Use of the Epidermal Micrografts for Wound Healing After Mohs or Excisional Surgery for Skin Cancer
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
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
February 22, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2012
CompletedFebruary 22, 2012
February 1, 2012
6 months
February 16, 2012
February 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound healing/scarring
6 weeks
Secondary Outcomes (3)
Incidence of adverse events
6 weeks
Physician global satisfaction
6 weeks
Subject global satisfaction
6 weeks
Study Arms (1)
Micrografting
EXPERIMENTALInterventions
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 Tegadermâ„¢ and then placed on the surgical wound and the wound is bandaged.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
DuPage Medical Group
Naperville, Illinois, 60563, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ashish C. Bhatia, MD
DuPage Medical Group
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 16, 2012
First Posted
February 22, 2012
Study Start
January 1, 2012
Primary Completion
July 1, 2012
Study Completion
July 1, 2012
Last Updated
February 22, 2012
Record last verified: 2012-02