MedPath

Laser Therapy for Pediatric Burn Scars

Completed
Conditions
Burns
Cicatrix, Hypertrophic
Interventions
Device: Laser Therapy
Registration Number
NCT02707627
Lead Sponsor
The Hospital for Sick Children
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
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 & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Laser TherapyLaser TherapyParticipants 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.
Primary Outcome Measures
NameTimeMethod
Vancouver Scar Scale ScoreBaseline (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
NameTimeMethod
Patient and Observer Scar Assessment Scale ScoreBaseline (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 stiffness measured by ultrasound elastographgyBaseline(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 colourBaseline(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)

Scar thicknessBaseline(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 deviceBaseline(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).

Trial Locations

Locations (1)

Hospital for Sick Children

🇨🇦

Toronto, Ontario, Canada

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