The Metis Foundation
The objective of this study is to validate the proof of concept regarding the approach of manual implantation of full-thickness skin microcolumns (FTSMs) as coverage for open wounds without creating an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.
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…
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
Surgical harvest and implantation of FTSM on an open wound requiring coverage.
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