An interventional study of Full-thickness skin microcolumns implantation in Wound of Skin and Burns, sponsored by The Metis Foundation. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-08-13.
Sponsored by The Metis Foundation · Not applicable, Interventional, and Treatment
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 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.
905 studies on the registry are indexed under Burns; 164 are open to participants now.
This study's planned enrollment of 10 is below the median of 40 across 663 interventional studies indexed under Burns.
Browse Burns studies →The Metis Foundation is the lead sponsor of 12 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
implantation of FTSM on open wound
Procedure: Full-thickness skin microcolumns implantation
Surgical harvest and implantation of FTSM on an open wound requiring coverage.
Donor site re-epithelization between day 10 to 14
Donor site re-epithelization between day 10 to 14
Time frame: 10-14 days
Donor site
Assess donor site pigmentation, contraction, scar thickness and pain
Time frame: up to 6 months
Injured site
Assess injured site re-epithelization, pigmentation, contraction, scar thickness and pain
Time frame: up to 6 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Oct 2024 (actual). Primary completion is estimated for Dec 2026, 26 months after the start.
Of 210 non-industry interventional studies with no phase under Burns, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 38. This study's planned 26 months is above that.
Counting every sponsor, half of 239 studies reached it within 15 months; a quarter within 6 and three quarters within 38.
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The Metis Foundation