Cicatrix, HypertrophicNCT02707627
Laser Therapy for Pediatric Burn Scars
An observational study of Cicatrix, Hypertrophic and Burns, run by The Hospital for Sick Children at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cicatrix, Hypertrophic, Burns
- What is being tested?
- Laser Therapy
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2016to Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Eligible participants will be pediatric patients with hypertrophic scars requiring treatment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled Trial Investigating the Use of Laser Therapy to Improve Pediatric Burn Scars.
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
- Being tested
- Laser Therapy
- Keywords
- Pediatric, Laser, Burn, Scar, Photothermolysis
- Medical subject headings
- Cicatrix, Hypertrophic, Burns, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser TherapyDevice
Laser therapy is a technology that can be used to treat hypertrophic burn scars.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (month 0) to month 12
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: Baseline(month 0) to month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startOct 2016
- Primary completionMay 2020
- Study completionJan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cicatrix, HypertrophicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joel Fish, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707627
- Sponsor's protocol ID
- Hospital for Sick Children
- Status last verified
- Aug 2021
- First submitted
- 3 Mar 2016
- Last updated
- 17 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Trial Investigating the Use of Laser Therapy to Improve Pediatric Burn Scars.
- ClinicalTrials.gov ID
- NCT02707627
- Acronym / sponsor ID
- Hospital for Sick Children
- Conditions
- Cicatrix, Hypertrophic, Burns
- Keywords
- Pediatric, Laser, Burn, Scar, Photothermolysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- May 2020 (actual)
- Study completion
- Jan 2021 (actual)
- First posted
- 14 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser Therapy | – | Device: Laser TherapyParticipants 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Eligible participants will be pediatric patients with hypertrophic scars requiring treatment.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laser TherapyLaser therapy is a technology that can be used to treat hypertrophic burn scars. | Device | Laser Therapy |
Primary outcome
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.
5 secondary outcomes
Patient and Observer Scar Assessment Scale Score
Time frame: Baseline (month 0) to month 12
Scar thickness
Time frame: Baseline(month 0) to month 12
Scar stiffness measured by the DermaLab Combo® skin analysis device
Time frame: Baseline(month 0) to month 12
Scar stiffness measured by ultrasound elastographgy
Time frame: Baseline(month 0) to month 12
Scar colour
Time frame: Baseline(month 0) to month 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cicatrix, Hypertrophic and Burns, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vancouver Scar Scale Score (time frame: Baseline (month 0) to month 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.