Back to resultsUse of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds
Primary Purpose
Surgical Wound, Hypo-pigmented Skin
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Momelan Technologies Epidermal Graft Harvesting System
Sponsored by
About this trial
This is an interventional treatment trial for Surgical Wound focused on measuring Skin surgery, Micrografting, Hypo-pigmentation
Eligibility Criteria
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
Sites / Locations
- Laser and Skin Surgery Center of New YorkRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Micrografting
Arm Description
Outcomes
Primary Outcome Measures
Wound healing/pigmentation
Secondary Outcome Measures
Patient Satisfaction
Physician Satisfaction
Incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01590329
Brief Title
Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Momelan Technologies
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgical Wound, Hypo-pigmented Skin
Keywords
Skin surgery, Micrografting, Hypo-pigmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Micrografting
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Momelan Technologies Epidermal Graft Harvesting System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wound healing/pigmentation
Time Frame
up to 12 weeks
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Time Frame
6-12 weeks
Title
Physician Satisfaction
Time Frame
6-12 weeks
Title
Incidence of adverse events
Time Frame
6-12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robert LaRoche
Phone
978-376-2879
Email
robert.laroche@momelan.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Geronemus, MD
Organizational Affiliation
Laser and Skin Surgery Center of New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laser and Skin Surgery Center of New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roy Geronemus, MD
Phone
212-686-7306
Email
rgeronemus@laserskinsurgery.com
First Name & Middle Initial & Last Name & Degree
Jennifer Moreno
Phone
212-686-7306
Ext
608
Email
jmoreno@laserskinsurgery.com
First Name & Middle Initial & Last Name & Degree
Roy Geronemus, MD
12. IPD Sharing Statement
Learn more about this trial
Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds
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