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Trial registered on ANZCTR


Registration number
ACTRN12619001317189
Ethics application status
Approved
Date submitted
31/07/2019
Date registered
26/09/2019
Date last updated
2/12/2019
Date data sharing statement initially provided
26/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Ablative, fractional CO2 laser and medical needling to enhance burn scarring in children: A pilot randomised trial
Scientific title
The efficacy of ablative, fractional CO2 laser and medical needling to enhance burn scar remodelling in children: A pilot randomised trial, feasibility and acceptability study
Secondary ID [1] 297562 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Burn scars 311795 0
Condition category
Condition code
Skin 310415 310415 0 0
Other skin conditions
Injuries and Accidents 312403 312403 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 DEEP FX, SCAAR FX setting; ARTG no. 182239. The dosage applied by the laser intervention will be 120-130mJ, 1% density, square size 10, 250Hz, 1 pass with minimal overlapping. 120MJ will be the dose applied to scarred skin without contractures or tightness and 130MJ will be the dose applied to areas with contractures or tightness. The dose applied and areas these doses were applied will be recorded as part of a fidelity checklist. Blood and extradite may also aid in the healing process thus will not be removed during the theatre session. Delivered individually in 3 sessions, each 1-month apart at 2-months post-burn, 4-months post-burn and 6-months post-burn. The site will be covered with a Sorbact dressing immediately post-intervention until removal approximately 24 hours later and following that paraffin 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 factsheet will be provided to the caregivers of participants with post-procedural information regarding ongoing treatment, aftercare of the treatment site, potential adverse effects, and staff contact details. Standard care is as per the standard care group 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.

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). For sites such as small fingers and curved sites where the roller is difficult to apply, a dermapen will be used for the needling. Blood and extradite may also aid in the healing process thus will not be removed during the theatre session. Delivered individually in 3 sessions, each 2-months apart at 2-months post-burn, 4-months post-burn and 6-months post-burn. The site will be covered with a Sorbact dressing immediately post-intervention until removal approximately 24 hours later and following that paraffin 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. Standard care is as per the standard care group with the exception of the medical needling intervention which will not be delivered to this group from 6-months to 12-months post-burn (the study endpoint). with the exception of brief cessation of standard care interventions post-operatively. In addition there will be a short period of cessation of standard care interventions post-operatively. Silicone and pressure garment therapy will be recommenced after re-epithelialisation post needling. A factsheet will be provided to the caregivers of participants with post-procedural information regarding ongoing treatment, aftercare of the treatment site, potential adverse effects, and staff contact details.

The medical needling or ablative fractional CO2 laser component of intervention arm 1 and intervention arm 2 will be delivered in an operating theatre in a major metropolitan children's hospital.

Intervention arm 3 - standard care: Standard care may include pressure garments, silicone products, skin or scar massage, exercises, moisturisers, education regarding sun protection, medical needling (as per intervention arm 2 but from 6-months post-burn). The dose and type of interventions provided is determined by treating health professionals. One or more of these interventions may be provided. The medical needling component of the intervention is delivered in an operating theatre in a major metropolitan children's hospital.
Intervention code [1] 313795 0
Treatment: Devices
Intervention code [2] 313796 0
Treatment: Surgery
Comparator / control treatment
Active control: Standard care as determined by treating health professionals up to 6-months post-burn. This will include use of the following interventions: traditional scar management modalities such as pressure garments, silicone gels, scar massage, exercise, application of moisturiser and skin protection. At 6-months or more post-burn the active control group will be offered medical needling as part of their usual care which is standard practice in the study setting.
Control group
Active

