Manual Implantation of Full-Thickness Skin Microcolumns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-04

Study Completion Date

2025-09-29

Brief Summary

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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.

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Detailed Description

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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

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Wound of Skin Burns

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Proof of concept

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Full-thickness skin microcolumns Implantation

implantation of FTSM on open wound

Group Type EXPERIMENTAL

Full-thickness skin microcolumns implantation

Intervention Type PROCEDURE

Surgical harvest and implantation of FTSM on an open wound requiring coverage.

Interventions

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Full-thickness skin microcolumns implantation

Surgical harvest and implantation of FTSM on an open wound requiring coverage.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No