Laser Therapy for Pediatric Burn Scars

August 16, 2021 updated by: Joel Fish, The Hospital for Sick Children

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Eligible participants will be pediatric patients with hypertrophic scars requiring treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vancouver Scar Scale Score
Time Frame: 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.
Baseline (month 0) to month 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient and Observer Scar Assessment Scale Score
Time Frame: 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.
Baseline (month 0) to month 12
Scar thickness
Time Frame: 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.
Baseline(month 0) to month 12
Scar stiffness measured by the DermaLab Combo® skin analysis device
Time Frame: 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).
Baseline(month 0) to month 12
Scar stiffness measured by ultrasound elastographgy
Time Frame: 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.
Baseline(month 0) to month 12
Scar colour
Time Frame: 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)
Baseline(month 0) to month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2016

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

January 1, 2021

Study Registration Dates

First Submitted

March 3, 2016

First Submitted That Met QC Criteria

March 8, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hospital for Sick Children

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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