Manual Implantation of Full-Thickness Skin Microcolumns

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Burns; Wound of Skin
• Intervention / Treatment: Procedure: Full-thickness skin microcolumns implantation

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Victoria Diaz, RN; Phone Number: 2105691140; Email: Diaz@metisfoundationusa.org
• Study Contact Backup: Name: Kristin Anselmo, RN; Email: kanselmo@metisfoundationusa.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Full-thickness skin microcolumns Implantation; implantation of FTSM on open wound	Procedure: Full-thickness skin microcolumns implantation; Surgical harvest and implantation of FTSM on an open wound requiring coverage.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Donor site re-epithelization between day 10 to 14	Donor site re-epithelization between day 10 to 14	10-14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Donor site	Assess donor site pigmentation, contraction, scar thickness and pain	up to 6 months
Injured site	Assess injured site re-epithelization, pigmentation, contraction, scar thickness and pain	up to 6 months

Collaborators and Investigators

• Sponsor: The Metis Foundation
• Investigators: Principal Investigator: Rodney Chan, MD, Metis Foundation

Study record dates

Study Major Dates

• Study Start (Estimated): November 4, 2024
• Primary Completion (Estimated): September 29, 2025
• Study Completion (Estimated): September 29, 2025

Study Registration Dates

• First Submitted: October 20, 2021
• First Submitted That Met QC Criteria: January 31, 2022
• First Posted (Actual): February 4, 2022

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 17, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: Pro00071475; CDMRP-MB200033 (Other Grant/Funding Number: Congressionally Directed Medical Research Program Office)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No