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

This study has been completed.
Sponsor:
Information provided by:
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00367042
First received: August 19, 2006
Last updated: June 3, 2011
Last verified: June 2011
  Purpose

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.


Condition Intervention Phase
Skin Cancer
Device: Scalpel for tissue scoring
Device: Surgical marker for tissue marking
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Official Title: Prospective Study To Determine Whether Tissue Scoring Results In Noticeable Marks Following Mohs Micrographic Surgery

Further study details as provided by University of California, Davis:

Primary Outcome Measures:
  • 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 [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Enrollment: 98
Study Start Date: July 2005
Study Completion Date: July 2008
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1 Device: Scalpel for tissue scoring
During Mohs surgery we will compare the outcomes of scarring, to determine whether a mark (with a pen) or a score with a scalpel will receive the best scar.
Device: Surgical marker for tissue marking
You will be asked to participate, examined, discuss participation have procedure and come in for follow up for photos and check up.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00367042

Locations
United States, California
UC Davis Medical Center Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Daniel Eisen, MD University of California, Davis
Principal Investigator: Thomas King, MD University of California, Davis
  More Information

No publications provided

Responsible Party: Daniel Eisen, MD, University of California Davis
ClinicalTrials.gov Identifier: NCT00367042     History of Changes
Other Study ID Numbers: 200513516-1
Study First Received: August 19, 2006
Last Updated: June 3, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 21, 2014