Pulsed Dye Laser Treatment of Recent Surgical Scars

Pulsed Dye Laser Treatment of Recent Surgical Scars: A Prospective Single Blinded Within Patient Controlled Randomized Trial

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.

Study Overview

• Status: Completed
• Conditions: Surgical Scars
• Intervention / Treatment: Procedure: Pulsed dye laser treatment; Procedure: Control

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • University Hospital Ghent

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surgical scar - part 1	Procedure: Pulsed dye laser treatment; Part 1 of the surgical scar will be treated with 4 595nm Pulsed dye laser treatments.
Placebo Comparator: Surgical scar - part 2	Procedure: Control; Part 2 of the surgical scar will serve as a within patient control.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physician global assessment for the treated and control region (PhGA)	Before start of the study, 1 and 6 months after treatment
Patient global assessment for the treated and control region (PGA)	Before start of the study, 1 and 6 months after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
Assessment of scar color by colorimetry	Before start of the study, 1 and 6 months after treatment.
Assessment of scar tickness by ultrasound measurements	Before start of the study, 1 and 6 months after treatment.
Assessment of viscoelasticity by Cutometer measurements	Before start of the study, 1 and 6 months after treatment.
Clinical scar assessment by the Vancouver Scar scale and POSAS scale.	Before the start of the PDL treatment, and 1 and 6 months after the last treatment.

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Investigators: Principal Investigator: Evelien Verhaeghe, MD, University Hospital, Ghent

Publications and helpful links

Helpful Links

• Website of the University Hospital Ghent

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: December 2, 2009
• First Submitted That Met QC Criteria: September 13, 2010
• First Posted (Estimate): September 14, 2010

Study Record Updates

• Last Update Posted (Estimate): August 10, 2011
• Last Update Submitted That Met QC Criteria: August 9, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 2009/218