The Effects of Fractional Carbon Dioxide (CO2) Laser Treatment Prior to Wound Closure

September 13, 2009 updated by: Moy-Fincher Medical Group

The Effects of Fractional CO2 Resurfacing Prior to Complex Wound Closure

The purpose of this study is to determine if fractional carbon dioxide laser treatment of a fresh wound at the time of surgery, decreases scar formation. Scar revision is commonly done at 6-10 weeks following surgery. Therefore, it may be more beneficial, for both the patient and physician, to perform scar revision at the time of surgery.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Moy-Fincher Medical Group
        • Contact:
          • Phone Number: 310-794-7422
        • Principal Investigator:
          • David Ozog, MD
        • Sub-Investigator:
          • Edgar Fincher, MD
        • Sub-Investigator:
          • Ronald Moy, MD
        • Sub-Investigator:
          • Lisa Chipps, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing skin cancer surgery
  • Will have a straight-line incision
  • Fluent in English
  • Must reside in the Los Angeles vicinity for the duration of the study

Exclusion Criteria:

  • Non-English speakers
  • Pregnant or cognitively impaired subjects

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Half of each subject's wound will not be treated.
Experimental: Laser resurfacing
Half of each subject's wound will be treated with a fractional CO2 laser.
Device: Lumenis fractional carbon dioxide laser
intra-operative laser resurfacing at time of wound closure
Other Names:
  • Lumenis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evidence of scar improvement as assessed by blinded-observer and patient ratings.
Time Frame: At two and six weeks following the procedure
At two and six weeks following the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Moy-Fincher Medical Group

Investigators

  • Principal Investigator: David Ozog, MD, Moy-Fincher Medical Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2009

Primary Completion (Anticipated)

December 1, 2009

Study Completion (Anticipated)

December 1, 2009

Study Registration Dates

First Submitted

August 29, 2009

First Submitted That Met QC Criteria

August 31, 2009

First Posted (Estimate)

September 1, 2009

Study Record Updates

Last Update Posted (Estimate)

September 15, 2009

Last Update Submitted That Met QC Criteria

September 13, 2009

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MF-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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