Clinical Trial: Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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
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 Summary: 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.
Sponsor: Momelan Technologies
Current Primary Outcome: Wound healing/pigmentation [ Time Frame: up to 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Patient Satisfaction [ Time Frame: 6-12 weeks ]
- Physician Satisfaction [ Time Frame: 6-12 weeks ]
- Incidence of adverse events [ Time Frame: 6-12 weeks ]
Original Secondary Outcome:
- Cosmesis [ Time Frame: 6-12 weeks ]
- Patient Satisfaction [ Time Frame: 6-12 weeks ]
- Physician Satisfaction [ Time Frame: 6-12 weeks ]
- Incidence of adverse events [ Time Frame: 6-12 weeks ]
Information By: Momelan Technologies
Dates:
Date Received: May 1, 2012
Date Started: March 2012
Date Completion: October 2012
Last Updated: May 1, 2012
Last Verified: May 2012
