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OpenTrials
Completed

NCT Number: NCT00367042

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

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.

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Key information

Conditions

Skin Cancer Neoplasms Neoplasms by Site Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

UC Davis Medical Center Department of Dermatology

Sacramento, California, 95816, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scalpel for tissue scoring

Device

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.

Surgical marker for tissue marking

Device

You will be asked to participate, examined, discuss participation have procedure and come in for follow up for photos and check up.

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Prospective Study To Determine Whether Tissue Scoring Results In Noticeable Marks Following Mohs Micrographic Surgery

Important dates

Study start
2005
Primary completion
2006
Study completion
2008
First posted
Aug 22, 2006
Registry last updated
Apr 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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