Fractional CO2 Laser Treatment of Hypertrophic Scars

Summary

Executive Summary

Hypertrophic scars are irregular, raised scars that can cause debilitating symptoms including pain, pruritus, and restricted movement in nearby joints. There are also often significant psychosocial elements with these scars that are especially significant in the vulnerable pediatric population and their parents. Current scar treatment modalities are limited. In recent years, the advent of ablative fractional laser (AFL) resurfacing technology has shown great promise but there remains a need to expand high-level evidence and develop optimal laser treatment parameters for patients.

In this study, the investigators aim to evaluate the efficacy of ablative fractional CO2 laser treatment of hypertrophic scars in children and define a set of laser treatment parameters to develop a treatment protocol that maximizes the safety and efficacy of AFL therapy in the pediatric population. This will be a prospective split-scar clinical trial at Alberta Children's Hospital. A sample size of 44 scars will be sufficient to detect a clinically significant improvement in total POSAS score, our primary outcome measure. Children (age 1- 17) who present with hypertrophic scarring following an acute injury or burn may be included in the study. All patients will receive standard scar treatment modalities and will be followed by our plastic surgery team and rehabilitation team. Each scar being studied will be split into two halves which will be assigned a unique "Site ID" that will be recorded in a data collection sheet and used to identify scars for assessment. All laser treatments will be performed by a single surgeon using the UltraPulse CO2 Laser (Lumenis, Israel) and will be done at the Alberta Children's Hospital in the main operating room under a general anesthetic. Patients will receive laser treatments at 4 to 8-week intervals for a total of 3 sessions. A combination of the SCAAR FX and Deep FX treatment modes, with or without Active FX treatment mode, will be used according to individual patient and scar characteristics.

Data collection includes demographic data and original burn data. Assessment tools including the POSAS and SCAR-Q questionnaires, clinical photographs, and cutometer will be used at various time points to document changes in scar appearance and pathology over the study period. Mean values for the cutometer measurements as well as the POSAS and SCAR-Q questionnaires will be compared between laser-treated and control scar sites. Each of these datasets will be tested for normality using the Shapiro-Wilk test. Non-parametric data will be compared using Wilcoxon signed-rank test and parametric data will be compared using Student's t-tests.

Conditions

• Cicatrix, Hypertrophic

Interventions

DEVICE

Fractional CO2 laser treatment -

UltraPulse CO2 Laser (Lumenis, Israel). Patients will receive laser treatments at 4 to 8-week intervals for a total of 3 sessions. A combination of the SCAAR FX and Deep FX treatment modes, with or without Active FX treatment mode, will be used according to individual patient and scar characteristics. For SCAAR FX, the settings include energy (70-150mJ), density (1-5%), and frequency (150-250Hz).For Deep FX, the settings include energy (12.5-22.5mJ), density (5-15%) and frequency (300-600Hz). For Active FX, the settings include energy (80-125mJ), density (2-3%) and frequency (100-150Hz)

Sponsors & Collaborators

• University of Calgary

  lead OTHER

Principal Investigators

• Frankie Fraulin, MD · Clinical Associate Professor

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

17 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2020-11-01

Primary Completion

2023-11-30

Completion

2023-11-30

FDA Device

Yes

Countries

• Canada

Study Locations