Manual Implantation of Full-Thickness Skin Microcolumns

Not Applicable

Not yet recruiting

• Conditions: Wound of Skin; Burns
• Interventions: Procedure: Full-thickness skin microcolumns implantation

• Registration Number: NCT05223998
• Lead Sponsor: The Metis Foundation

Brief 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.

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2022-01-31
• Study First Posted: 2022-02-04
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-18
• Study Start: 2024-11-04
• Primary Completion: 2025-09-29
• Study Completion: 2025-09-29

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Full-thickness skin microcolumns Implantation	Full-thickness skin microcolumns implantation	implantation of FTSM on open wound

Primary Outcome Measures

Name	Time	Method
Donor site re-epithelization between day 10 to 14	10-14 days	Donor site re-epithelization between day 10 to 14

Secondary Outcome Measures

Name	Time	Method
Donor site	up to 6 months	Assess donor site pigmentation, contraction, scar thickness and pain
Injured site	up to 6 months	Assess injured site re-epithelization, pigmentation, contraction, scar thickness and pain