Recruiting

Epidermal Micrografts

Sponsor:

Momelan Technologies

Code:

NCT01536444

Conditions

Neoplasm of Skin

Eligibility Criteria

Sex: All

Age: 35 - 70+

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 that have wounds from Mohs or excisional surgery.

Conditions

Neoplasm of Skin

Study ID

NCT01536444

Start date

Jan, 2012

Status verified date

Feb, 2012

Completion date

Jul, 2012

Anticipated

Primary completion date

Jul, 2012

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 35 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Adult males and females between 35 and 90 years of age
  • Status post skin cancer removal on the scalp, ear or leg with a wound that would otherwise be allowed to heal by secondary intention or grafting
  • Wound considered appropriate by physician to receive epidermal grafting
  • Willingness to participate in study by evidence of informed consent

Exclusion Criteria:

  • Female patients reported to be breastfeeding, pregnant or planning to become pregnant
  • Clinical signs of infection
  • Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
  • Participation in another interventional study with potential exposure to an investigational drug or device within the past 30 days or planned study entry within 90 days after study entrance.

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 micrograft involves the use of the MoMelan Technologies suction blister system which consists of a control box that creates the vacuum necessary to create the microblisters and a harvester. The device is applied to the subject's thigh to create blisters. The epidermal micrografts are then harvested and transferred to Tegaderm™ and then placed on the surgical wound and the wound is bandaged.

Primary outcome measure

  • Wound healing/scarring [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Robert LaRoche

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

Locations

DuPage Medical Group

Recruiting

Naperville, Illinois, United States, 60563

Contacts

Ashish C. Bhatia, MD

630-547-5040Ashish.Bhatia@Dupagemd.com

Peri Todd

630-942-7956Peri.Todd@Dupagemd.com

Principal Investigator:

Ashish C. Bhatia, MD

More Information

Sponsor

Momelan Technologies

Last update posted

Feb 22, 2012

Last verified

Feb, 2012

Keywords

  • Mohs surgery
  • Excisional skin surgery
  • Micrografting

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Momelan Technologies on 2012-02-22.