Laser Therapy for Pediatric Burn Scars

Burns Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02707627
• Other study ID #: Hospital for Sick Children
• Status: Completed
• Start date: October 2016
• Est. completion date: January 2021

Study information

• Verified date: August 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2021
• Est. primary completion date: May 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

1. Age 1-18 years at presentation

2. Patients with a hypertrophic burn scar that has been clinically diagnosed by a burn care specialist

3. Hypertrophic burn scar resulting from any etiology

4. Hypertrophic burn scar is = 2 months post healing

5. Ability to complete English- language questionnaires

Exclusion Criteria:

1. Patients with concomitant skin disease (i.e. chronic skin conditions, herpes infection)

2. Patients with a history of keloid scarring

3. Patients who cannot tolerate the intravenous (IV) sedation used to perform laser therapy procedures

4. Patients who have had previous laser therapy procedures

Related Conditions & MeSH terms

• Burns
• Cicatrix
• Cicatrix, Hypertrophic

Intervention

Device:
• Laser Therapy
Laser therapy is a technology that can be used to treat hypertrophic burn scars.

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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