CO2-laser Treatment for Caesarean Section Scars

Not Applicable

Completed

• Conditions: Cicatrix
• Interventions: Device: Fractional Co2-laser

• Registration Number: NCT02651298
• Lead Sponsor: Bispebjerg Hospital

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.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Status Verified: 2016-01
• Study First Submitted: 2016-01-02
• Study First Submitted QC: 2016-01-07
• Last Update Submitted: 2016-01-07
• Study First Posted: 2016-01-08
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractional CO2-laser	Fractional Co2-laser	3 treatments with fractional co2-laser

Primary Outcome Measures

Name	Time	Method
patient observer scar scale	up until 6 months post treatment	validated scar scale evaluations

Secondary Outcome Measures

Name	Time	Method
histology of scar tissue	3 months post treatment
erythema measured by reflectance	6 months post treatment	measured by reflectance
pigmentation measured by reflectance	6 months post treatment	measured by reflectance

Trial Locations

Locations (1)

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark