Burns, Wound of Skin
Conditions
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.
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
PROCEDUREFull-thickness skin microcolumns implantation
Surgical harvest and implantation of FTSM on an open wound requiring coverage.
Sponsors
The Metis Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Proof of concept
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Donor site re-epithelization between day 10 to 14 | 10-14 days | Donor site re-epithelization between day 10 to 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Donor site | up to 6 months | Assess donor site pigmentation, contraction, scar thickness and pain |
| Injured site | up to 6 months | Assess injured site re-epithelization, pigmentation, contraction, scar thickness and pain |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRodney Chan, MD
Metis Foundation
Outcome results
None listed