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

Primary Purpose

Neoplasm of Skin

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Momelan Technologies Epidermal Graft Harvesting System

About this trial

This is an interventional treatment trial for Neoplasm of Skin focused on measuring Mohs surgery, Excisional skin surgery, Micrografting

Eligibility Criteria

35 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

DuPage Medical GroupRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Micrografting

Arm Description

Outcomes

Primary Outcome Measures

Wound healing/scarring

Secondary Outcome Measures

Incidence of adverse events

Physician global satisfaction

Subject global satisfaction

Full Information

NCT ID

NCT01536444

First Posted

February 16, 2012

Last Updated

February 21, 2012

Sponsor

Momelan Technologies

1. Study Identification

Unique Protocol Identification Number

NCT01536444

Brief Title

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

Official Title

Use of the Epidermal Expansion System to Harvest and Place Suction Blister Epidermal Grafts on Wounds in Patients After Mohs or Excisional Surgery for Skin Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Unknown status

Study Start Date

January 2012 (undefined)

Primary Completion Date

July 2012 (Anticipated)

Study Completion Date

July 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Momelan Technologies

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neoplasm of Skin

Keywords

Mohs surgery, Excisional skin surgery, Micrografting

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Micrografting

Arm Type

Experimental

Intervention Type

Device

Intervention Name(s)

Momelan Technologies Epidermal Graft Harvesting System

Intervention Description

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.

Primary Outcome Measure Information:

Title

Wound healing/scarring

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Incidence of adverse events

Time Frame

6 weeks

Title

Physician global satisfaction

Time Frame

6 weeks

Title

Subject global satisfaction

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert LaRoche

Phone

978-376-2879

robert.laroche@momelan.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashish C. Bhatia, MD

Organizational Affiliation

DuPage Medical Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

DuPage Medical Group

City

Naperville

State/Province

Illinois

ZIP/Postal Code

60563

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ashish C. Bhatia, MD

Phone

630-547-5040

Ashish.Bhatia@Dupagemd.com

First Name & Middle Initial & Last Name & Degree

Peri Todd

Phone

630-942-7956

Peri.Todd@Dupagemd.com

First Name & Middle Initial & Last Name & Degree

Ashish C. Bhatia, MD

12. IPD Sharing Statement

Learn more about this trial

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

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