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NCT01654406 Clinical Trial

Fractional CO2 Laser in the Treatment for Cesarian Scar

Cesarian Scar Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01654406
Other study ID # TMU-JIRB 201203007
Secondary ID
Status Terminated
Phase N/A
First received July 24, 2012
Last updated July 12, 2016
Start date July 2012
Est. completion date January 2013

Study information
Verified date July 2012
Source Taipei Medical University WanFang Hospital
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Fractional CO2 laser can improve the Cesarian scar

Recruitment information / eligibility
Status Terminated
Enrollment 8
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

- Female receiving Cesarean surgery for more than 1 month

Exclusion Criteria:

- Pregnancy

- Keloid

- Photosensitivity

- Wound

- Pacemaker

- Recent retinoid intake

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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
• Pulsed dye laser
Pulsed dye laser: 5mm,1.5ms,8J,delay cooling device 30/30,one pass

Locations
Country Name City State
Taiwan Wan Fang Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary change of Vancouver Scar Scale (VSS) We measured quartile grading scale at 1st, 5th and 7th months of study and evaluated the change of the scale 1st, 5th, 7th month No
Secondary Quartile grading scale We measured quartile grading scale at 5th and 7th months of study. 5th, 7th month No