Study to Determine if Tissue Scored With a Scalpel Results in Any Noticeable Marks - Full Text View

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00367042

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 II Phase III

MedlinePlus related topics: Cancer Skin Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Investigator), Active Control, Single Group Assignment
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 ]

Estimated Enrollment:	100
Study Start Date:	July 2005
Estimated Study Completion Date:	July 2008

Arms	Assigned Interventions
1: No Intervention	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

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, M.D.	University of California, Davis
Principal Investigator:	Thomas King, M.D.	University of California, Davis

More Information

Responsible Party:	University of California Davis ( Daniel Eisen, MD )
Study ID Numbers:	200513516-1
Study First Received:	August 19, 2006
Last Updated:	June 12, 2008
ClinicalTrials.gov Identifier:	NCT00367042
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Skin Diseases
Skin Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009