CO2-laser Treatment for Caesarean Section Scars

January 7, 2016 updated by: Katrine Elisabeth Karmisholt, Bispebjerg Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Bispebjerg Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fractional CO2-laser
3 treatments with fractional co2-laser
Device: Fractional Co2-laser
laser treatment
Other Names:
  • Ablative fractional laser
No Intervention: Untreated control
untreated control side of caesarean section scar

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
patient observer scar scale
Time Frame: up until 6 months post treatment
validated scar scale evaluations
up until 6 months post treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
erythema measured by reflectance
Time Frame: 1 months post treatment
measured by reflectance
1 months post treatment
pigmentation measured by reflectance
Time Frame: 1 months post treatment
measured by reflectance
1 months post treatment
erythema measured by reflectance
Time Frame: 3 months post treatment
measured by reflectance
3 months post treatment
pigmentation measured by reflectance
Time Frame: 3 months post treatment
measured by reflectance
3 months post treatment
erythema measured by reflectance
Time Frame: 6 months post treatment
measured by reflectance
6 months post treatment
pigmentation measured by reflectance
Time Frame: 6 months post treatment
measured by reflectance
6 months post treatment
histology of scar tissue
Time Frame: 3 months post treatment
3 months post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bispebjerg Hospital

Collaborators

Lumenis Be Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

January 1, 2015

Study Registration Dates

First Submitted

January 2, 2016

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C-section

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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