Pulsed Dye Laser Treatment of Recent Surgical Scars

NCT ID: NCT01201525

Last Updated: 2011-08-10

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

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-08-31

Brief Summary

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Hypothesis: Improvement of recent surgical scars after treatment with 595nm Pulsed dye laser treatments.

Study design: Prospective single blinded within patient controlled randomised trial. Recent surgical scars of at least 5cm will be divided into 2 parts and randomized. 1 part will be treated with 4 595nm Pulsed dye laser treatments on a 4 weeks interval. The other part will serve as a within patient control. 1 and 6 months after the intervention both parts of the scar will be evaluated.

Detailed Description

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Conditions

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Surgical Scars

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Surgical scar - part 1

Surgical scar - part 1

Group Type EXPERIMENTAL

Pulsed dye laser treatment

Intervention Type PROCEDURE

Part 1 of the surgical scar will be treated with 4 595nm Pulsed dye laser treatments.

Surgical scar - part 2

Surgical scar - part 2

Group Type PLACEBO_COMPARATOR

Control

Intervention Type PROCEDURE

Part 2 of the surgical scar will serve as a within patient control.

Interventions

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Pulsed dye laser treatment

Part 1 of the surgical scar will be treated with 4 595nm Pulsed dye laser treatments.

Intervention Type PROCEDURE

Control

Part 2 of the surgical scar will serve as a within patient control.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with planned surgical intervention leaving a scar from at least 5 cm in an area prone to hypertrophic scarring : neck, shoulders, chest, mandibular angle and extremities
* Age at least 18 years old.
* Patient able and willing to give written informed consent

Exclusion Criteria

* Patients with planned surgical intervention on hands, feet and genital area
* Patients with a history of photodermatoses
* Patients with a history of keloids
* Patients with a history of adverse outcomes related to PDL
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Principal Investigators

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Evelien Verhaeghe, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Related Links

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http://www.uzgent.be

website of the University Hospital Ghent

Other Identifiers

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2009/218

Identifier Type: -

Identifier Source: org_study_id

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