Dermal Coverage of Traumatic War Wounds
Technical Report,31 Oct 2012,30 Oct 2016
The Geneva Foundation Tacoma United States
Pagination or Media Count:
The proposed study is a prospective, randomized within-patient controlled feasibility study to evaluate the safety and effectiveness of the ReCell Device for re-epithelialization 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 morbidity2,3. The performance of ReCell over INTEGRA MBWM in combination with 16 meshed split-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 re-epithelialize 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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- Anatomy and Physiology
- Medical Facilities, Equipment and Supplies