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

M

Momelan Technologies

Status

Unknown

Conditions

Neoplasm of Skin

Treatments

Device: Momelan Technologies Epidermal Graft Harvesting System

Study type

Interventional

Funder types

Industry

Identifiers

NCT01536444
MT-DMG-1

Details and patient eligibility

About

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.

Full 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.

Enrollment

12 estimated patients

Sex

All

Ages

35 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

Micrografting
Experimental group
Treatment:
Device: Momelan Technologies Epidermal Graft Harvesting System

Trial contacts and locations

1

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Central trial contact

Robert LaRoche

Data sourced from clinicaltrials.gov

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