Neoplasm of SkinNCT01536444
Use of the Epidermal Micrografts for Wound Healing After Mohs or Excisional Surgery for Skin Cancer
A study testing Momelan Technologies Epidermal Graft Harvesting System in people with Neoplasm of 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 that have wounds from Mohs or excisional surgery. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Neoplasm of 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
- Jan 2012to Jul 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 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult males and females between 35 and 90 years of age
- Status post skin cancer removal on the scalp, ear or leg with a wound that would otherwise be allowed to heal by secondary intention or grafting
- Wound considered appropriate by physician to receive epidermal grafting
- Willingness to participate in study by evidence of informed consent
Who cannot join
- Female patients reported to be breastfeeding, pregnant or planning to become pregnant
- Clinical signs of infection
- Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
- Participation in another interventional study with potential exposure to an investigational drug or device within the past 30 days or planned study entry within 90 days after study entrance.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
DuPage Medical Group
Naperville, Illinois, 60563
Ashish C. Bhatia, MD, 630-547-5040, Ashish.Bhatia@Dupagemd.com
Peri Todd, 630-942-7956, Peri.Todd@Dupagemd.com
About this study
Official title: Use of the Epidermal Expansion System to Harvest and Place Suction Blister Epidermal Grafts on Wounds in Patients After Mohs or Excisional Surgery for Skin Cancer
This case series will assess the use of suction blister epidermal grafts harvested by a novel device on select patients that have wounds from Mohs or excisional surgery.
Read the detailed description
This study evaluates a novel micrografting technique to determine how it will influence the healing and cosmetic result of selected post surgical wounds in 12 subjects. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile wound dressing for application to the subject's surgical area. The sponsor hypothesizes that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possibly reduce scarring.
- Conditions
- Neoplasm of Skin
- Being tested
- Momelan Technologies Epidermal Graft Harvesting System
- Keywords
- Mohs surgery, Excisional skin surgery, Micrografting
- Medical subject headings
- Skin Neoplasms
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 micrograft involves the use of the MoMelan Technologies suction blister system which consists of a control box that creates the vacuum necessary to create the microblisters and a harvester. The device is applied to the subject's thigh to create blisters. The epidermal micrografts are then harvested and transferred to Tegaderm™ and then placed on the surgical wound and the wound is 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/scarring
Measured: 6 weeks
Secondary outcomes (3)
Incidence of adverse events
Measured: 6 weeks
Physician global satisfaction
Measured: 6 weeks
Subject global satisfaction
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012 (estimated)
- Study completionJul 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neoplasm of SkinStudies 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
- Ashish C. Bhatia, MD, Principal investigator, DuPage Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01536444
- Sponsor's protocol ID
- MT-DMG-1
- Status last verified
- Feb 2012
- First submitted
- 16 Feb 2012
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of the Epidermal Expansion System to Harvest and Place Suction Blister Epidermal Grafts on Wounds in Patients After Mohs or Excisional Surgery for Skin Cancer
- ClinicalTrials.gov ID
- NCT01536444
- Acronym / sponsor ID
- MT-DMG-1
- Conditions
- Neoplasm of Skin
- Keywords
- Mohs surgery, Excisional skin surgery, Micrografting
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Momelan TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Jul 2012 (estimated)
- First posted
- 22 Feb 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 that have wounds from Mohs or excisional surgery.
Detailed description
This study evaluates a novel micrografting technique to determine how it will influence the healing and cosmetic result of selected post surgical wounds in 12 subjects. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile wound dressing for application to the subject's surgical area. The sponsor hypothesizes that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possibly reduce scarring.
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
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult males and females between 35 and 90 years of age
- Status post skin cancer removal on the scalp, ear or leg with a wound that would otherwise be allowed to heal by secondary intention or grafting
- Wound considered appropriate by physician to receive epidermal grafting
- Willingness to participate in study by evidence of informed consent
Key exclusion criteria (4 listed)
- Female patients reported to be breastfeeding, pregnant or planning to become pregnant
- Clinical signs of infection
- Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
- Participation in another interventional study with potential exposure to an investigational drug or device within the past 30 days or planned study entry within 90 days after study entrance.
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 micrograft involves the use of the MoMelan Technologies suction blister system which consists of a control box that creates the vacuum necessary to create the microblisters and a harvester. The device is applied to the subject's thigh to create blisters. The epidermal micrografts are then harvested and transferred to Tegaderm™ and then placed on the surgical wound and the wound is bandaged. | Device | Micrografting |
Primary outcome
Wound healing/scarring
Time frame: 6 weeks
3 secondary outcomes
Incidence of adverse events
Time frame: 6 weeks
Physician global satisfaction
Time frame: 6 weeks
Subject global satisfaction
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 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.
Ashish C. Bhatia, MD principal investigator
DuPage Medical Group
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 Neoplasm of 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 4 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 22 Feb 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/scarring (time frame: 6 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 22 Feb 2012.