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

Momelan Technologies

Status

Unknown

Conditions

Hypo-pigmented Skin

Surgical Wound

Treatments

Device: Momelan Technologies Epidermal Graft Harvesting System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01590329

MMT-LSS-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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