Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

Study Results

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-05-31

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.

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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.

Conditions

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Impaired Wound Healing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Micrografting

Intervention Type 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.

No intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No