Status:
NOT_YET_RECRUITING
Manual Implantation of Full-Thickness Skin Microcolumns
Lead Sponsor:
The Metis Foundation
Conditions:
Wound of Skin
Burns
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The objective of this study is to validate the proof of concept regarding the approach of manual implantation of full-thickness skin microcolumns (FTSMs) as coverage for open wounds without creating a...
Detailed Description
Previously three patients have been successfully treated with the use of manual FTSM for wound coverage. To provide additional proof of concept data, this study will validate manual FTSM implantation ...
Eligibility Criteria
Inclusion
- 8-85 years of age
- 10-125 cm2 open wound on the scalp, neck, torso or extremities necessitating tissue coverage
- Sufficiently healthy skin to serve as a donor site
Exclusion
- Wound area involving the face\*
- Wound area involving joints\*
- Pregnancy
- Prisoner
- Active wound infection at potential treatment sites
- Exposed muscle, joint, tendon, or bone within the wound bed
Key Trial Info
Start Date :
November 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 29 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05223998
Start Date
November 4 2024
End Date
September 29 2025
Last Update
October 18 2024
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