CO2-laser Treatment for Caesarean Section Scars

Cicatrix Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02651298
• Other study ID #: C-section
• Status: Completed
• Phase: N/A
• First received: January 2, 2016
• Last updated: January 7, 2016
• Start date: January 2014
• Est. completion date: January 2015

Study information

• Verified date: January 2016
• Source: Bispebjerg Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 22 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cicatrix

Intervention

Device:
• Fractional Co2-laser
laser treatment

Locations

Country	Name	City	State
Denmark	Bispebjerg Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Bispebjerg Hospital	Lumenis Ltd.

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient observer scar scale	validated scar scale evaluations	up until 6 months post treatment	No
Secondary	erythema measured by reflectance	measured by reflectance	1 months post treatment	No
Secondary	pigmentation measured by reflectance	measured by reflectance	1 months post treatment	No
Secondary	erythema measured by reflectance	measured by reflectance	3 months post treatment	No
Secondary	pigmentation measured by reflectance	measured by reflectance	3 months post treatment	No
Secondary	erythema measured by reflectance	measured by reflectance	6 months post treatment	No
Secondary	pigmentation measured by reflectance	measured by reflectance	6 months post treatment	No
Secondary	histology of scar tissue		3 months post treatment	No