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Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery (MomelanMohs)

Primary Purpose

Impaired Wound Healing

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Micrografting
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impaired Wound Healing focused on measuring Mohs, Scalp

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mgh Curtis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Micrografting

No intervention

Arm Description

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 will be performed. Subject will receive dressings that are standard of care.

Outcomes

Primary Outcome Measures

Percentage of Wound Re-epithelialization

Secondary Outcome Measures

Full Information

First Posted
September 27, 2011
Last Updated
June 18, 2014
Sponsor
Massachusetts General Hospital
Collaborators
Momelan Technologies
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1. Study Identification

Unique Protocol Identification Number
NCT01442844
Brief Title
Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery
Acronym
MomelanMohs
Official Title
Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Why Stopped
The study sponsor was acquired by a company that focuses on chronic wounds
Study Start Date
September 2011 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
Momelan Technologies

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impaired Wound Healing
Keywords
Mohs, Scalp

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micrografting
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention will be performed. Subject will receive dressings that are standard of care.
Intervention Type
Device
Intervention Name(s)
Micrografting
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Wound Re-epithelialization
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexandra B Kimball, MD, MPH
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mgh Curtis
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

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