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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by Momelan Technologies.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Momelan Technologies
ClinicalTrials.gov Identifier:
NCT01536444
First received: February 16, 2012
Last updated: February 21, 2012
Last verified: February 2012
  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.


Condition Intervention
Neoplasm of Skin
Device: Momelan Technologies Epidermal Graft Harvesting System

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Momelan Technologies:

Primary Outcome Measures:
  • Wound healing/scarring [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Physician global satisfaction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Subject global satisfaction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: January 2012
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   35 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01536444

Contacts
Contact: Robert LaRoche 978-376-2879 robert.laroche@momelan.com

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

No publications provided

Responsible Party: Momelan Technologies
ClinicalTrials.gov Identifier: NCT01536444     History of Changes
Other Study ID Numbers: MT-DMG-1
Study First Received: February 16, 2012
Last Updated: February 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Momelan Technologies:
Mohs surgery
Excisional skin surgery
Micrografting

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

ClinicalTrials.gov processed this record on October 22, 2014