Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05324514 |
| Other study ID # |
ART-1 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2022 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
August 2022 |
| Source |
The Metis Foundation |
| Contact |
Victoria Diaz, RN |
| Phone |
210-569-1140 |
| Email |
diaz[@]metisfoundationusa.org |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
