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:
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01654406
First received: July 24, 2012
Last updated: July 12, 2016
Last verified: July 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   Child, Adult, Senior
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: July 24, 2012
Last Updated: July 12, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 28, 2016