Surgical WoundNCT01590329
Use of Epidermal Expansion System for Epidermal Grafting on Hypopigmented Skin and Surgical Wounds
A study testing Momelan Technologies Epidermal Graft Harvesting System in people with Surgical Wound and Hypo-pigmented Skin, run by Momelan Technologies at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgical Wound, Hypo-pigmented Skin
- What is being tested?
- Momelan Technologies Epidermal Graft Harvesting System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2012to Oct 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Laser and Skin Surgery Center of New York
New York, New York, 10016
Roy Geronemus, MD, 212-686-7306, rgeronemus@laserskinsurgery.com
Jennifer Moreno, 212-686-7306 ext. 608, jmoreno@laserskinsurgery.com
About this study
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
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.
Read the 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.
- Conditions
- Surgical Wound, Hypo-pigmented Skin
- Being tested
- Momelan Technologies Epidermal Graft Harvesting System
- Keywords
- Skin surgery, Micrografting, Hypo-pigmentation
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Momelan Technologies Epidermal Graft Harvesting SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Micrografting | Experimental | Not described Receives: Device: Momelan Technologies Epidermal Graft Harvesting System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing/pigmentation
Measured: up to 12 weeks
Secondary outcomes (3)
Patient Satisfaction
Measured: 6-12 weeks
Physician Satisfaction
Measured: 6-12 weeks
Incidence of adverse events
Measured: 6-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012 (estimated)
- Study completionOct 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical WoundStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Momelan Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roy Geronemus, MD, Principal investigator, Laser and Skin Surgery Center of New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01590329
- Sponsor's protocol ID
- MMT-LSS-1
- Status last verified
- May 2012
- First submitted
- 1 May 2012
- Last updated
- 2 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01590329
- Acronym / sponsor ID
- MMT-LSS-1
- Conditions
- Surgical Wound, Hypo-pigmented Skin
- Keywords
- Skin surgery, Micrografting, Hypo-pigmentation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Momelan TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Oct 2012 (estimated)
- First posted
- 2 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micrografting | Experimental | Device: Momelan Technologies Epidermal Graft Harvesting System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Momelan Technologies Epidermal Graft Harvesting SystemThe 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. | Device | Micrografting |
Primary outcome
Wound healing/pigmentation
Time frame: up to 12 weeks
3 secondary outcomes
Patient Satisfaction
Time frame: 6-12 weeks
Physician Satisfaction
Time frame: 6-12 weeks
Incidence of adverse events
Time frame: 6-12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Geronemus, MD principal investigator
Laser and Skin Surgery Center of New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Momelan Technologies Epidermal Graft Harvesting System in people with Surgical Wound and Hypo-pigmented Skin, run by Momelan Technologies at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 May 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert LaRoche (978-376-2879, robert.laroche@momelan.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wound healing/pigmentation (time frame: up to 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2012.