NCT00367042

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
98

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2005

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 22, 2006

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

1 year

First QC Date

August 19, 2006

Last Update Submit

April 15, 2015

Conditions

Skin Cancer

Outcome Measures

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

    2 Years

Study Arms (1)

1

NO INTERVENTION
Device: Scalpel for tissue scoringDevice: Surgical marker for tissue marking

Interventions

Scalpel for tissue scoringDEVICE

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.

1
Surgical marker for tissue markingDEVICE

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

1

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Links

MeSH Terms

Conditions

Skin Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Daniel Eisen, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

  • Thomas King, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2006

First Posted

August 22, 2006

Study Start

July 1, 2005

Primary Completion

July 1, 2006

Study Completion

July 1, 2008

Last Updated

April 16, 2015

Record last verified: 2015-04

Locations

US(1)