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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01590329
Recruitment Status : Unknown
Verified May 2012 by Momelan Technologies.
Recruitment status was:  Recruiting
First Posted : May 2, 2012
Last Update Posted : May 2, 2012
Information provided by (Responsible Party):
Momelan Technologies

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
Surgical Wound Hypo-pigmented Skin Device: Momelan Technologies Epidermal Graft Harvesting System

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
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 : March 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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.

Primary Outcome Measures :
  1. Wound healing/pigmentation [ Time Frame: up to 12 weeks ]

Secondary Outcome Measures :
  1. Patient Satisfaction [ Time Frame: 6-12 weeks ]
  2. Physician Satisfaction [ Time Frame: 6-12 weeks ]
  3. Incidence of adverse events [ Time Frame: 6-12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01590329

Contact: Robert LaRoche 978-376-2879

United States, New York
Laser and Skin Surgery Center of New York Recruiting
New York, New York, United States, 10016
Contact: Roy Geronemus, MD    212-686-7306   
Contact: Jennifer Moreno    212-686-7306 ext 608   
Principal Investigator: Roy Geronemus, MD         
Sponsors and Collaborators
Momelan Technologies
Principal Investigator: Roy Geronemus, MD Laser and Skin Surgery Center of New York

Responsible Party: Momelan Technologies Identifier: NCT01590329     History of Changes
Other Study ID Numbers: MMT-LSS-1
First Posted: May 2, 2012    Key Record Dates
Last Update Posted: May 2, 2012
Last Verified: May 2012

Keywords provided by Momelan Technologies:
Skin surgery

Additional relevant MeSH terms:
Wounds and Injuries
Surgical Wound
Pigmentation Disorders
Skin Diseases
Pathologic Processes