Fractional CO2 Laser Treatment of Hypertrophic Scars

NCT04236167 | Terminated DMC FDA Device

• 1 other identifier: REB17-2362
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

laser; fractional CO2 laser

Outcome Measures

Primary Outcomes (3)

• Change in POSAS score

  Unabbreviated title: Patient and Observer Scar Assessment Scale. Total minimum score = 14 maximum score = 140. Higher scores indicate worse outcome.

  Through study completion, an average of 8 months

• Change in SCAR-Q score

  Unabbreviated title = SCAR - Questionnaire (Patient reported outcome measure) Minimum score 29. Maximum 116. Higher score indicates worse outcome.

  Through study completion, an average of 8 months

• Change in Cutometer measurements

  MPA 580 Cutometer (Courage + Khazaka electronic GmbH, Germany) to assess the mechanical properties of the skin.

  Through study completion, an average of 8 months

Secondary Outcomes (1)

• Change in appearance on Clinical Photographs of scars

  Through study completion, an average of 8 months

Study Arms (2)

Control half of scar

NO INTERVENTION

one half of the scar will receive standard scar treatment with topical products and pressure garments, but no ablative fractional CO2 laser

Laser treatment half of scar

EXPERIMENTAL

The other half of the scar will receive standard scar treatment with topical products and pressure garments and, in addition, will receive ablative fractional CO2 laser treatment

Device: Fractional CO2 laser treatment -

Interventions

Fractional CO2 laser treatment - DEVICE

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)

Laser treatment half of scar

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children (age 1- 17) who present with hypertrophic scarring following an acute injury or burn, with stable closed scars at least 3 months post wound closure.

You may not qualify if:

• Outside of age limits described above.
• Contraindications to general anesthesia.
• Open wounds in scars.
• Active infection.

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B6A8, Canada

Location

Related Publications (18)

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  PMID: 12528792 BACKGROUND

• Tredget EE, Levi B, Donelan MB. Biology and principles of scar management and burn reconstruction. Surg Clin North Am. 2014 Aug;94(4):793-815. doi: 10.1016/j.suc.2014.05.005.

  PMID: 25085089 BACKGROUND

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  PMID: 12781605 BACKGROUND

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  PMID: 17318467 BACKGROUND

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  PMID: 20100273 BACKGROUND

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  PMID: 23542846 BACKGROUND

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  PMID: 31225898 BACKGROUND

• Klassen AF, Ziolkowski N, Mundy LR, Miller HC, McIlvride A, DiLaura A, Fish J, Pusic AL. Development of a New Patient-reported Outcome Instrument to Evaluate Treatments for Scars: The SCAR-Q. Plast Reconstr Surg Glob Open. 2018 Apr 24;6(4):e1672. doi: 10.1097/GOX.0000000000001672. eCollection 2018 Apr.

  PMID: 29876160 BACKGROUND

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  PMID: 18388576 BACKGROUND

• Draaijers LJ, Tempelman FR, Botman YA, Tuinebreijer WE, Middelkoop E, Kreis RW, van Zuijlen PP. The patient and observer scar assessment scale: a reliable and feasible tool for scar evaluation. Plast Reconstr Surg. 2004 Jun;113(7):1960-5; discussion 1966-7. doi: 10.1097/01.prs.0000122207.28773.56.

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• Poetschke J, Dornseifer U, Clementoni MT, Reinholz M, Schwaiger H, Steckmeier S, Ruzicka T, Gauglitz GG. Ultrapulsed fractional ablative carbon dioxide laser treatment of hypertrophic burn scars: evaluation of an in-patient controlled, standardized treatment approach. Lasers Med Sci. 2017 Jul;32(5):1031-1040. doi: 10.1007/s10103-017-2204-z. Epub 2017 Apr 12.

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• Lapidoth M, Halachmi S, Cohen S, Amitai DB. Fractional CO2 laser in the treatment of facial scars in children. Lasers Med Sci. 2014 Mar;29(2):855-7. doi: 10.1007/s10103-013-1305-6. Epub 2013 Mar 26.

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• Miletta N, Siwy K, Hivnor C, Clark J, Shofner J, Zurakowski D, Anderson RR, Lee K, Donelan M. Fractional Ablative Laser Therapy is an Effective Treatment for Hypertrophic Burn Scars: A Prospective Study of Objective and Subjective Outcomes. Ann Surg. 2021 Dec 1;274(6):e574-e580. doi: 10.1097/SLA.0000000000003576.

  PMID: 31469749 BACKGROUND

MeSH Terms

Conditions

Cicatrix, Hypertrophic

Condition Hierarchy (Ancestors)

Cicatrix; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Frankie Fraulin, MD

  Clinical Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: One part of the outcomes will be assessment of clinical photographs of the scars. The assessor will be blinded to which part of the scar received the laser treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy Head, Department of Surgery

Model Details: Prospective split scar study

Study Record Dates

• First Submitted: January 12, 2020
• First Posted: January 22, 2020
• Study Start: November 1, 2020
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)