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OpenTrials
Completed

NCT Number: NCT02651298

CO2-laser Treatment for Caesarean Section Scars

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

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Key information

Age range

22 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Bispebjerg Hospital

Copenhagen, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fractional Co2-laser

Device

laser treatment

Other names: Ablative fractional laser

Primary outcomes

  1. patient observer scar scale

    Time frame: up until 6 months post treatment

    validated scar scale evaluations

Secondary outcomes

  1. erythema measured by reflectance

    Time frame: 1 months post treatment

    measured by reflectance

  2. pigmentation measured by reflectance

    Time frame: 1 months post treatment

    measured by reflectance

  3. erythema measured by reflectance

    Time frame: 3 months post treatment

    measured by reflectance

  4. pigmentation measured by reflectance

    Time frame: 3 months post treatment

    measured by reflectance

  5. erythema measured by reflectance

    Time frame: 6 months post treatment

    measured by reflectance

  6. pigmentation measured by reflectance

    Time frame: 6 months post treatment

    measured by reflectance

  7. histology of scar tissue

    Time frame: 3 months post treatment

Sponsors and collaborators

Lead sponsor

Bispebjerg Hospital

Other

Collaborators

  • Lumenis Be Ltd.

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jan 8, 2016
Registry last updated
Jan 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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