Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds

Not Applicable

• Conditions: Surgical Wound; Hypo-pigmented Skin

• Registration Number: NCT01590329
• 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 with hypo pigmented skin or surgical skin wounds.

Detailed Description

This study evaluates a novel micrografting technique to determine how it will influence the repigmentation of selected areas of hypopigmentation, and how it will influence the healing and pigmentation of surgical skin wounds. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile FDA cleared wound dressing for application to the subject's acute wound or prepared recipient site. The sponsor hypothesizes that applying expanded micrografts to target sites will result in rapid healing of acute wounds and in repigmentation of hypopigmented skin as well as and provide improved cosmetic outcomes.

Study Timeline

• Study Start: 2012-03
• Status Verified: 2012-05
• Study First Submitted: 2012-05-01
• Study First Submitted QC: 2012-05-01
• Last Update Submitted: 2012-05-01
• Study First Posted: 2012-05-02
• Last Update Posted: 2012-05-02
• Primary Completion: 2012-10
• Study Completion: 2012-10

Recruitment & Eligibility

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

Inclusion Criteria

• Male or female adult subject between 18 and 99 years of age
• Subject having an area of hypopigmentation or surgical wound considered appropriate by physician to receive epidermal micro grafting
• Willingness to participate in study by evidence of informed consent

Exclusion Criteria

• Female subjects self-reported to be breastfeeding, pregnant or planning to become pregnant during the course of the study.
• Subject showing clinical signs of infection
• Subjects currently on immunosuppressive medications, chemotherapy or cytotoxic agents
• Subject participation in another interventional study with potential exposure to an investigational drug or device within the past 30 days or planned entry into another investigational study within 90 days after entrance into this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Wound healing/pigmentation	up to 12 weeks

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction	6-12 weeks
Physician Satisfaction	6-12 weeks
Incidence of adverse events	6-12 weeks

Trial Locations

Locations (1)

Laser and Skin Surgery Center of New York; 🇺🇸 New York, New York, United States