CLINICAL TRIAL
COMPARATIVE STUDY
JOURNAL ARTICLE
MULTICENTER STUDY
RANDOMIZED CONTROLLED TRIAL
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Tissue engineering in wound repair.

Tissue-engineering products can cover wounds and provide a microenvironment that stimulates their repair. To date, Graftskin (APLIGRAF, Organogenesis Inc, Canton, MA, and Novartis Pharmaceuticals Corporation, East Hanover, NJ) is the most advanced bioengineered skin product. Graftskin is a bilayered living skin construct consisting of a dermis and a well-differentiated epidermis. The epidermal cells (keratinocytes) and dermal cells (fibroblasts) are obtained from neonatal foreskin. The efficacy of Graftskin in healing venous ulcers was evaluated in a prospective, randomized study of 240 patients at 14 centers over a 6-month period. Patients received either compression therapy plus Graftskin or compression therapy alone (active control). Clinical efficacy was defined as complete wound closure. Treatment with Graftskin was more effective than compression alone as measured by time to complete wound closure and frequency of complete wound closure by 6 months. When applied to hard-to-heal wounds (> 1 year's duration), Graftskin was 3 times more effective than compression therapy alone in achieving complete wound closure at 8 weeks (32% vs 10%, P = .008) and 2 times more effective by 24 weeks (47% vs 19%, P = .002). Graftskin is highly effective in healing venous ulcers, particularly those of long duration, that have proved hard to heal with conventional modalities.

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