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

Status Recruiting

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.

Clinical Trial 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 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

• NCT number: NCT01590329
• Study type: Interventional
• Source: Momelan Technologies
• Contact: Robert LaRoche
• Phone: 978-376-2879
• Email: robert.laroche@momelan.com
• Status: Recruiting
• Phase: N/A
• Start date: March 2012
• Completion date: October 2012