Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

NCT01442844 | Terminated Results

• 1 other identifier: 2010p002614
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Wound Healing

Keywords

Mohs; Scalp

Outcome Measures

Primary Outcomes (1)

• Percentage of Wound Re-epithelialization

  4 weeks

Study Arms (2)

Micrografting

ACTIVE COMPARATOR

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

No intervention

NO INTERVENTION

No intervention will be performed. Subject will receive dressings that are standard of care.

Interventions

Micrografting DEVICE

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.

Micrografting

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Female patients who are breastfeeding, pregnant, or planning to become pregnant
• Abnormal bleeding observed during initial Mohs procedure that would suggest a higher risk of post-operative bleeding
• Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Momelan Technologies: collaborator

Study Sites (1)

Mgh Curtis

Boston, Massachusetts, 02114, United States

Location

Results Point of Contact

• Title: Dr. Alexandra Kimball
• Organization: Massachusetts General Hospital

harvardskinstudies@partners.org

617-726-5066

Study Officials

• Alexandra B Kimball, MD, MPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Clinical Unit for Research Trials in Skin

Study Record Dates

• First Submitted: September 27, 2011
• First Posted: September 29, 2011
• Study Start: September 1, 2011
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: July 17, 2014
• Results First Posted: July 17, 2014

Record last verified: 2014-06

Locations

US (1)