Manual Implantation of Full-Thickness Skin Microcolumns
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Full-thickness skin microcolumns implantation.
- Who it may be relevant to
- Registry conditions: Wound of Skin, Burns. Basic parameters: 18 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Manual Implantation of Full-Thickness Skin Microcolumns for 'Donor-Free' Skin Renewal
Overview
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.
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 on a larger scale with a 10-patient population. This will be measured by the following hypothesized parameters: time to re-epithelization, pigmentation, wound contraction, scar thickness, pain at the donor site and injury site healing outcome. The approach to testing this hypothesis will be to perform manual FTSM harvest, placement on the injured site, covered by an inert dressing for 10 patients with open wounds necessitating tissue coverage. The rationale is that although preliminary proof of concept data has already been obtained from three patients treated with FTSM implantation, additional proof of concept data would strengthen the conclusions made based on these cases.
Interventions
- Procedure Full-thickness skin microcolumns implantation
Surgical harvest and implantation of FTSM on an open wound requiring coverage.
Primary outcome measures
- Donor site re-epithelization between day 10 to 14 [Time frame: 10-14 days]
Secondary outcome measures (2)
- Donor site [Time frame: up to 6 months]
- Injured site [Time frame: up to 6 months]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT05223998 · Pro00071475 · CDMRP-MB200033