Laser Therapy for Pediatric Burn Scars

Sponsor

The Hospital for Sick Children (Other)

Overall Status

Completed

CT.gov ID

NCT02707627

Collaborator

(none)

Enrollment

Location

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cicatrix, Hypertrophic Burns	Device: Laser Therapy

Study Design

Study Type:

Observational

Actual Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

May 1, 2020

Actual Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Laser Therapy 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 Laser therapy is a technology that can be used to treat hypertrophic burn scars.

Arm

Intervention/Treatment

Laser Therapy

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

Laser therapy is a technology that can be used to treat hypertrophic burn scars.

Outcome Measures

Primary Outcome Measures

Vancouver Scar Scale Score [Baseline (month 0) to month 12]
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.

Secondary Outcome Measures

Patient and Observer Scar Assessment Scale Score [Baseline (month 0) to month 12]
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.
Scar thickness [Baseline(month 0) to month 12]
Scar thickness measurements will be taken at five study visits over the course of one year and will be measured using ultrasonography.
Scar stiffness measured by the DermaLab Combo® skin analysis device [Baseline(month 0) to month 12]
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).
Scar stiffness measured by ultrasound elastographgy [Baseline(month 0) to month 12]
Scar stiffness measurements will be taken at five study visits over the course of one year and will be measured using ultrasound elastography.
Scar colour [Baseline(month 0) to month 12]
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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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