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

Not Applicable

• Conditions: Neoplasm of Skin
• Interventions: Device: Momelan Technologies Epidermal Graft Harvesting System

• Registration Number: NCT01536444
• Lead Sponsor: Momelan Technologies

Brief 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.

Study Timeline

• Study Start: 2012-01
• Status Verified: 2012-02
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-21
• Last Update Submitted: 2012-02-21
• Study First Posted: 2012-02-22
• Last Update Posted: 2012-02-22
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Micrografting	Momelan Technologies Epidermal Graft Harvesting System	-

Primary Outcome Measures

Name	Time	Method
Wound healing/scarring	6 weeks

Secondary Outcome Measures

Name	Time	Method
Physician global satisfaction	6 weeks
Subject global satisfaction	6 weeks
Incidence of adverse events	6 weeks

Trial Locations

Locations (1)

DuPage Medical Group; 🇺🇸 Naperville, Illinois, United States