Trial Outcomes & Findings for Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery (NCT NCT01442844)

NCT ID: NCT01442844

Last Updated: 2014-07-17

Results Overview

Recruitment status

TERMINATED

Study phase

Target enrollment

3 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-07-17

Participant Flow

Participant milestones

Participant milestones
Measure	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. 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 will be performed. Subject will receive dressings that are standard of care.
Overall Study STARTED	1	2
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Secondary Intention Wound Healing Versus Micrografting in Patients Undergoing Mohs Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Micrografting n=1 Participants 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 n=2 Participants No intervention will be performed. Subject will receive dressings that are standard of care.	Total n=3 Participants Total of all reporting groups
Age, Continuous	74 years n=5 Participants	66.5 years n=7 Participants	69 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	2 participants n=7 Participants	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Micrografting n=1 Participants 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 n=2 Participants No intervention will be performed. Subject will receive dressings that are standard of care.
Percentage of Wound Re-epithelialization	50 percentage of wound re-epithelialization	37.5 percentage of wound re-epithelialization Interval 25.0 to 50.0

Adverse Events

Micrografting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Alexandra Kimball

Massachusetts General Hospital

Phone: 617-726-5066

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place