- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01654406
Fractional CO2 Laser in the Treatment for Cesarian Scar
July 12, 2016 updated by: Taipei Medical University WanFang Hospital
Fractional CO2 laser can improve the Cesarian scar
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 116
- Wan Fang Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Female receiving Cesarean surgery for more than 1 month
Exclusion Criteria:
- Pregnancy
- Keloid
- Photosensitivity
- Wound
- Pacemaker
- Recent retinoid intake
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control
Pulsed dye laser (V-beam)
|
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)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
1st, 5th, 7th month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quartile grading scale
Time Frame: 5th, 7th month
|
We measured quartile grading scale at 5th and 7th months of study.
|
5th, 7th month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2012
Primary Completion (Actual)
January 1, 2013
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
July 24, 2012
First Submitted That Met QC Criteria
July 27, 2012
First Posted (Estimate)
July 31, 2012
Study Record Updates
Last Update Posted (Estimate)
July 13, 2016
Last Update Submitted That Met QC Criteria
July 12, 2016
Last Verified
July 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TMU-JIRB 201203007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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