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Trial registered on ANZCTR


Registration number
ACTRN12621000288820
Ethics application status
Approved
Date submitted
18/01/2021
Date registered
16/03/2021
Date last updated
21/03/2022
Date data sharing statement initially provided
16/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised controlled trial of ablative fractional CO2 laser and medical needling in children with burn scars
Scientific title
A randomised controlled trial of ablative fractional CO2 laser and medical needling in children with burn scars
Secondary ID [1] 302972 0
None
Universal Trial Number (UTN)
U1111-1262-4691
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn scars 320026 0
Condition category
Condition code
Skin 317947 317947 0 0
Other skin conditions
Injuries and Accidents 317948 317948 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention arm 1 - Ablative fractional CO2 laser therapy + standard care: Ablative fractional CO2 laser therapy will be delivered by a surgeon to each participant under a general anaesthetic using a Lumenis Ablative Fractional CO2 laser with SCAAR FX setting; ARTG no. 182239. The dosage applied by the laser intervention will be delivered at one of three depth settings (1-2mm, 60-70mj – shallow skin lesion, 2-3mm, 70-120mj – medium skin lesion, >3mm, 120-150mj – deep skin lesion), which will be determined by ultrasound measurement of scar thickness pre-operatively; and with a standard device setting of 1% density, square size 10, 250Hz, 1 pass with minimal overlapping. The dose applied and areas these doses were applied will be recorded as part of a fidelity checklist. Delivered individually over 1 session at 6 months or more post-burn. Following the intervention any blood and/or exudate will be cleaned, the site will be covered with a Sorbact dressing immediately post-intervention for 24 hours and following that QV intensive moisturising cream will be applied as many times a day as needed to prevent dryness of the skin site. The duration of the intervention will vary for each participant and will be determined by the treating surgeon but will usually be for no longer than 1 hour under general anaesthetic. A hospital-specific factsheet will be provided to the caregivers of participants with post-procedural information (e.g. ongoing treatment, aftercare of the treatment site). Standard care (see below) will continue with the exception of brief cessation of standard care interventions post-operatively. Silicone and pressure garment therapy will be recommenced after re-epithelialisation post laser intervention where appropriate.

Intervention arm 2 - Medical needling + standard care: Medical needling will be delivered mechanically by a surgeon to each patient under a general anaesthetic using 3mm needles attached to a roller (Environ Roll-CIT 3mm). The dose applied and areas these doses were applied will be recorded as part of a fidelity checklist. Delivered individually in 1 session at 6-months or more post-burn. Following the intervention any blood and/or exudate will be cleaned, the site will be covered with a Sorbact dressing immediately post-intervention for 24 hours and following that QV intensive moisturising cream will be applied as many times a day as needed to prevent dryness of the skin site. The duration of the intervention will vary for each participant and will be determined by the treating surgeon but will usually be for no longer than 1 hour under general anaesthetic. A hospital-specific factsheet will be provided to the caregivers of participants with post-procedural information (e.g. ongoing treatment, aftercare of the treatment site). Standard care (see below) will continue with the exception of brief cessation of standard care interventions post-operatively. Silicone and pressure garment therapy will be recommenced after re-epithelialisation post needling as appropriate.

NB: Standard care may include pressure garments, silicone products, skin or scar massage, exercises, moisturisers, education regarding sun protection. The dose and type of interventions provided is determined by treating health professionals. One or more of these interventions may be provided.
Intervention code [1] 319260 0
Treatment: Devices
Intervention code [2] 319261 0
Treatment: Surgery
Comparator / control treatment
There is no placebo group in this study as we are comparing one intervention to the other. Therefore the laser therapy intervention (reference comparator) will be compared to medical needling.
Control group
Active

