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

Neoplasm of Skin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01536444
• Other study ID #: MT-DMG-1
• Status: Recruiting
• Phase: N/A
• First received: February 16, 2012
• Last updated: February 21, 2012
• Start date: January 2012
• Est. completion date: July 2012

Study information

• Verified date: February 2012
• Source: Momelan Technologies
• Contact: Robert LaRoche
• Phone: 978-376-2879
• Email: robert.laroche[@]momelan.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 90 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neoplasm of Skin
• Skin Neoplasms

Intervention

Device:
• Momelan Technologies Epidermal Graft Harvesting System
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.

Locations

Country	Name	City	State
United States	DuPage Medical Group	Naperville	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Momelan Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing/scarring		6 weeks	No
Secondary	Incidence of adverse events		6 weeks	Yes
Secondary	Physician global satisfaction		6 weeks	No
Secondary	Subject global satisfaction		6 weeks	No