Hypo-pigmented Skin, Surgical Wound
Conditions
Keywords
Skin surgery, Micrografting, Hypo-pigmentation
Brief summary
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.
Detailed description
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.
Interventions
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.
Sponsors
Momelan Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing/pigmentation | up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Patient Satisfaction | 6-12 weeks |
| Physician Satisfaction | 6-12 weeks |
| Incidence of adverse events | 6-12 weeks |
Countries
United States
Contacts
Primary ContactRobert LaRoche
Outcome results
None listed