Manual Implantation of Full-Thickness Skin Microcolumns

Previously three patients have been successfully treated with the use of manual FTSM for wound coverage. To provide additional proof of concept data, this study will validate manual FTSM implantation on a larger scale with a 10-patient population. This will be measured by the following hypothesized parameters: time to re-epithelization, pigmentation, wound contraction, scar thickness, pain at the donor site and injury site healing outcome. The approach to testing this hypothesis will be to perform manual FTSM harvest, placement on the injured site, covered by an inert dressing for 10 patients with open wounds necessitating tissue coverage. The rationale is that although preliminary proof of concept data has already been obtained from three patients treated with FTSM implantation, additional proof of concept data would strengthen the conclusions made based on these cases.

Inclusion criteria

• 8-85 years of age
• 10-125 cm2 open wound on the scalp, neck, torso or extremities necessitating tissue coverage
• Sufficiently healthy skin to serve as a donor site

Exclusion criteria

• Wound area involving the face*
• Wound area involving joints*
• Pregnancy
• Prisoner
• Active wound infection at potential treatment sites
• Exposed muscle, joint, tendon, or bone within the wound bed