NCT01654406

Brief Summary

Fractional CO2 laser can improve the Cesarian scar

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 31, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

July 13, 2016

Status Verified

July 1, 2012

Enrollment Period

6 months

First QC Date

July 24, 2012

Last Update Submit

July 12, 2016

Conditions

Cesarian Scar

Keywords

Cesarian scarFractional CO2 laser

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Quartile grading scale

    5th, 7th month

Study Arms (2)

Control

ACTIVE COMPARATOR

Pulsed dye laser (V-beam)

Device: Pulsed dye laser

Experimental group

EXPERIMENTAL

Fractional CO2 laser(eCO2)and pulsed dye laser (V-beam)

Device: Fractional CO2 laser and pulsed dye laser

Interventions

Fractional CO2 laser and pulsed dye laserDEVICE

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

Experimental group
Pulsed dye laserDEVICE

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

Control

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Female receiving Cesarean surgery for more than 1 month

You may not qualify if:

  • Pregnancy
  • Keloid
  • Photosensitivity
  • Wound
  • Pacemaker
  • Recent retinoid intake

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wan Fang Hospital

Taipei, Taiwan, 116, Taiwan

Location

MeSH Terms

Interventions

Lasers, Dye

Intervention Hierarchy (Ancestors)

LasersOptical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2012

First Posted

July 31, 2012

Study Start

July 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

July 13, 2016

Record last verified: 2012-07

Locations

TW(1)