View Clinical Trial (Medical Research Study)
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
| City: |
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Naperville |
| State: |
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Illinois |
| Zip Code: |
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60563 |
| Conditions: |
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Neoplasm of Skin |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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.
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| NCT ID: |
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NCT01536444 |
| Primary Contact: |
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Principal Investigator
Ashish C. Bhatia, MD
DuPage Medical Group
Robert LaRoche
Phone: 978-376-2879
Email: robert.laroche@momelan.com
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| Backup Contact: |
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N/A |
| Location Contact: |
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Naperville, Illinois 60563
United States
Ashish C. Bhatia, MD
Phone: 630-547-5040
Email: Ashish.Bhatia@Dupagemd.com
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 20, 2013 |
| Modifications to this listing: |
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