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Fractional CO2 Laser in the Treatment for Cesarian Scar

This study has been terminated.
(because 1 patient's scar becomes more severe than before, and most patient have satificated outcome)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01654406
First Posted: July 31, 2012
Last Update Posted: July 13, 2016
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.
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital
  Purpose
Fractional CO2 laser can improve the Cesarian scar

Condition Intervention
Cesarian Scar Device: Fractional CO2 laser and pulsed dye laser Device: Pulsed dye laser

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

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


Enrollment: 8
Study Start Date: July 2012
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
  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): NCT01654406


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

Responsible Party: Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01654406     History of Changes
Other Study ID Numbers: TMU-JIRB 201203007
First Submitted: July 24, 2012
First Posted: July 31, 2012
Last Update Posted: July 13, 2016
Last Verified: July 2012

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