Trial record 8 of 75 for:
Open Studies | "Skin Neoplasms"
Use of the Epidermal Micrografts for Wound Healing After Mohs or Excisional Surgery for Skin Cancer
This study is currently recruiting participants.
Verified February 2012 by Momelan Technologies
Sponsor:
Momelan Technologies
Information provided by (Responsible Party):
Momelan Technologies
ClinicalTrials.gov Identifier:
NCT01536444
First received: February 16, 2012
Last updated: February 21, 2012
Last verified: February 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Neoplasm of Skin |
Device: Momelan Technologies Epidermal Graft Harvesting System |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Momelan Technologies:
Primary Outcome Measures:
- Wound healing/scarring [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
- Physician global satisfaction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
- Subject global satisfaction [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 12 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Micrografting |
Device: Momelan Technologies Epidermal Graft Harvesting System
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.
|
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.
Eligibility| Ages Eligible for Study: | 35 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01536444
Contacts
| Contact: Robert LaRoche | 978-376-2879 | robert.laroche@momelan.com |
Locations
| United States, Illinois | |
| DuPage Medical Group | Recruiting |
| Naperville, Illinois, United States, 60563 | |
| Contact: Ashish C. Bhatia, MD 630-547-5040 Ashish.Bhatia@Dupagemd.com | |
| Contact: Peri Todd 630-942-7956 Peri.Todd@Dupagemd.com | |
| Principal Investigator: Ashish C. Bhatia, MD | |
Sponsors and Collaborators
Momelan Technologies
Investigators
| Principal Investigator: | Ashish C. Bhatia, MD | DuPage Medical Group |
More Information
No publications provided
| Responsible Party: | Momelan Technologies |
| ClinicalTrials.gov Identifier: | NCT01536444 History of Changes |
| Other Study ID Numbers: | MT-DMG-1 |
| Study First Received: | February 16, 2012 |
| Last Updated: | February 21, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Momelan Technologies:
|
Mohs surgery Excisional skin surgery Micrografting |
Additional relevant MeSH terms:
|
Neoplasms Skin Neoplasms Neoplasms by Site Skin Diseases |
ClinicalTrials.gov processed this record on May 23, 2013