Fractional CO2 Laser in the Treatment for Cesarian Scar

This study is currently recruiting participants.
Verified July 2012 by Taipei Medical University WanFang Hospital
Sponsor:
Information provided by (Responsible Party):
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01654406
First received: July 24, 2012
Last updated: July 27, 2012
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.


Estimated Enrollment: 20
Study Start Date: July 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female receiving Cesarian surgery for more than 1 month

Exclusion Criteria:

  • Pregnancy
  • Keloid
  • Photosenssitivity
  • Wound
  • Pacemaker
  • Recent retinoid intake
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01654406

Contacts
Contact: Yu-Chen Huang, MD 886-968965969 dhist2002@yahoo.com.tw

Locations
Taiwan
Wan Fang Hospital Recruiting
Taipei, Taiwan, 116
Contact: Yu-Chen Huang, MD       dhist2002@yahoo.com.tw   
Principal Investigator: Ying-Yi Chiang, MD         
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
  More Information

No publications provided

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 27, 2012
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014