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Trial record 1 of 1 for:    Recruiting, Not yet recruiting Studies | Laser Therapy for Pediatric Burn Scars
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Laser Therapy for Pediatric Burn Scars

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ClinicalTrials.gov Identifier: NCT02707627
Recruitment Status : Recruiting
First Posted : March 14, 2016
Last Update Posted : November 20, 2020
Sponsor:
Information provided by (Responsible Party):
Joel Fish, The Hospital for Sick Children

Study Description
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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.

Condition or disease Intervention/treatment
Cicatrix, Hypertrophic Burns Device: Laser Therapy

Study Design
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Study Type : Observational
Estimated Enrollment : 54 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Controlled Trial Investigating the Use of Laser Therapy to Improve Pediatric Burn Scars.
Study Start Date : October 2016
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Burns Scars

Groups and Cohorts
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Group/Cohort Intervention/treatment
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
Laser therapy is a technology that can be used to treat hypertrophic burn scars.


Outcome Measures
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Primary Outcome Measures :
  1. Vancouver Scar Scale Score [ Time Frame: Baseline (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 :
  1. Patient and Observer Scar Assessment Scale Score [ Time Frame: Baseline (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.

  2. Scar thickness [ Time Frame: Baseline(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.

  3. Scar stiffness measured by the DermaLab Combo® skin analysis device [ Time Frame: Baseline(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).

  4. Scar stiffness measured by ultrasound elastographgy [ Time Frame: Baseline(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.

  5. Scar colour [ Time Frame: Baseline(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)


Eligibility Criteria
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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Eligible participants will be pediatric patients with hypertrophic scars requiring treatment.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707627


Contacts
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Contact: Jennifer Zuccaro 416-813-7654 ext 203018 jennifer.zuccaro@sickkids.ca

Locations
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Canada, Ontario
Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Contact: Jennifer Zuccaro    4168137654 ext 203018    jennifer.zuccaro@sickkids.ca   
Sponsors and Collaborators
The Hospital for Sick Children
More Information
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Responsible Party: Joel Fish, Medical Director, Burn Program, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02707627    
Other Study ID Numbers: Hospital for Sick Children
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: November 20, 2020
Last Verified: November 2020
Keywords provided by Joel Fish, The Hospital for Sick Children:
Pediatric
Laser
Burn
Scar
Photothermolysis
Additional relevant MeSH terms:
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Cicatrix
Cicatrix, Hypertrophic
Burns
 Wounds and Injuries
Fibrosis
Pathologic Processes