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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-10-31

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.

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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.

Conditions

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Surgical Wound Hypo-pigmented Skin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Micrografting

Group Type EXPERIMENTAL

Momelan Technologies Epidermal Graft Harvesting System

Intervention Type 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.

Interventions

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Momelan Technologies Epidermal Graft Harvesting System

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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No