Cesarian ScarNCT01654406
Fractional CO2 Laser in the Treatment for Cesarian Scar
A study testing Fractional CO2 laser and pulsed dye laser and Pulsed dye laser in people with Cesarian Scar, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
Fractional CO2 laser can improve the Cesarian scar Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarian Scar
- What is being tested?
- Fractional CO2 laser and pulsed dye laser and Pulsed dye laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female receiving Cesarean surgery for more than 1 month
Who cannot join
- Pregnancy
- Keloid
- Photosensitivity
- Wound
- Pacemaker
- Recent retinoid intake
Trial locations and contacts
1 site in 1 country.
About this study
Fractional CO2 laser can improve the Cesarian scar
- Conditions
- Cesarian Scar
- Being tested
- Fractional CO2 laser and pulsed dye laser, Pulsed dye laser
- Keywords
- Cesarian scar, Fractional CO2 laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Pulsed dye laserDevice
Pulsed dye laser: 5mm,1.5ms,8J,delay cooling device 30/30,one pass
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Pulsed dye laser (V-beam) Receives: Device: Pulsed dye laser |
| Experimental group | Experimental | Fractional CO2 laser(eCO2)and pulsed dye laser (V-beam) Receives: Device: Fractional CO2 laser and pulsed dye laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1st, 5th, 7th month
Secondary outcomes (1)
Quartile grading scale
We measured quartile grading scale at 5th and 7th months of study.
Measured: 5th, 7th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: because 1 patient's scar becomes more severe than before, and most patient have satificated outcome
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarian ScarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654406
- Sponsor's protocol ID
- TMU-JIRB 201203007
- Status last verified
- Jul 2012
- First submitted
- 24 Jul 2012
- Last updated
- 13 Jul 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fractional CO2 Laser in the Treatment for Cesarian Scar
- ClinicalTrials.gov ID
- NCT01654406
- Acronym / sponsor ID
- TMU-JIRB 201203007
- Conditions
- Cesarian Scar
- Keywords
- Cesarian scar, Fractional CO2 laser
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: because 1 patient's scar becomes more severe than before, and most patient have satificated outcome
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 31 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fractional CO2 laser can improve the Cesarian scar
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Device: Pulsed dye laserPulsed dye laser (V-beam) |
| Experimental group | Experimental | Device: Fractional CO2 laser and pulsed dye laserFractional CO2 laser(eCO2)and pulsed dye laser (V-beam) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Female receiving Cesarean surgery for more than 1 month
Key exclusion criteria (6 listed)
- Pregnancy
- Keloid
- Photosensitivity
- Wound
- Pacemaker
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fractional CO2 laser and pulsed dye laserFractional 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 | Device | Experimental group |
| Pulsed dye laserPulsed dye laser: 5mm,1.5ms,8J,delay cooling device 30/30,one pass | Device | Control |
Primary outcome
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
1 secondary outcome
Quartile grading scale
Time frame: 5th, 7th month
Results and safety
The study was stopped early (reason given: because 1 patient's scar becomes more severe than before, and most patient have satificated outcome). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2016.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fractional CO2 laser and pulsed dye laser and Pulsed dye laser in people with Cesarian Scar, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: because 1 patient's scar becomes more severe than before, and most patient have satificated outcome). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of Vancouver Scar Scale (VSS) (time frame: 1st, 5th, 7th month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2016.