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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2008-07-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Investigators

Study Groups

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1

Group Type NO_INTERVENTION

Scalpel for tissue scoring

Intervention Type 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

Intervention Type DEVICE

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

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes