Update on tissue-engineered biological dressings

Tissue-engineered biological dressings offer promise in the treatment of burns, chronic ulcers, donor site and other surgical wounds, and a variety of blistering and desquamating dermatologic conditions. For example, the prevalence of diabetic foot ulcers ranges from 4.4% to 10.5% of diabetics, resulting in 82,000 lower extremity amputations annually; venous leg ulcers affect 0.18% to 1.35% of the population; and pressure ulcers are found in 5.0% to 8.8% of institutionalized patients and 14.8% of patients in acute care facilities. Despite the large number of potential beneficiaries, cellular tissue- engineered products have suffered setbacks in recent years and have garnered considerably lower market share than commercial promoters anticipated. The mechanism of action of these products is not universally agreed upon, but delivery of growth factors and extracellular matrix components to the wound is thought to be important; graft "take'' is not usually considered to occur. These "engineered'' products do not specifically match a treatment modality to an underlying pathology. Clinical effect is often modest, and sometimes not justifiable from a cost - benefit perspective. Nevertheless, clinical reports in the literature of uses of tissue-engineered biological dressings continue to mount, indicating that these products are finding niche applications where clinical utility is high and the cost can be defended. Despite commercial setbacks, the first- approved products, Dermagraft((R)), Apligraf((R)), and Cultured Epidermal Autograft (Epicel((R))) are still being marketed, and new ones, such as OrCel((R)), continue to be developed. The major indications for these products are summarized and a brief review of the available clinical literature is offered.