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

Surgical Wound Clinical Trial

Official title:

A Proof of Concept Cases Series on the Use of the Epidermal Expansion System to Harvest and Place Suction Blister Epidermal Grafts on Hypopigmented Skin and Surgical Wounds

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01590329
• Other study ID #: MMT-LSS-1
• Status: Recruiting
• Phase: N/A
• First received: May 1, 2012
• Last updated: May 1, 2012
• Start date: March 2012
• Est. completion date: October 2012

Study information

• Verified date: May 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 with hypo pigmented skin or surgical skin wounds.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hypo-pigmented Skin
• Hypopigmentation
• Pigmentation Disorders
• Surgical Wound

Intervention

Device:
• Momelan Technologies Epidermal Graft Harvesting System
The procurement of the epidermal micro graft involves the use of MoMelan Technologies suction blister system, which consists of a control harvester. The device is applied to the subject's thigh to create blisters. The epidermal micrografts are then harvested and transferred to a commercially available sterile film dressing, placed on the surgical wound or prepared recipient site and the wound is then bandaged.

Locations

Country	Name	City	State
United States	Laser and Skin Surgery Center of New York	New York	New York

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/pigmentation		up to 12 weeks	No
Secondary	Patient Satisfaction		6-12 weeks	No
Secondary	Physician Satisfaction		6-12 weeks	No
Secondary	Incidence of adverse events		6-12 weeks	Yes