Cicatrix
Conditions
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
DEVICEFractional Co2-laser
laser treatment
Sponsors
Lumenis Be Ltd.
Bispebjerg Hospital
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
| Measure | Time frame | Description |
|---|---|---|
| patient observer scar scale | up until 6 months post treatment | validated scar scale evaluations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| erythema measured by reflectance | 1 months post treatment | measured by reflectance |
| pigmentation measured by reflectance | 1 months post treatment | measured by reflectance |
| histology of scar tissue | 3 months post treatment | — |
Countries
Denmark
Outcome results
None listed