Use of the Epidermal Micrografts for Wound Healing After Mohs or Excisional Surgery for Skin Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-07-31

Brief Summary

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This case series will assess the use of suction blister epidermal grafts harvested by a novel device on select patients that have wounds from Mohs or excisional surgery.

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Detailed Description

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This study evaluates a novel micrografting technique to determine how it will influence the healing and cosmetic result of selected post surgical wounds in 12 subjects. The Epidermal Expansion System (designed by MoMelan Technologies) will generate an array of small microblisters and transfer the micrografts to a sterile wound dressing for application to the subject's surgical area. The sponsor hypothesizes that applying expanded micrografts to wounds that otherwise would have healed by second intention alone will hasten healing and possibly reduce scarring.

Conditions

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Neoplasm of Skin

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Micrografting

Group Type EXPERIMENTAL

Momelan Technologies Epidermal Graft Harvesting System

Intervention Type DEVICE

The procurement of the epidermal micrograft involves the use of the MoMelan Technologies suction blister system which consists of a control box that creates the vacuum necessary to create the microblisters and a harvester. The device is applied to the subject's thigh to create blisters. The epidermal micrografts are then harvested and transferred to Tegaderm™ and then placed on the surgical wound and the wound is bandaged.

Interventions

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Momelan Technologies Epidermal Graft Harvesting System

The procurement of the epidermal micrograft involves the use of the MoMelan Technologies suction blister system which consists of a control box that creates the vacuum necessary to create the microblisters and a harvester. The device is applied to the subject's thigh to create blisters. The epidermal micrografts are then harvested and transferred to Tegaderm™ and then placed on the surgical wound and the wound is bandaged.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Adult males and females between 35 and 90 years of age
* Status post skin cancer removal on the scalp, ear or leg with a wound that would otherwise be allowed to heal by secondary intention or grafting
* Wound considered appropriate by physician to receive epidermal grafting
* Willingness to participate in study by evidence of informed consent

Exclusion Criteria

* Female patients reported to be breastfeeding, pregnant or planning to become pregnant
* Clinical signs of infection
* Subjects currently on immunosuppressive medications, chemotherapy or a cytotoxic agent
* Participation in another interventional study with potential exposure to an investigational drug or device within the past 30 days or planned study entry within 90 days after study entrance.

Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No