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

Phase 2

Completed

• Conditions: Skin Cancer
• Interventions: Device: Scalpel for tissue scoring; Device: Surgical marker for tissue marking

• Registration Number: NCT00367042
• Lead Sponsor: University of California, Davis

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2005-07
• Primary Completion: 2006-07
• Study First Submitted: 2006-08-19
• Study First Submitted QC: 2006-08-19
• Study First Posted: 2006-08-22
• Study Completion: 2008-07
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Scalpel for tissue scoring	-
1	Surgical marker for tissue marking	-

Primary Outcome Measures

Name	Time	Method
The goal of the study is to determine if there are any noticeable differences in outcomes between patients who have their skin scored and those who have their skin marked with a surgical marking pen	2 Years

Trial Locations

Locations (1)

UC Davis Medical Center Department of Dermatology; 🇺🇸 Sacramento, California, United States