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

Launched by THE METIS FOUNDATION · Apr 5, 2022

Keywords

ClinConnect Summary

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 ...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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.
• Exclusion Criteria:
• • 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.