Recruiting

Epidermal Expansion

Sponsor:

Momelan Technologies

Code:

NCT01590329

Conditions

Surgical Wound

Hypo-pigmented Skin

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Momelan Technologies Epidermal Graft Harvesting System

Study Details

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.

Conditions

Surgical Wound

Hypo-pigmented Skin

Study ID

NCT01590329

Start date

Mar, 2012

Status verified date

May, 2012

Completion date

Oct, 2012

Anticipated

Primary completion date

Oct, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Micrografting

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Robert LaRoche

978-376-2879robert.laroche@momelan.com

Locations

Laser and Skin Surgery Center of New York

Recruiting

New York, New York, United States, 10016

Contacts

Roy Geronemus, MD

212-686-7306rgeronemus@laserskinsurgery.com

Jennifer Moreno

212-686-7306jmoreno@laserskinsurgery.com

Principal Investigator:

Roy Geronemus, MD

More Information

Sponsor

Momelan Technologies

Last update posted

May 2, 2012

Last verified

May, 2012

Keywords

  • Skin surgery
  • Micrografting
  • Hypo-pigmentation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Momelan Technologies on 2012-05-02.