Status:
UNKNOWN
Microscopic Skin Tissue Column Grafting Technique Using the Autologous Regeneration of Tissue System
Lead Sponsor:
The Metis Foundation
Conditions:
Wound of Skin
Burns
Eligibility:
All Genders
18-70 years
Phase:
NA
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 stud...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05324514
Start Date
October 1 2022
End Date
December 1 2024
Last Update
August 25 2022
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.