Outcomes
Primary outcome [1] 325953 0
Scar thickness measured using high frequency ultrasound
Timepoint [1] 325953 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 1 month and 3 months post-procedure (primary endpoint).
Secondary outcome [1] 389644 0
Scar pigmentation measured using the DSM-II ColorMeter L* parameter
Timepoint [1] 389644 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 1 month and 3 months post-procedure.
Secondary outcome [2] 389645 0
Scar pigmentation measured using the DSM-II Colormeter melanin parameter.
Timepoint [2] 389645 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 1 month and 3 months post-procedure.
Secondary outcome [3] 389646 0
Burn-scar specific, health-related quality of life (child itch severity). Brisbane Burn Scar Impact Profile itch items. Reported by parent proxies or children aged 8 years or older.
Timepoint [3] 389646 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 48 hours, 1 month and 3 months post-procedure.
Secondary outcome [4] 390645 0
Burn-scar specific, health-related quality of life (child pain severity). Brisbane Burn Scar Impact Profile pain items. Reported by parent proxies or children aged 8 years or older.
Timepoint [4] 390645 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 48 hours, 1 month and 3 months post-procedure.
Secondary outcome [5] 390646 0
Burn-scar specific, health-related quality of life (perceived scar tightness). Brisbane Burn Scar Impact Profile scar tightness items. Reported by parent proxies or children aged 8 years or older.
Timepoint [5] 390646 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at a 1 month and 3 months post-procedure
Secondary outcome [6] 390647 0
Burn-scar specific, health-related quality of life (child appearance). Brisbane Burn Scar Impact Profile appearance subscale. Reported by parent proxies or children aged 8 years or older.
Timepoint [6] 390647 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at a 1 month and 3 months post-procedure
Secondary outcome [7] 390648 0
Burn-scar specific, health-related quality of life (child daily living). Brisbane Burn Scar Impact Profile daily living subscale. Reported by parent proxies or children aged 8 years or older.
Timepoint [7] 390648 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at a 1 month and 3 months post-procedure
Secondary outcome [8] 390649 0
Generic health-related quality of life: CHU-9D utility measure. Reported by parent proxies or children aged 8 years or older.
Timepoint [8] 390649 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 1 month and 3 months post-procedure.
Secondary outcome [9] 390650 0
School functioning: PEDS-QL school functioning subscale. Reported by children aged 8 years or older.
Timepoint [9] 390650 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and 1 month and 3 months post-procedure.
Secondary outcome [10] 390651 0
Days missed from school or daycare: a single question for the number of days missed from school or daycare reported by parent proxies or children aged 8 years or older
Timepoint [10] 390651 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and 1 month and 3 months post-procedure.
Secondary outcome [11] 390652 0
Days missed from employment: a single question for number of days missed from employment self-reported by a caregiver.
Timepoint [11] 390652 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and 1 month and 3 months post-procedure.
Secondary outcome [12] 390653 0
Satisfaction with scar response to treatment measured using a 0 to 10 numeric rating scale. Data will be gathered from patients aged 8 years and older and all parents/caregivers.
Timepoint [12] 390653 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 1 month and 3 months post-procedure.
Secondary outcome [13] 390654 0
Adverse effects to the laser intervention may include redness, changes in pigmentation (hyperpigmentation or hypopigmentation), a hypersensitive scar, blistering and irritation around hair follicles, infection, scarring, swelling and bruising for 7 to 10 days after the procedure. This outcome will be measured by participant/proxy self-report using a study-specific questionnaire.

Adverse effects to the medical needling intervention may include swelling, tingling, and redness for a day or more.
Timepoint [13] 390654 0
Measured after intervention, at 48 hours, 1 month and 3 months post-procedure and continuously throughout the trial. Will be measured by participant/proxy-self report using a free text option in electronic questionnaires or as verbally reported to researchers by treating health professionals.
Secondary outcome [14] 390666 0
Burn-scar specific, health-related quality of life (child friendships and social interaction). Brisbane Burn Scar Impact Profile friendships and social interaction subscale. Reported by parent proxies or children aged 8 years or older.
Timepoint [14] 390666 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 1 month and 3 months post-procedure.
Secondary outcome [15] 390668 0
Burn-scar specific, health-related quality of life (child mobility). Brisbane Burn Scar Impact Profile mobility subscale. Reported by parent proxies or children aged 8 years or older.
Timepoint [15] 390668 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 1 month and 3 months post-procedure.
Secondary outcome [16] 390669 0
Burn scar specific health-related quality of life (child overall impact) - Brisbane Burn Scar Impact Profile overall impact subscale
Timepoint [16] 390669 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 1 month and 3 months post-procedure.
Secondary outcome [17] 390670 0
Burn scar specific health-related quality of life (child emotional reactions) - Brisbane Burn Scar Impact Profile emotional reactions subscale
Timepoint [17] 390670 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 1 month and 3 months post-procedure.
Secondary outcome [18] 390671 0
Burn scar specific health-related quality of life (child physical symptoms) - Brisbane Burn Scar Impact Profile physical symptoms subscale.
Timepoint [18] 390671 0
This outcome will be measured at baseline (6-months or more post-burn; prior to randomisation) and at 1 month and 3 months post-procedure.

