Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Surgical Wound, Hypo-pigmented Skin

Intervention / Treatment
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* Device: Momelan Technologies Epidermal Graft Harvesting System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micrografting<br> | Device: Momelan Technologies Epidermal Graft Harvesting System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing/pigmentation |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Satisfaction |  | 6-12 weeks | 
| Physician Satisfaction |  | 6-12 weeks | 
| Incidence of adverse events |  | 6-12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Skin surgery, Micrografting, Hypo-pigmentation