An interventional study of Split-thickness skin grafting and High density microscopic skin tissue column grafting in Wound of Skin and Burns, sponsored by The Metis Foundation. Status unknown. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-08-25.
Sponsored by The Metis Foundation · Not applicable, Interventional, and Treatment
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.
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.
The Metis Foundation is the lead sponsor of 12 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
STSG grafting application.
Procedure: Split-thickness skin grafting
MSTC high density application.
Device: High density microscopic skin tissue column grafting
MSTC low density application.
Device: Low density microscopic skin tissue column 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.
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).
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).
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Day 14
Incidence of pain
Donor sites will be assessed for incidence and level of pain experienced.
Time frame: Day 3- Month 6
Skin function
Skin function as measures by the validated Patient and Observer Scar Assessment Scale. The Patient and Observer Scar Assessment scale uses a 0-10 scale 0 being normal appearance, 10 being the worst possible outcome (POSAS).
Time frame: Day 17- Month 6
Presence of adnexal structures
Presence of adnexal structures will be assessed by obtaining a wound biopsy.
Time frame: Day 30, Month 6
Reepithelization
Clinical assessment for the need to re-graft treatment sites.
Time frame: Day 3- month 6
Skin appearence
Skin appearance measured using Vancouver Scar Scale (VSS). VSS rates Vascularity, pigmentation, pliability, and hight of the affected skin using a numeric scale to get an overall total of 1-13.
Time frame: Day 17- Month 6
Skin pliability
Skin pliability measured using a Dermal torque meter (DTM).
Time frame: Day 17- Month 6
Skin integrity
Skin integrity measured by a tewameter. The tewameter is a measuring device for the assessment of the trans-epidermal water loss (TEWL).
Time frame: Day 17- Month 6
Skin pressure
Skin pressure measured using a semmes-weinstein aesthesiometer
Time frame: Day 17- Month 6
Skin color
Skin color to be measured using colorimeter.
Time frame: Day 17- Month 6
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.
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