Eligibility
Key inclusion criteria
Participants will be aged 18 years or younger at the time of recruitment and have:
• Hypertrophic burn scarring of any size at 6-months or more post-burn with functional and/or cosmetic implications determined by patient-report on the Brisbane Burn Scar Impact Profile.
• Able to attend the study sites for treatment and follow-up.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will not be included if they have:
• Previously received laser therapy or medical needling as part of treatment for their burn scars
• Hypersensitivity to light/laser treatments as laser therapy would be contraindicated;
• Co-morbid skin disorders (i.e., current eczema, dermatitis, skin cancer) as these could confound wound healing and scarring post-intervention.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation will be used in the study with scar thickness of the treatment site (<2mm, greater than or equal to 2mm) as the unit of stratification. Randomisation will be at the level of the individual in random blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Thirty participants in each arm are required to be able to detect a between-group effect
size of 0.75 standard deviation Z-scores or greater with 80% power (alpha=0.05) for the
primary outcome of ultrasound scar thickness. To account for expected 15% attrition 1-
month post-procedure, an additional 10 participants are required. In total we will recruit at least 70 participants (35 participants per group) over a 7-month timeframe. It is expected that the study interventions will be delivered over a 10 month period, with a 3 month post-intervention follow-up.

Primary outcome comparison post-procedure will be based on the change in ultrasound scar thickness compared between the laser therapy and medical needling groups using generalised linear mixed models for repeated measures. The primary outcome comparison will be conducted using an intention to treat approach. This will be compared to a per-protocol approach. A sensitivity analysis will be conducted using imputation techniques to replace non-ignorable data that is considered to be missing at random over the follow-up period, to determine whether bias is likely in the complete case analysis. Secondary outcome comparisons will be conducted at 1-month and 3-months post procedure using linear mixed models or generalised estimating equations where appropriate. Prespecified secondary analyses will examine the influence of the child’s age, gender, body location of the treated scar, skin type, and scar visibility and previous surgical intervention on the treatment response using the outcomes of ultrasound scar thickness, itch, and overall opinion of the scar appearance where possible. A sensitivity analysis will investigate whether a mean difference measure of scar thickness, vascularity and pigmentation between the selected scarred skin and an uninjured contralateral skin site changes the results of the primary approach that uses the selected scarred skin alone. Descriptive results may be reported where the assumptions of other chosen analyses are not met. Qualitative data will be collected to further investigate the physical and sensory scar outcomes, evidence of the laser and medical needling intervention group allocation, acceptability of the interventions and patient-reported outcome measures, and feasibility of the interventions. Framework analysis will be used to analyse the qualitative findings.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2021
Actual
29/06/2021
Date of last participant enrolment
Anticipated
1/11/2022
Actual
Date of last data collection
Anticipated
1/01/2023
Actual
Sample size
Target
70
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18164 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 32165 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 307390 0
Charities/Societies/Foundations
Name [1] 307390 0
Children's Hospital Foundation
Country [1] 307390 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Child Health Research Centre
62 Graham St.
South Brisbane QLD 4101
Country
Australia
Secondary sponsor category [1] 308047 0
Hospital
Name [1] 308047 0
Children's Health Queensland
Address [1] 308047 0
Queensland Children's Hospital
501 Stanley St, South Brisbane QLD 4101
Country [1] 308047 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307477 0
The Children’s Health Queensland Human Research Ethics Committee
Ethics committee address [1] 307477 0
Ethics committee country [1] 307477 0
Australia
Date submitted for ethics approval [1] 307477 0
02/08/2018
Approval date [1] 307477 0
01/02/2021
Ethics approval number [1] 307477 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107366 0
Dr Zephanie Tyack
Address 107366 0
The University of Queensland
62 Graham St.
South Brisbane QLD 4101
Country 107366 0
Australia
Phone 107366 0
+61 7 3069 7343
Fax 107366 0
Email 107366 0
[email protected]
Contact person for public queries
Name 107367 0
Zephanie Tyack
Address 107367 0
The University of Queensland
62 Graham St.
South Brisbane QLD 4101
Country 107367 0
Australia
Phone 107367 0
+61 7 3069 7343
Fax 107367 0
Email 107367 0
[email protected]
Contact person for scientific queries
Name 107368 0
Zephanie Tyack
Address 107368 0
The University of Queensland
62 Graham St.
South Brisbane QLD 4101
Country 107368 0
Australia
Phone 107368 0
+61 7 3069 7343
Fax 107368 0
Email 107368 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10271Study protocol    This document will be uploaded once published.
10272Statistical analysis plan    This document will be uploaded prior to the end of... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.