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Dermal Coverage of Traumatic War Wounds

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Technical Report,31 Oct 2014,30 Oct 2015

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The Geneva Foundation Tacoma United States

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The proposed study is a prospective, randomized within-patient controlled feasibility study to evaluate the safety and effectiveness of the ReCell Device for reepithelialization of full thickness wounds treated with INTEGRA MBWM. The ReCell Device is a stand-alone, battery operated cell separation device that enables preparation of a cell suspension from a small, thin, split-thickness skin biopsy. The autologous epidermal cell suspension is available for immediate delivery onto a prepared skin surface. This process has the potential to enhance skin regeneration while minimizing donor site morbidity. The performance of ReCell over INTEGRA MBWM in combination with 16 meshedsplit-thickness skin graft STSG will be compared to standard practice control i.e.,11.5 meshed STSG over Integra MBWM. We expect all ReCell-treated and control areas of the wounds to heal adequately. However, we predict areas treated with ReCell will reepithelialize more quickly than control areas, which has the potential to reduce the risk of infection and scarring in ReCell-treated areas compared to control areas.

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