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
35 Years
90 Years
Both
Neoplasm of Skin
Trial Information
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
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Wound healing/scarring
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
Ashish C. Bhatia, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
DuPage Medical Group
Authority:
United States: Institutional Review Board
Study ID:
MT-DMG-1
NCT ID:
NCT01536444
Start Date:
January 2012
Completion Date:
July 2012
Related Keywords:
- Neoplasm of Skin
- Mohs surgery
- Excisional skin surgery
- Micrografting
- Neoplasms
- Skin Neoplasms
Name | Location |
|---|---|
| DuPage Medical Group | Naperville, Illinois 60563 |
