Neoplasm of Skin | Use of the Epidermal Micrografts for Wound Healing After Mohs or Excisional Surgery for Skin Cancer
Neoplasm of Skin research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Neoplasm of Skin
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Momelan Technologies Epidermal Graft Harvesting SystemThe 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.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2012
Completed Date: July 2012
Primary Outcome: Wound healing/scarring
Secondary Outcome: Incidence of adverse events
Study sponsors, principal investigator, and references
Principal Investigator: Ashish C. Bhatia, MD
Lead Sponsor: Momelan Technologies