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Completed

NCT Number: NCT02707627

Laser Therapy for 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.

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Key information

Conditions

Cicatrix, Hypertrophic Burns Cicatrix Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laser Therapy

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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)

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2020
Study completion
2021
First posted
Mar 14, 2016
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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