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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00969475
Recruitment Status : Unknown
Verified September 2009 by Moy-Fincher Medical Group.
Recruitment status was:  Not yet recruiting
First Posted : September 1, 2009
Last Update Posted : September 15, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Scars Device: Lumenis fractional carbon dioxide laser

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Fractional CO2 Resurfacing Prior to Complex Wound Closure
Study Start Date : October 2009
Estimated Primary Completion Date : December 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Lumenis


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969475


Contacts
Contact: Telia DeBoyes tdeboyes@yahoo.com

Locations
United States, California
Moy-Fincher Medical Group Not yet recruiting
Los Angeles, California, United States, 90095
Contact    310-794-7422      
Principal Investigator: David Ozog, MD         
Sub-Investigator: Edgar Fincher, MD         
Sub-Investigator: Ronald Moy, MD         
Sub-Investigator: Lisa Chipps, MD         
Sponsors and Collaborators
Moy-Fincher Medical Group
Investigators
Principal Investigator: David Ozog, MD Moy-Fincher Medical Group
More Information

Responsible Party: Ronald Moy, MD, Moy-Fincher Medical Group
ClinicalTrials.gov Identifier: NCT00969475     History of Changes
Other Study ID Numbers: MF-01
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: September 15, 2009
Last Verified: September 2009

Keywords provided by Moy-Fincher Medical Group:
scar revision
intraoperative
fractional carbon dioxide laser