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CO2-laser Treatment for Caesarean Section Scars

Primary Purpose

Cicatrix

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Fractional Co2-laser
Sponsored by
Bispebjerg Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cicatrix

Eligibility Criteria

22 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Bispebjerg Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Fractional CO2-laser

Untreated control

Arm Description

3 treatments with fractional co2-laser

untreated control side of caesarean section scar

Outcomes

Primary Outcome Measures

patient observer scar scale
validated scar scale evaluations

Secondary Outcome Measures

erythema measured by reflectance
measured by reflectance
pigmentation measured by reflectance
measured by reflectance
erythema measured by reflectance
measured by reflectance
pigmentation measured by reflectance
measured by reflectance
erythema measured by reflectance
measured by reflectance
pigmentation measured by reflectance
measured by reflectance
histology of scar tissue

Full Information

First Posted
January 2, 2016
Last Updated
January 7, 2016
Sponsor
Bispebjerg Hospital
Collaborators
Lumenis Be Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT02651298
Brief Title
CO2-laser Treatment for Caesarean Section Scars
Official Title
Fractional CO2-laser Treatment of Caesarean Section Scars - A Randomized Controlled Split-scar Trial With Long Term Follow-up Assessment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bispebjerg Hospital
Collaborators
Lumenis Be Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cicatrix

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fractional CO2-laser
Arm Type
Experimental
Arm Description
3 treatments with fractional co2-laser
Arm Title
Untreated control
Arm Type
No Intervention
Arm Description
untreated control side of caesarean section scar
Intervention Type
Device
Intervention Name(s)
Fractional Co2-laser
Other Intervention Name(s)
Ablative fractional laser
Intervention Description
laser treatment
Primary Outcome Measure Information:
Title
patient observer scar scale
Description
validated scar scale evaluations
Time Frame
up until 6 months post treatment
Secondary Outcome Measure Information:
Title
erythema measured by reflectance
Description
measured by reflectance
Time Frame
1 months post treatment
Title
pigmentation measured by reflectance
Description
measured by reflectance
Time Frame
1 months post treatment
Title
erythema measured by reflectance
Description
measured by reflectance
Time Frame
3 months post treatment
Title
pigmentation measured by reflectance
Description
measured by reflectance
Time Frame
3 months post treatment
Title
erythema measured by reflectance
Description
measured by reflectance
Time Frame
6 months post treatment
Title
pigmentation measured by reflectance
Description
measured by reflectance
Time Frame
6 months post treatment
Title
histology of scar tissue
Time Frame
3 months post treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Haedersdal, Professor
Organizational Affiliation
Bispebjerg Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bispebjerg Hospital
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

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CO2-laser Treatment for Caesarean Section Scars

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