Neoplasm of Skin
Conditions
Keywords
Mohs surgery, Excisional skin surgery, Micrografting
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.
Detailed description
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.
Interventions
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.
Sponsors
Momelan Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wound healing/scarring | 6 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events | 6 weeks |
| Physician global satisfaction | 6 weeks |
| Subject global satisfaction | 6 weeks |
Countries
United States
Contacts
Primary ContactRobert LaRoche
Outcome results
None listed