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Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery (MomelanMohs)

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ClinicalTrials.gov Identifier: NCT01442844
Recruitment Status : Terminated (The study sponsor was acquired by a company that focuses on chronic wounds)
First Posted : September 29, 2011
Results First Posted : July 17, 2014
Last Update Posted : July 17, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study evaluates a novel micrografting technique to see how it will influence the healing rate and cosmetic result of second intention wounds. The graft harvesting and micrografting process was designed by MoMelan Technologies The Epidermal Expansion System, which is composed of a commercially available Blister Generation Device and the Microblister Generation and Excision Device (MBGED), will generate an array of small microblisters and transfer the micrografts to a sterile dressing (Tegaderm™ - an FDA approved wound dressing) for application to the subject's surgical area. The investigators predict that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possible reduce scarring.

Condition or disease Intervention/treatment
Impaired Wound Healing Device: Micrografting

Detailed Description:
Participants with a scalp wound s/p Mohs procedure will be randomized to a micrografting technique intervention or to no intervention/heal with secondary intention alone (control). Intervention consists of harvesting skin micrografts (1.75mm) from pigmented skin using the Microblister generation and excision device and transfer the micrografts to a sterile dressing for application to the participants scalp wound. Percent wound re-epithelialization will be compared between two groups.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery
Study Start Date : September 2011
Primary Completion Date : May 2013
Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Micrografting
Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.
Device: Micrografting
Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.
No Intervention: No intervention
No intervention will be performed. Subject will receive dressings that are standard of care.


Outcome Measures

Primary Outcome Measures :
  1. Percentage of Wound Re-epithelialization [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Between 40-75 years old
  2. Status post Mohs procedure on the scalp with a wound that would otherwise be allowed to heal by second intention
  3. Superficial would-at deepest of 2.0 mm or to superficial fat, but not deep to muscle
  4. Area is less then 6 cm2 (wound diameter less than 2cm)

Exclusion Criteria:

  1. Female patients who are breastfeeding, pregnant, or planning to become pregnant
  2. Abnormal bleeding observed during initial Mohs procedure that would suggest a higher risk of post-operative bleeding
  3. Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
  4. Participation in another interventional study with potential exposure to an investigational drug within past 30 days or planned study entry within 90 days after study entrance
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01442844


Locations
United States, Massachusetts
Mgh Curtis
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Momelan Technologies
Investigators
Principal Investigator: Alexandra B Kimball, MD, MPH Massachusetts General Hospital
More Information

Responsible Party: Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01442844     History of Changes
Other Study ID Numbers: 2010p002614
First Posted: September 29, 2011    Key Record Dates
Results First Posted: July 17, 2014
Last Update Posted: July 17, 2014
Last Verified: June 2014

Keywords provided by Alexandra Kimball, Massachusetts General Hospital:
Mohs
Scalp

Additional relevant MeSH terms:
Wounds and Injuries