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

Mass General Brigham

Status: Terminated

Conditions: Impaired Wound Healing

Treatments: Device: Micrografting

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01442844

2010p002614

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups

Micrografting

Active Comparator group

Description:

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.

Treatment:

Device: Micrografting

No intervention

No Intervention group

Description:

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