Laser Therapy for Pediatric Burn Scars

Study Overview
=================
Brief Summary
-----------------
A new era of outcomes for pediatric burn patients has begun as burn care continues to improve. Unfortunately, complete restoration of burn-injured skin may be limited by the development of hypertrophic scarring. Treatment with laser therapy is one of the newest forms of scar therapy available. Although laser therapy has only been adopted by burn clinicians within the last several years, early evidence suggests that it may offer significant benefits. Thus the aim of this study is to investigate the effectiveness of using laser therapy to treat hypertrophic burn scars in pediatric patients by using a comprehensive set of subjective and objective scar assessment tools.

Official Title
-----------------
A Controlled Trial Investigating the Use of Laser Therapy to Improve Pediatric Burn Scars.

Conditions
-----------------
Cicatrix, Hypertrophic, Burns

Intervention / Treatment
-----------------
* Device: Laser Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1-18 years at presentation Patients with a hypertrophic burn scar that has been clinically diagnosed by a burn care specialist Hypertrophic burn scar resulting from any etiology Hypertrophic burn scar is ≥ 2 months post healing Ability to complete English- language questionnaires Exclusion Criteria: Patients with concomitant skin disease (i.e. chronic skin conditions, herpes infection) Patients with a history of keloid scarring Patients who cannot tolerate the intravenous (IV) sedation used to perform laser therapy procedures Patients who have had previous laser therapy procedures

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Laser Therapy<br>Participants will receive laser therapy for the treatment of their hypertrophic burn scars. Laser treatment decisions will be tailored to meet the needs of the patient. | Device: Laser Therapy<br>* Laser therapy is a technology that can be used to treat hypertrophic burn scars.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancouver Scar Scale Score | The Vancouver Scar Scale is composed of four subscales which include pigmentation (range: 0 - 3), vascularity (range: 0 - 3), pliability (range: 0 - 5), and height (range: 0 - 3). Total Vancouver Scar Scale score refers to the score obtained by summing the values from each subscale (range: 0 - 14) with higher scores indicating a worse scar. | Baseline (month 0) to month 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient and Observer Scar Assessment Scale Score | The Patient and Observer Scar Assessment Scale consists of two independent scales: 1) the patient scale (patient-reported), and 2) the observer scale (clinician-reported). Both the patient scale as well as the observer scale include a set of individual subscales that assess scar severity (range: 1 - 10) with higher scores indicating a worse scar. | Baseline (month 0) to month 12 | 
| Scar thickness | Scar thickness measurements will be taken at five study visits over the course of one year and will be measured using ultrasonography. | Baseline(month 0) to month 12 | 
| Scar stiffness measured by the DermaLab Combo® skin analysis device | Scar stiffness measurements will be taken at five study visits over the course of one year and will be measured using the DermaLab Combo® skin analysis device (Cortex Technologies, Hadsund, DK). | Baseline(month 0) to month 12 | 
| Scar stiffness measured by ultrasound elastographgy | Scar stiffness measurements will be taken at five study visits over the course of one year and will be measured using ultrasound elastography. | Baseline(month 0) to month 12 | 
| Scar colour | Scar colour measurements will be taken at five study visits over the course of one year and will be measured using the DermaLab Combo® skin analysis device (Cortex Technologies, Hadsund, DK) | Baseline(month 0) to month 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pediatric, Laser, Burn, Scar, Photothermolysis