Pulsed Dye Laser Treatment of Recent Surgical Scars

Study Overview
=================
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.

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

Conditions
-----------------
Surgical Scars

Intervention / Treatment
-----------------
* Procedure: Pulsed dye laser treatment
* Procedure: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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. |