Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds
Status: | Completed |
---|---|
Conditions: | Dermatology |
Therapuetic Areas: | Dermatology / Plastic Surgery |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/2/2016 |
Start Date: | March 2012 |
End Date: | October 2012 |
Contact: | Robert LaRoche |
Email: | robert.laroche@momelan.com |
Phone: | 978-376-2879 |
A Proof of Concept Cases Series on the Use of the Epidermal Expansion System to Harvest and Place Suction Blister Epidermal Grafts on Hypopigmented Skin and Surgical Wounds
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.
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.
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.
Inclusion Criteria:
- Male or female adult subject between 18 and 99 years of age
- Subject having an area of hypopigmentation or surgical wound considered appropriate
by physician to receive epidermal micro grafting
- Willingness to participate in study by evidence of informed consent
Exclusion Criteria:
- Female subjects self-reported to be breastfeeding, pregnant or planning to become
pregnant during the course of the study.
- Subject showing clinical signs of infection
- Subjects currently on immunosuppressive medications, chemotherapy or cytotoxic agents
- Subject participation in another interventional study with potential exposure to an
investigational drug or device within the past 30 days or planned entry into another
investigational study within 90 days after entrance into this study
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