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

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

NCT ID: NCT01536444

Condition: Neoplasm of Skin

Conditions: Official terms:
Skin Neoplasms

Conditions: Keywords:
Mohs surgery
Excisional skin surgery
Micrografting

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Momelan Technologies Epidermal Graft Harvesting System
Description: 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.
Arm group label: Micrografting

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.

Criteria for eligibility:
Criteria:
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.

Gender: All

Minimum age: 35 Years

Maximum age: 90 Years

Healthy volunteers: No

Locations:

Facility:
Name: DuPage Medical Group

Address:
City: Naperville
Zip: 60563
Country: United States

Status: Recruiting

Contact:
Last name: Ashish C. Bhatia, MD

Phone: 630-547-5040
Email: Ashish.Bhatia@Dupagemd.com

Contact backup:
Last name: Peri Todd

Phone: 630-942-7956
Email: Peri.Todd@Dupagemd.com

Investigator:
Last name: Ashish C. Bhatia, MD
Email: Principal Investigator

Start date: January 2012

Completion date: July 2012

Lead sponsor:
Agency: Momelan Technologies
Agency class: Industry

Source: Momelan Technologies

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01536444