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

• Sponsor: Massachusetts General Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT01442844
• Collaborator: Momelan Technologies (Industry)
• Enrollment: 3
• Location: 1
• Arms: 2
• Duration (Months): 20
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Impaired Wound Healing	Device: Micrografting	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery
• Study Start Date: Sep 1, 2011
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Device: 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.
No Intervention: No intervention No intervention will be performed. Subject will receive dressings that are standard of care.

Outcome Measures

Primary Outcome Measures

1. Percentage of Wound Re-epithelialization [4 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mgh Curtis	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

• Massachusetts General Hospital
• Momelan Technologies

Investigators

• Principal Investigator: Alexandra B Kimball, MD, MPH, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital
• ClinicalTrials.gov Identifier: NCT01442844
• Other Study ID Numbers: 2010p002614
• First Posted: Sep 29, 2011
• Last Update Posted: Jul 17, 2014
• Last Verified: Jun 1, 2014

• Keywords provided by Alexandra Kimball, Director, Clinical Unit for Research Trials in Skin, Massachusetts General Hospital: Mohs; Scalp
• Additional relevant MeSH terms: Wounds and Injuries

Study Results

Participant Flow

Arm/Group Title	Micrografting	No Intervention
Arm/Group 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. 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.	No intervention will be performed. Subject will receive dressings that are standard of care.
Period Title: Overall Study
STARTED	1	2
COMPLETED	1	2
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Micrografting	No Intervention	Total
Arm/Group 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. 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.	No intervention will be performed. Subject will receive dressings that are standard of care.	Total of all reporting groups
Overall Participants	1	2	3
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	74	66.5	69
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	1 50%	1 33.3%
>=65 years	1 100%	1 50%	2 66.7%
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	1 100%	2 100%	3 100%
Region of Enrollment (participants) [Number]
United States	1 100%	2 100%	3 100%

Outcome Measures

1. Primary Outcome

Title	Percentage of Wound Re-epithelialization
Time Frame	4 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Micrografting	No Intervention
Arm/Group 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. 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.	No intervention will be performed. Subject will receive dressings that are standard of care.
Measure Participants	1	2
Mean (Full Range) [percentage of wound re-epithelialization]	50	37.5

Adverse Events

Arm/Group Title	Micrografting		No Intervention
Arm/Group 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. 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.		No intervention will be performed. Subject will receive dressings that are standard of care.
All Cause Mortality
	Micrografting		No Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Micrografting		No Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Micrografting		No Intervention
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.