NCT05324514

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

Full-Thickness Microscopic Skin Tissue Column Grafting Technique Using the ART (Autologous Regeneration Tissue) System: An Interventional Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: The Metis Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The current standard of care for coverage of large open wounds is split-thickness skin graft (STSG). These STSGs are typically harvested with a dermatome, which tangentially removes the epidermis and a thin layer of dermis from a healthy donor site. While relatively versatile, there are important limitations to STSGs. First, a healthy and readily accessible donor site is required prior to grafting. Second, each donor site itself becomes an open wound and is unable for grafting for approximately two weeks as the wound heals. To facilitate wound coverage, harvested STSG can be meshed up to a rate of 6:1 (though more common ratios are 1:1 and 2:1). However, widely meshed grafts tend to produce more severe scars and contractures, which represent tremendous long-term morbidity to the patient. The only means to avoid using widely meshed grafts is to harvest additional healthy donor skin, resulting in more pain from larger wound burdens and disfiguring scars in previously uninjured regions. Finally, STSG does not include deeper dermal structures such as hair follicles and sweat glands, and as such these grafts are both functionally and aesthetically substandard. Recently, skin microcolumn grafting has been proposed to address both skin graft donor site morbidity and long-term graft contracture. Specifically, the Autologous Regeneration of Tissue (ART)TM System, an FDA-cleared device, harvests full-thickness microscopic skin tissue columns (MSTC) orthogonally instead of tangentially; each skin column includes epidermis, dermis and associated adnexal structures, and subcutaneous fat. These MSTC cover an area up to 10x larger than the donor site (100:1 ratio, compared to up to 6:1 using STSG). Inclusion of adnexal structures results in improved wound-healing quality, less scarring, and a lower rate of secondary contracture. The small wounds caused by the ART system at the donor site during MSTC harvesting heal quickly and without the comorbidities associated with traditional harvesting. This autologous approach maintains low immunogenicity as no foreign or synthetic tissue is used as a skin substitute, which decreases the chance of infection or rejection in the wound bed. In short, the ART system allows for expansion of a donor site to a ratio of 1:100, faster healing of the donor site while still preserving donor site function, and improved healing of the original wound. The investigators will conduct a prospective, randomized controlled clinical trial comparing the MSTC grafting technique to the standard of care. Treatment sites will be randomized to either receiving MSTC or the traditional STSG. Objective measurements and assessments will be completed during subject follow-ups visits for up to six months.

Conditions

• Wound of Skin
• Burns

Interventions

Type	Name	Description
PROCEDURE	Split-thickness skin grafting	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.
DEVICE	High density microscopic skin tissue column grafting	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).
DEVICE	Low density microscopic skin tissue column grafting	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).

Timeline

• Start date: 2022-10-01
• Primary completion: 2024-10-01
• Completion: 2024-12-01
• First posted: 2022-04-12
• Last updated: 2022-08-25

Regulatory

• FDA-regulated device study