Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

Massachusetts General Hospital3 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Impaired Wound Healing

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes