Naperville, Illinois 60563

  • Neoplasm of Skin

Purpose:

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.


Study summary:

This study evaluates a novel micrografting technique to determine how it will influence the healing and cosmetic result of selected post surgical wounds in 12 subjects. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile wound dressing for application to the subject's surgical area. The sponsor hypothesizes that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possibly reduce scarring.


Criteria:

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.


NCT ID:

NCT01536444


Primary Contact:

Principal Investigator
Ashish C. Bhatia, MD
DuPage Medical Group

Robert LaRoche
Phone: 978-376-2879
Email: robert.laroche@momelan.com


Backup Contact:

N/A


Location Contact:

Naperville, Illinois 60563
United States

Ashish C. Bhatia, MD
Phone: 630-547-5040
Email: Ashish.Bhatia@Dupagemd.com

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 27, 2021

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