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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micrografting | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Momelan Technologies Epidermal Graft Harvesting System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Wound healing/scarring | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events | 6 weeks | |
| Physician global satisfaction | 6 weeks | |
| Subject global satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Robert LaRoche | Contact | 978-376-2879 | robert.laroche@momelan.com |
| Name | Affiliation | Role |
|---|---|---|
| Ashish C. Bhatia, MD | DuPage Medical Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DuPage Medical Group | Recruiting | Naperville | Illinois | 60563 | United States |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| 6 weeks |