CO2-laser Treatment for Caesarean Section Scars

NCT ID: NCT02651298

Last Updated: 2016-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-01-31

Brief Summary

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

Detailed Description

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

Conditions

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Cicatrix

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fractional CO2-laser

3 treatments with fractional co2-laser

Group Type EXPERIMENTAL

Fractional Co2-laser

Intervention Type DEVICE

laser treatment

Untreated control

untreated control side of caesarean section scar

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Fractional Co2-laser

laser treatment

Intervention Type DEVICE

Other Intervention Names

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Ablative fractional laser

Eligibility Criteria

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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
Minimum Eligible Age

22 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Lumenis Be Ltd.

INDUSTRY

Sponsor Role collaborator

Bispebjerg Hospital

OTHER

Sponsor Role lead

Responsible Party

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Katrine Elisabeth Karmisholt

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Merete Haedersdal, Professor

Role: PRINCIPAL_INVESTIGATOR

Bispebjerg Hospital

Locations

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Bispebjerg Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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C-section

Identifier Type: -

Identifier Source: org_study_id

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