Clinical Trial: CO2-laser Treatment for Caesarean Section Scars

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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

Detailed Summary: Randomized split scar study to document improvement of caesarean section scars as compared to untreated control scar.
Sponsor: Bispebjerg Hospital

Current Primary Outcome: patient observer scar scale [ Time Frame: up until 6 months post treatment ]

validated scar scale evaluations


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • erythema measured by reflectance [ Time Frame: 1 months post treatment ]
    measured by reflectance
  • pigmentation measured by reflectance [ Time Frame: 1 months post treatment ]
    measured by reflectance
  • erythema measured by reflectance [ Time Frame: 3 months post treatment ]
    measured by reflectance
  • pigmentation measured by reflectance [ Time Frame: 3 months post treatment ]
    measured by reflectance
  • erythema measured by reflectance [ Time Frame: 6 months post treatment ]
    measured by reflectance
  • pigmentation measured by reflectance [ Time Frame: 6 months post treatment ]
    measured by reflectance
  • histology of scar tissue [ Time Frame: 3 months post treatment ]


Original Secondary Outcome: Same as current

Information By: Bispebjerg Hospital

Dates:
Date Received: January 2, 2016
Date Started: January 2014
Date Completion:
Last Updated: January 7, 2016
Last Verified: January 2016