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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Momelan Technologies.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590329
First Posted: May 2, 2012
Last Update Posted: May 3, 2012
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.
Information provided by (Responsible Party):
Momelan Technologies
  Purpose
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 Intervention
Surgical Wound Hypo-pigmented Skin Device: Momelan Technologies Epidermal Graft Harvesting System

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Momelan Technologies:

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

Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: 6-12 weeks ]
  • Physician Satisfaction [ Time Frame: 6-12 weeks ]
  • Incidence of adverse events [ Time Frame: 6-12 weeks ]

Estimated Enrollment: 12
Study Start Date: March 2012
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

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
Criteria

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01590329


Contacts
Contact: Robert LaRoche 978-376-2879 robert.laroche@momelan.com

Locations
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    rgeronemus@laserskinsurgery.com   
Contact: Jennifer Moreno    212-686-7306 ext 608    jmoreno@laserskinsurgery.com   
Principal Investigator: Roy Geronemus, MD         
Sponsors and Collaborators
Momelan Technologies
Investigators
Principal Investigator: Roy Geronemus, MD Laser and Skin Surgery Center of New York
  More Information

Responsible Party: Momelan Technologies
ClinicalTrials.gov Identifier: NCT01590329     History of Changes
Other Study ID Numbers: MMT-LSS-1
First Submitted: May 1, 2012
First Posted: May 2, 2012
Last Update Posted: May 3, 2012
Last Verified: May 2012

Keywords provided by Momelan Technologies:
Skin surgery
Micrografting
Hypo-pigmentation

Additional relevant MeSH terms:
Wounds and Injuries
Pigmentation Disorders
Hypopigmentation
Skin Diseases