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

May 1, 2012
May 1, 2012
March 2012
October 2012   (final data collection date for primary outcome measure)
Wound healing/pigmentation [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds
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

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.

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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Surgical Wound
  • Hypo-pigmented Skin
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.
Experimental: Micrografting
Intervention: Device: Momelan Technologies Epidermal Graft Harvesting System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
October 2012
October 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Robert LaRoche 978-376-2879 robert.laroche@momelan.com
United States
 
NCT01590329
MMT-LSS-1
No
Momelan Technologies
Momelan Technologies
Not Provided
Principal Investigator: Roy Geronemus, MD Laser and Skin Surgery Center of New York
Momelan Technologies
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP