Accession Number:

ADA621334

Title:

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

Descriptive Note:

Final rept. 15 Mar 2013-31 Oct 2014

Corporate Author:

GENEVA FOUNDATION TACOMA WA

Personal Author(s):

• Fleming, Mark E.

Report Date:

2015-01-01

Pagination or Media Count:

11.0

Abstract:

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 11.5 meshing Arm 2 experimental group 1 wide 16 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.

Descriptors:

• *CELLS(BIOLOGY)
• *REGENERATIVE MEDICINE
• *SKIN(ANATOMY)
• *SOFT TISSUES
• *WOUNDS AND INJURIES
• CLINICAL TRIALS
• EXTREMITIES
• HEALING
• SKIN GRAFTS
• SPRAYS
• TRAUMA

Subject Categories:

• Biology
• Anatomy and Physiology
• Medicine and Medical Research

Distribution Statement:

APPROVED FOR PUBLIC RELEASE