Laser Therapy for Pediatric Burn Scars

NCT02707627 | Completed DMC

• 1 other identifier: Hospital for Sick Children
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cicatrix, Hypertrophic; Burns

Keywords

Pediatric; Laser; Burn; Scar; Photothermolysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient and Observer Scar Assessment Scale Score

  Baseline (month 0) to month 12

• Scar thickness

  Baseline(month 0) to month 12

• Scar stiffness measured by the DermaLab Combo® skin analysis device

  Baseline(month 0) to month 12

• Scar stiffness measured by ultrasound elastographgy

  Baseline(month 0) to month 12

• Scar colour

  Baseline(month 0) to month 12

Study Arms (1)

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

Interventions

Laser Therapy DEVICE

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

Laser Therapy

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

MeSH Terms

Conditions

Cicatrix, Hypertrophic; Burns; Cicatrix

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Burn Program

Study Record Dates

• First Submitted: March 3, 2016
• First Posted: March 14, 2016
• Study Start: October 1, 2016
• Primary Completion: May 1, 2020
• Study Completion: January 1, 2021
• Last Updated: August 17, 2021

Record last verified: 2021-08

Locations

CA (1)