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CO2-laser Treatment for Caesarean Section Scars

Fractional CO2-laser Treatment of Caesarean Section Scars - A Randomized Controlled Split-scar Trial With Long Term Follow-up Assessment

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02651298
Enrollment
12
Registered
2016-01-08
Start date
2014-01-31
Completion date
2015-01-31
Last updated
2016-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cicatrix

Brief summary

Fractional Co2-laser for treatment of mature caesarean section scars.

Detailed description

Randomized split scar study to document improvement of caesarean section scars as compared to untreated control scar.

Interventions

laser treatment

Sponsors

Lumenis Be Ltd.
CollaboratorINDUSTRY
Bispebjerg Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
22 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* mature caesarean section scar

Exclusion criteria

* systemic uncontrolled disease * recent or current cancer * smoking * keloid formation * wounds or local disease int treatment area * pregnancy or lactation

Design outcomes

Primary

MeasureTime frameDescription
patient observer scar scaleup until 6 months post treatmentvalidated scar scale evaluations

Secondary

MeasureTime frameDescription
erythema measured by reflectance1 months post treatmentmeasured by reflectance
pigmentation measured by reflectance1 months post treatmentmeasured by reflectance
histology of scar tissue3 months post treatment

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026