Use of the Epidermal Micrografts for Wound Healing After Mohs or Excisional Surgery for Skin Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01536444
Recruitment Status : Unknown
Verified February 2012 by Momelan Technologies.
Recruitment status was:  Recruiting
First Posted : February 22, 2012
Last Update Posted : February 22, 2012
Information provided by (Responsible Party):
Momelan Technologies

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.

Condition or disease Intervention/treatment
Neoplasm of Skin Device: Momelan Technologies Epidermal Graft Harvesting System

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Use of the Epidermal Expansion System to Harvest and Place Suction Blister Epidermal Grafts on Wounds in Patients After Mohs or Excisional Surgery for Skin Cancer
Study Start Date : January 2012
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Micrografting Device: 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 Measures :
  1. Wound healing/scarring [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 6 weeks ]
  2. Physician global satisfaction [ Time Frame: 6 weeks ]
  3. Subject global satisfaction [ Time Frame: 6 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01536444

Contact: Robert LaRoche 978-376-2879

United States, Illinois
DuPage Medical Group Recruiting
Naperville, Illinois, United States, 60563
Contact: Ashish C. Bhatia, MD    630-547-5040   
Contact: Peri Todd    630-942-7956   
Principal Investigator: Ashish C. Bhatia, MD         
Sponsors and Collaborators
Momelan Technologies
Principal Investigator: Ashish C. Bhatia, MD DuPage Medical Group

Responsible Party: Momelan Technologies Identifier: NCT01536444     History of Changes
Other Study ID Numbers: MT-DMG-1
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: February 22, 2012
Last Verified: February 2012

Keywords provided by Momelan Technologies:
Mohs surgery
Excisional skin surgery

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Skin Diseases