained open for one, two, three or more years can heal within a few months. They may seem expensive - up to $1,000 apiece - but they are actually cost effective because wounds heal faster."

    Products aimed at specific marketsAs on- and off-label use increases, she predicted a profusion of products to fill niche markets. "The skin substitutes we now have are very thin, and the dermatologist sometimes has to wait until the wound fills in before using them. Future products will have more and more layers and thicknesses and offer more specialized types of cells. Current substitutes utilize extracellular matrix, fibroblasts and keratinocytes, but are lacking endothelial cells, melanocytes, and adnexa."


    Orcel, a bilayered skin substitute, being used for treatment of chronic venous ulcer. (Photograph courtesy of Anna Falabella, M.D.)
    Skin replacements fall into three general categories: epidermal, dermal, and composites. They can be further classified as temporary or permanent; synthetic, biosynthetic, or biologic; autogeneic, allogeneic, or xenogeneic; and matrix only or matrix with cells.

    New developmentsIn March 2001, OrCel joined Apligraf, Dermagraft, and others on the FDA approval list for engineered skins. Produced by Ortec International Inc., Orcel "is a bilayered skin substitute that contains living cells and is cryo-preserved for longer shelf live," the dermatologist said.

    "FDA approved it for use with recessive dystrophic epidermolysis bullosa patients that had mitten-hand deformity; for surgical correction of the deformity and for treatment of the donor site wound."

    In September the product was also was approved for healing donor site wounds in burn victims. The company is now conducting clinical trials in the treatment of venous ulcers.

    Another new product is EpiDex, cultured from autologous outer root sheath cells, by Switzerland-based Modex Therapeutics Ltd. Noted Dr. Falabella, "The dermatologist takes a plug of the patient's hair, sends it to the company, and they make an autograft, so there's no need for the creation of a donor site. Clinical trials are underway in Europe and hopefully we'll be starting trials soon in the United States."

    Low cost, multiple benefitsAmong the porcine products, she highlighted Oasis. Produced by Cook Biotech Inc., it is a naturally occurring extracellular matrix comprised of porcine small intestinal submucosa. At under $100 per sheet, it is used to manage partial and full-thickness skin wounds.

    Another biosynthetic acellular skin substitute is E-Z Derm. E-Z Derm (Brennen Medical Inc.) is a porcine-derived xenograft in which the collagen has been chemically crosslinked with an aldehyde to provide strength, durability, and convenient storage at room temperature. Among others, their advantages include immediate availability and a longer shelf life.

    Dr. Falabella has received research grants from more than a dozen pharmaceutical and biotechnology companies, including Novartis Pharmaceuticals Corp., Advanced Tissue Sciences Inc., and Ortec International Inc.

    Rebecca Bryant
    Rebecca Bryant is a medical writer based in Fayetteville, Arkansas

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