Use of the Epidermal Micrografts for Wound Healing After Mohs or Excisional Surgery for Skin Cancer
Conditions
Neoplasm of Skin
Conditions: official terms
Skin Neoplasms
Conditions: Keywords
Mohs surgery, Excisional skin surgery, Micrografting
Study Type
Interventional
Study Phase
N/A
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Momelan Technologies Epidermal Graft Harvesting System
Type: Device
Overall Status
Recruiting
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.
Detailed Description
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 for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 35 Years
Gender: Both
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.
Location
DuPage Medical Group
Naperville, Illinois, United States
Status: Recruiting
Contact: Ashish C. Bhatia, MD - 630-547-5040 - Ashish.Bhatia@Dupagemd.com
Start Date
January 2012
Completion Date
July 2012
Sponsors
Momelan Technologies
Source
Momelan Technologies
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page