Accession Number:

AD1047259

Title:

Dermal Coverage of Traumatic War Wounds

Descriptive Note:

Technical Report,31 Oct 2012,30 Oct 2016

Corporate Author:

The Geneva Foundation Tacoma United States

Personal Author(s):

Report Date:

2017-01-01

Pagination or Media Count:

11.0

Abstract:

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.

Subject Categories:

  • Medicine and Medical Research
  • Anatomy and Physiology
  • Medical Facilities, Equipment and Supplies

Distribution Statement:

APPROVED FOR PUBLIC RELEASE