Pulsed Dye Laser Treatment of Recent Surgical Scars

Not Applicable

Completed

• Conditions: Surgical Scars
• Interventions: Procedure: Pulsed dye laser treatment; Procedure: Control

• Registration Number: NCT01201525
• Lead Sponsor: University Hospital, Ghent

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2010-09-13
• Study First Posted: 2010-09-14
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-09
• Last Update Posted: 2011-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surgical scar - part 1	Pulsed dye laser treatment	Surgical scar - part 1
Surgical scar - part 2	Control	Surgical scar - part 2

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium