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This case series will assess the use of suction blister epidermal grafts harvested by a novel device on select patients with hypo pigmented skin or surgical skin wounds.
This study evaluates a novel micrografting technique to determine how it will influence the repigmentation of selected areas of hypopigmentation, and how it will influence the healing and pigmentation of surgical skin wounds. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile FDA cleared wound dressing for application to the subject's acute wound or prepared recipient site. The sponsor hypothesizes that applying expanded micrografts to target sites will result in rapid healing of acute wounds and in repigmentation of hypopigmented skin as well as and provide improved cosmetic outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micrografting | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Momelan Technologies Epidermal Graft Harvesting System | Device | The procurement of the epidermal micro graft involves the use of MoMelan Technologies suction blister system, which consists of a control harvester. The device is applied to the subject's thigh to create blisters. The epidermal micrografts are then harvested and transferred to a commercially available sterile film dressing, placed on the surgical wound or prepared recipient site and the wound is then bandaged. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing/pigmentation | up to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction | 6-12 weeks | |
| Physician Satisfaction | 6-12 weeks | |
| Incidence of adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert LaRoche | Contact | 978-376-2879 | robert.laroche@momelan.com |
| Name | Affiliation | Role |
|---|---|---|
| Roy Geronemus, MD | Laser and Skin Surgery Center of New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laser and Skin Surgery Center of New York | Recruiting | New York | New York | 10016 | United States |
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| ID | Term |
|---|---|
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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|
| 6-12 weeks |