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

This study is currently recruiting participants.
Verified May 2012 by Momelan Technologies
Sponsor:
Information provided by (Responsible Party):
Momelan Technologies
ClinicalTrials.gov Identifier:
NCT01590329
First received: May 1, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

Further study details as provided by Momelan Technologies:

Primary Outcome Measures:
  • Wound healing/pigmentation [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient Satisfaction [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]
  • Physician Satisfaction [ Time Frame: 6-12 weeks ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: 6-12 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Momelan Technologies
ClinicalTrials.gov Identifier: NCT01590329     History of Changes
Other Study ID Numbers: MMT-LSS-1
Study First Received: May 1, 2012
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hypopigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013