Microscopic Skin Tissue Column Grafting Technique Using the Autologous Regeneration of Tissue System

NCT05324514 | Unknown FDA Device

• 1 other identifier: ART-1
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates Microscopic Skin Tissue Column (MSTC) grafting technique using the Autologous Regeneration Tissue (ART) System in the treatment of skin loss. Each participant will have three study treated areas, the three treatments include: 1. traditional grafting, 2. high density MSTC, 3. low density MSTC.

Conditions

Wound of Skin; Burns

Outcome Measures

Primary Outcomes (4)

• Rate of healing

  The rate of healing of the donor sites will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.

  Day 7

• Rate of epithelialization

  The rate of epithelialization will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.

  Day 7

• Rate of healing

  The rate of healing of the donor sites will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.

  Day 14

• Rate of epithelialization

  The rate of epithelialization will be assessed utilizing clinical assessments and photography with 3D camera and the Silhouette Star wound camera.

  Day 14

Secondary Outcomes (9)

• Incidence of pain

  Day 3- Month 6

• Skin function

  Day 17- Month 6

• Presence of adnexal structures

  Day 30, Month 6

• Reepithelization

  Day 3- month 6

• Skin appearence

  Day 17- Month 6

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR

STSG grafting application.

Procedure: Split-thickness skin grafting

High Density

EXPERIMENTAL

MSTC high density application.

Device: High density microscopic skin tissue column grafting

Low Density

EXPERIMENTAL

MSTC low density application.

Device: Low density microscopic skin tissue column grafting

Interventions

Split-thickness skin grafting PROCEDURE

Harvesting for split-thickness skin grafting will be performed at the specified donor site using a pneumatically powered dermatome with a setting of 10 /1000th inch and meshed 2:1.

Standard of Care

High density microscopic skin tissue column grafting DEVICE

MSTC harvest will be conducted using the ART system (Medline Industries) in accordance with the manufacturer's instructions and distributed at high density (300-360 columns/50cm2).

High Density

Low density microscopic skin tissue column grafting DEVICE

MSTC harvest will be conducted using the ART system (Medline Industries) in accordance with the manufacturer's instructions and distributed at low density (150-180 columns/50cm2).

Low Density

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 and age less than or equal to 70.
• Skin loss from surgery, trauma, and/or burns.
• Presence of one uniform contiguous wound ≥150cm2
• Sufficient non-injured healthy skin from which conventional STSG can be harvested to cover study and non-study sites.
• Sufficient non-injured healthy skin from which the study device can be used to harvest MSTC to cover the study sites.
• Study donor site has not been previously harvested.
• Able and likely to follow-up, to have three consecutive appointments and appear for 6 month follow up visit.
• Subject agrees to abstain from enrollment in any other interventional clinical trial while enrolled in this study.

You may not qualify if:

• Exposure of tendon, bone devoid of peritenon or periosteum, or other structures deemed non-graftable by the treating physician or study investigator.
• Concomitant skin disease/infection at the recipient or donor sites.
• Use of topical steroid, anti-metabolite, or other pharmacologic therapy on study site.
• Use of systemic steroids in the past month.
• Concurrent conditions that in the opinion of the investigator may compromise subject safety, study objectives or wound healing.
• Current recipient of immunosuppressive therapy.
• Current treatment with medication that inhibit/compromise wound healing.
• Known history of malignancy.
• Pregnancy or lactation
• Prisoner
• History of noncompliance -\>40% total body surface area involvement.

Sponsors & Collaborators

• The Metis Foundation: lead

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Victoria Diaz, RN

CONTACT

210-569-1140; diaz@metisfoundationusa.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Formalin embedded biopsies will be sectioned and the sections will be stained. Stained tissue sections will be graded by blinded dermato-pathologists.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will have three wound sites that will be randomized to receive either the standard of care treatment, high density microscopic tissue skin columns, or low density microscopic tissue skin columns.

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: April 12, 2022
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share