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Study to Determine if Tissue Scored With a Scalpel Results in Any Noticeable Marks

University of California (UC) Davis logo

University of California (UC) Davis

Status and phase

Completed
Phase 3
Phase 2

Conditions

Skin Cancer

Treatments

Device: Scalpel for tissue scoring
Device: Surgical marker for tissue marking

Study type

Interventional

Funder types

Other

Identifiers

NCT00367042
200513516-1

Details and patient eligibility

About

Mohs Micrographic Surgery is a well established method for treatment of cutaneous malignancies. Part of this technique requires marking skin surrounding the tumor. There are two ways of marking the tissue, lightly scoring it with a scalpel or marking it with a surgical marker.

This study is to determine if there is a noticeable difference in outcome between patients who have their tissue lightly scored with a scalpel or marked with a surgical marking pen.

Full description

Mohs Micrographic Surgery is a well established method utilizing microscopic margin controlled excision for treatment of cutaneous malignancies (See Appendix A). It has the highest cure rate of any of the methods used to treat common cutaneous malignancies and is a proven safe outpatient procedure. Part of the technique requires marking skin surrounding the tumor to correspond with tissue that has been removed and divided into pieces for processing and microscopic examination. Currently there are two established ways of marking the tissue; lightly scoring it with a scalpel or marking it with a surgical marker. Scoring tissue is faster, more accurate, and there is no risk of having the marking washed or rubbed away.

Enrollment

98 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients who are able to legally consent to study and are scheduled for Mohs Micrographic Surgery to remove their malignancies

Exclusion criteria

  • Patients who are unable to legally consent themselves, do not wish to participate or who are not scheduled to undergo Mohs Micrographic Surgery.
  • Children, those with mental handicaps, pregnant women, prisoners, those with cognitive impairments, and life-threatening diseases will be excluded.

Trial design

98 participants in 1 patient group

1
No Intervention group
Treatment:
Device: Scalpel for tissue scoring
Device: Surgical marker for tissue marking

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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