Manual Implantation of Full-Thickness Skin Microcolumns
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-85
SponsorThe Metis Foundation
About this trial
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 an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Wound area involving the face*
Wound area involving joints*
Pregnancy
Prisoner
Trial design
Design model
Single group
Treatments tested in this trial
Full-thickness skin microcolumns implantation
Procedure/SurgerySurgical harvest and implantation of FTSM on an open wound requiring coverage.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Full-thickness skin microcolumns ImplantationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Donor site re-epithelization between day 10 to 14
Donor site re-epithelization between day 10 to 14
Time frame
10-14 daysSecondary outcomes
1
Donor site
Assess donor site pigmentation, contraction, scar thickness and pain
Time frame
up to 6 months2
Injured site
Assess injured site re-epithelization, pigmentation, contraction, scar thickness and pain
Time frame
up to 6 monthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: