Wound of SkinNCT05223998
Manual Implantation of Full-Thickness Skin Microcolumns
A study testing Full-thickness skin microcolumns implantation in people with Wound of Skin and Burns, run by The Metis Foundation at 1 site in United States.
Trial 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 an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Wound of Skin, Burns
- What is being tested?
- Full-thickness skin microcolumns implantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Oct 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The Center for Ambulatory Surgery of America
San Antonio, Texas, 78229
About this study
Official title: Manual Implantation of Full-Thickness Skin Microcolumns for 'Donor-Free' Skin Renewal
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.
Read the 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.
- Conditions
- Wound of Skin, Burns
- Being tested
- Full-thickness skin microcolumns implantation
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full-thickness skin microcolumns implantationProcedure or surgery
Surgical harvest and implantation of FTSM on an open wound requiring coverage.
| Study group | Role | What they receive |
|---|---|---|
| Full-thickness skin microcolumns Implantation | Experimental | implantation of FTSM on open wound Receives: Procedure: Full-thickness skin microcolumns implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Donor site re-epithelization between day 10 to 14
Donor site re-epithelization between day 10 to 14
Measured: 10-14 days
Secondary outcomes (2)
Donor site
Assess donor site pigmentation, contraction, scar thickness and pain
Measured: up to 6 months
Injured site
Assess injured site re-epithelization, pigmentation, contraction, scar thickness and pain
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2022
- Study start28 Oct 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wound of SkinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Proof of concept
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Metis Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rodney Chan, MD, Principal investigator, Metis Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05223998
- Sponsor's protocol ID
- Pro00071475
- Other IDs
- CDMRP-MB200033
- Status last verified
- Aug 2026
- First submitted
- 20 Oct 2021
- Last updated
- 13 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Manual Implantation of Full-Thickness Skin Microcolumns for 'Donor-Free' Skin Renewal
- ClinicalTrials.gov ID
- NCT05223998
- Acronym / sponsor ID
- Pro00071475
- Conditions
- Wound of Skin, Burns
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Metis FoundationUniversity, hospital or other
- Study start
- 28 Oct 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Proof of concept
| Arm | Type | Receives |
|---|---|---|
| Full-thickness skin microcolumns Implantation | Experimental | Procedure: Full-thickness skin microcolumns implantationimplantation of FTSM on open wound |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- Wound area involving the face*
- Wound area involving joints*
- Pregnancy
- Prisoner
- Active wound infection at potential treatment sites
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full-thickness skin microcolumns implantationSurgical harvest and implantation of FTSM on an open wound requiring coverage. | Procedure or surgery | Full-thickness skin microcolumns Implantation |
Primary outcome
Donor site re-epithelization between day 10 to 14
Time frame: 10-14 days
Donor site re-epithelization between day 10 to 14
2 secondary outcomes
Donor site
Time frame: up to 6 months
Injured site
Time frame: up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rodney Chan, MD principal investigator
Metis Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full-thickness skin microcolumns implantation in people with Wound of Skin and Burns, run by The Metis Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Donor site re-epithelization between day 10 to 14 (time frame: 10-14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.