NCT05223998

Manual Implantation of Full-Thickness Skin Microcolumns

Manual Implantation of Full-Thickness Skin Microcolumns for 'Donor-Free' Skin Renewal

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: The Metis Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Wound of Skin
• Burns

Interventions

Type	Name	Description
PROCEDURE	Full-thickness skin microcolumns implantation	Surgical harvest and implantation of FTSM on an open wound requiring coverage.

Timeline

• Start date: 2024-11-04
• Primary completion: 2025-09-29
• Completion: 2025-09-29
• First posted: 2022-02-04
• Last updated: 2024-10-18