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Fractional CO2 Laser in the Treatment for Cesarian Scar

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ClinicalTrials.gov Identifier: NCT01654406
Recruitment Status : Terminated (because 1 patient's scar becomes more severe than before, and most patient have satificated outcome)
First Posted : July 31, 2012
Last Update Posted : July 13, 2016
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital

Brief Summary:
Fractional CO2 laser can improve the Cesarian scar

Condition or disease Intervention/treatment Phase
Cesarian Scar Device: Fractional CO2 laser and pulsed dye laser Device: Pulsed dye laser Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2012
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Control
Pulsed dye laser (V-beam)
Device: Pulsed dye laser
Pulsed dye laser: 5mm,1.5ms,8J,delay cooling device 30/30,one pass
Experimental: Experimental group
Fractional CO2 laser(eCO2)and pulsed dye laser (V-beam)
Device: Fractional CO2 laser and pulsed dye laser
Fractional CO2 laser: 50 mJ, 100 spots/cm2, a scan area of 4_4mm, static mode, and two passes Pulsed dye laser: 5mm,1.5ms,8J,delay cooling device 30/30,one pass



Primary Outcome Measures :
  1. change of Vancouver Scar Scale (VSS) [ Time Frame: 1st, 5th, 7th month ]
    We measured quartile grading scale at 1st, 5th and 7th months of study and evaluated the change of the scale


Secondary Outcome Measures :
  1. Quartile grading scale [ Time Frame: 5th, 7th month ]
    We measured quartile grading scale at 5th and 7th months of study.



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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female receiving Cesarean surgery for more than 1 month

Exclusion Criteria:

  • Pregnancy
  • Keloid
  • Photosensitivity
  • Wound
  • Pacemaker
  • Recent retinoid intake

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): NCT01654406


Locations
Taiwan
Wan Fang Hospital
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital

Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01654406     History of Changes
Other Study ID Numbers: TMU-JIRB 201203007
First Posted: July 31, 2012    Key Record Dates
Last Update Posted: July 13, 2016
Last Verified: July 2012

Keywords provided by Taipei Medical University WanFang Hospital:
Cesarian scar
Fractional CO2 laser