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

Sponsor

Momelan Technologies (Industry)

Overall Status

Unknown status

CT.gov ID

NCT01590329

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Surgical Wound Hypo-pigmented Skin	Device: Momelan Technologies Epidermal Graft Harvesting System	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2012

Anticipated Primary Completion Date :

Oct 1, 2012

Anticipated Study Completion Date :

Oct 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Micrografting	Device: 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.

Arm

Intervention/Treatment

Experimental: Micrografting

Device: 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.

Outcome Measures

Primary Outcome Measures

Wound healing/pigmentation [up to 12 weeks]

Secondary Outcome Measures

Patient Satisfaction [6-12 weeks]
Physician Satisfaction [6-12 weeks]
Incidence of adverse events [6-12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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