Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

Conditions
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Impaired Wound Healing

Intervention / Treatment
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* Device: Micrografting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Micrografting<br>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<br>* 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.<br>|
| No Intervention: No intervention<br>No intervention will be performed. Subject will receive dressings that are standard of care. | |

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mohs, Scalp