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

This study has been terminated.
(The study sponsor was acquired by a company that focuses on chronic wounds)
Sponsor:
Collaborator:
Momelan Technologies
Information provided by (Responsible Party):
Alexandra Kimball, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01442844
First received: September 27, 2011
Last updated: June 18, 2014
Last verified: June 2014
  Purpose

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 Intervention
Impaired Wound Healing
Device: Micrografting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Percentage of Wound Re-epithelialization [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 3
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: September 27, 2011
Results First Received: June 18, 2014
Last Updated: June 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Mohs
Scalp

ClinicalTrials.gov processed this record on July 29, 2014