Autologous Skin Cell Spray for Massive Soft Tissue War Injuries: A Prospective, Case-Control, Multicenter Trial.

摘要

The goal of this research is to assess the success of skin cell spray combined with a biocomposite subcutaneous (INTEGRA) layer for repair of large open wounds. The objective is the treatment of extremity skin and soft tissue defects with an autologous skin cell spray transplantation in combination with dermal regenerative matrices (Integra). In this case control randomization design, after all patients are treated with dermal matrix, patients will be randomized to Arm 1 (control group; standard skin grafting with 1:1.5 meshing); Arm 2 (experimental group 1; wide 1:6 mesh graft with sprayed cells), and Arm 3 (experimental group 2; sprayed cells only, no graft). To measure the outcome of specific aim 1, all patients will be assessed with serial photography, range of motion testing, functional limb use, and objective measures of gross wound healing (wound size measurements and Image J analysis), as will healing on the cellular level (serial post-graft biopsies). Patients will be followed for 6 months after treatment to define long-term outcomes.