An observational study in Cicatrix, Hypertrophic and Burns, sponsored by The Hospital for Sick Children. Completed at 1 site in Canada. Open to participants aged 1 Year to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-08-17.
Sponsored by The Hospital for Sick Children · Observational
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.
307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.
This study's enrollment of 20 is below the median of 38 across 34 observational studies indexed under Cicatrix.
Browse Cicatrix studies →The Hospital for Sick Children is the lead sponsor of 568 studies on the registry; 81 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Eligible participants will be pediatric patients with hypertrophic scars requiring treatment.
Exclusion Criteria:
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.
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.
Time frame: Baseline (month 0) to month 12
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.
Time frame: Baseline (month 0) to month 12
Scar thickness
Scar thickness measurements will be taken at five study visits over the course of one year and will be measured using ultrasonography.
Time frame: Baseline(month 0) to month 12
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).
Time frame: Baseline(month 0) to month 12
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.
Time frame: Baseline(month 0) to month 12
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)
Time frame: Baseline(month 0) to month 12
This study is completed, as verified in Aug 2021. You cannot join it, but the record below documents what was studied.
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The Hospital for Sick Children