NCT05223998

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 an additional donor scar and while also capitalizing on the wound healing benefits offered by full-thickness skin grafts.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2024

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
2.8 years until next milestone

Study Start

First participant enrolled

November 4, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2025

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

11 months

First QC Date

October 20, 2021

Last Update Submit

October 17, 2024

Conditions

Wound of SkinBurns

Outcome Measures

Primary Outcomes (1)

  • Donor site re-epithelization between day 10 to 14

    Donor site re-epithelization between day 10 to 14

    10-14 days

Secondary Outcomes (2)

  • Donor site

    up to 6 months

  • Injured site

    up to 6 months

Study Arms (1)

Full-thickness skin microcolumns Implantation

EXPERIMENTAL

implantation of FTSM on open wound

Procedure: Full-thickness skin microcolumns implantation

Interventions

Full-thickness skin microcolumns implantationPROCEDURE

Surgical harvest and implantation of FTSM on an open wound requiring coverage.

Full-thickness skin microcolumns Implantation

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age
  • cm2 open wound on the scalp, neck, torso or extremities necessitating tissue coverage
  • Sufficiently healthy skin to serve as a donor site

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Rodney Chan, MD

    Metis Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Victoria Diaz, RN

CONTACT

2105691140diaz@metisfoundationusa.org

Kristin Anselmo, RN

CONTACT

kanselmo@metisfoundationusa.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Proof of concept
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2021

First Posted

February 4, 2022

Study Start

November 4, 2024

Primary Completion

September 29, 2025

Study Completion

September 29, 2025

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share