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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


N/A
35 Years
90 Years
Open (Enrolling)
Both
Neoplasm of Skin

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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 GroupNaperville, Illinois  60563