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

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.

Study Overview

• Status: Terminated
• Conditions: Impaired Wound Healing
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Mgh Curtis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of Wound Re-epithelialization	4 weeks

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Momelan Technologies
• Investigators: Principal Investigator: Alexandra B Kimball, MD, MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): May 1, 2013

Study Registration Dates

• First Submitted: September 27, 2011
• First Submitted That Met QC Criteria: September 28, 2011
• First Posted (Estimate): September 29, 2011

Study Record Updates

• Last Update Posted (Estimate): July 17, 2014
• Last Update Submitted That Met QC Criteria: June 18, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: Scalp; Mohs
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: 2010p002614