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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Neoplasm of Skin

Intervention / Treatment
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* Device: Momelan Technologies Epidermal Graft Harvesting System


Participation Criteria
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Eligibility 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.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micrografting<br> | Device: Momelan Technologies Epidermal Graft Harvesting System<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing/scarring |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events |  | 6 weeks | 
| Physician global satisfaction |  | 6 weeks | 
| Subject global satisfaction |  | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mohs surgery, Excisional skin surgery, Micrografting