Manual Implantation of Full-Thickness Skin Microcolumns

The Metis Foundation

Status: Not yet enrolling

Conditions: Wound of Skin; Burns

Treatments: Procedure: Full-thickness skin microcolumns implantation

Study type: Interventional

Funder types: Other

Identifiers

NCT05223998

Pro00071475

CDMRP-MB200033 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Full-thickness skin microcolumns Implantation

Experimental group

Description:

implantation of FTSM on open wound

Treatment:

Procedure: Full-thickness skin microcolumns implantation