Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds
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
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2012
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 1, 2012
CompletedFirst Posted
Study publicly available on registry
May 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedMay 2, 2012
May 1, 2012
7 months
May 1, 2012
May 1, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Wound healing/pigmentation
up to 12 weeks
Secondary Outcomes (3)
Patient Satisfaction
6-12 weeks
Physician Satisfaction
6-12 weeks
Incidence of adverse events
6-12 weeks
Study Arms (1)
Micrografting
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laser and Skin Surgery Center of New York
New York, New York, 10016, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Roy Geronemus, MD
Laser and Skin Surgery Center of New York
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 1, 2012
First Posted
May 2, 2012
Study Start
March 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
May 2, 2012
Record last verified: 2012-05