Outcomes
Primary outcome [1] 319283 0
Scar thickness measured using high frequency ultrasound.
Timepoint [1] 319283 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn prior to each intervention appointment and at 9, 12 and 14-months (primary endpoint) post-burn.
Secondary outcome [1] 367652 0
Therapist’s report of scar height using the Patient Observer Scar Assessment Scale.
Timepoint [1] 367652 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn (prior to each session of intervention); and at 9, 12 and 14-months post-burn.
Secondary outcome [2] 367653 0
Itch severity: measured using a 0 to 10 numeric rating scale for the last month.
Timepoint [2] 367653 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn (prior to each session of intervention); and at 9, 12 and 14-months post-burn.
Secondary outcome [3] 367654 0
Scar-specific health-related quality of life (including sensory symptoms) measured using the Brisbane Burn Scar Impact Profile.
Timepoint [3] 367654 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn (prior to each session of intervention); and at 9, 12 and 14-months post-burn.
Secondary outcome [4] 367655 0
Incremental cost per QALY measured using the CHU-9D, trial intervention resource use, and healthcare resource use (including co-interventions).
Timepoint [4] 367655 0
12-month time horizon
Secondary outcome [5] 367657 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 [5] 367657 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), 4 and 6 months post-burn (prior to each session of intervention) and at 9, 12 and 14-months post-burn.
Secondary outcome [6] 367659 0
Time to scar maturation in days from the burn injury to scar maturation, which is usually the end of active treatment or time of discontinuation or reduced length of application of scar interventions is recommended by health professionals. As reported by treating health professionals.
Timepoint [6] 367659 0
Any time up to 18-months post-burn.
Secondary outcome [7] 367660 0
Scar and skin microbiome as measured using swabs to extract total RNA and perform 16S rRNA sequencing. This is an exploratory outcome.
Timepoint [7] 367660 0
Measured at baseline (2-months post-burn, prior to randomisation), 4 and 6-months post-burn prior to procedures and usual care.
Secondary outcome [8] 367661 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, and swelling and bruising for 7 to 10 days after the procedure.

Adverse effects to the medical needling intervention may include swelling, tingling, and redness for a day or more.
Timepoint [8] 367661 0
Measured after intervention at 2, 4 and 6 months post-burn, and continuously throughout the trial. Will be self-reported or as reported by treating health professionals.
Secondary outcome [9] 367662 0
Serum proteins linked to wound and scar outcomes measured using a blood sample taken when children are under a light anaesthetic. This is an exploratory outcome.
Timepoint [9] 367662 0
Prior to procedures at 2, 4 and 6-months in the laser and medical needling groups who undergo procedures.
Secondary outcome [10] 373792 0
Pain severity: measured using a 0 to 10 numeric rating scale for the last month.
Timepoint [10] 373792 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn (prior to each session of intervention); and at 9, 12 and 14-months post-burn.
Secondary outcome [11] 373798 0
Caregiver’s report of their child's overall opinion of scar appearance using the Patient Observer Scar Assessment Scale.
Timepoint [11] 373798 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn (prior to each session of intervention); and at 9, 12 and 14-months post-burn.
Secondary outcome [12] 373799 0
Caregiver’s report of their child's scar stiffness using the Patient Observer Scar Assessment Scale.
Timepoint [12] 373799 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn (prior to each session of intervention); and at 9, 12 and 14-months post-burn.
Secondary outcome [13] 373800 0
Children's report of overall scar appearance (if the child is aged 8 years or older) will be measured using the patient report of the Patient Observer Scar Assessment Scale.
Timepoint [13] 373800 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn (prior to each session of intervention); and at 9, 12 and 14-months post-burn.
Secondary outcome [14] 373801 0
Scar vascularity measured using the DSM-II ColorMeter a* parameter.
Timepoint [14] 373801 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn (prior to each session of intervention); and at 9, 12 and 14-months post-burn.
Secondary outcome [15] 373802 0
Scar pigmentation measured using the DSM-II ColorMeter L* parameter.
Timepoint [15] 373802 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn (prior to each session of intervention); and at 9, 12 and 14-months post-burn.
Secondary outcome [16] 373807 0
Scar pigmentation measured using the DSM-II Colormeter melanin parameter.
Timepoint [16] 373807 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn (prior to each session of intervention); and at 9, 12 and 14-months post-burn.
Secondary outcome [17] 375235 0
Generic health-related quality of life of children will be reported using the Child Health Utility-9D.
Timepoint [17] 375235 0
This outcome will be measured at baseline (2-months post-burn; prior to randomisation), at 2, 4 and 6 months post-burn (prior to each session of intervention); and at 9, 12 and 14-months post-burn.

Eligibility
Key inclusion criteria
Participants will be aged 16 years or younger at the time of recruitment and have:
Hypertrophic burn scarring of any size at up to 2-months post-burn; and be:
• Able to attend the study sites for treatment and follow-up;
• Hypertrophic scars with functional and/or cosmetic implications determined by patient-report on the Brisbane Burn Scar Impact Profile.
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Hypersensitivity to light/laser treatments as laser therapy would be contraindicated;
• Co-morbid skin disorders (i.e., 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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation (1:1 ratio)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Six participants in each arm are required to achieve a power of 80% (effect size 1.79) using alpha of 0.05 for the primary outcome of scar thickness. To account for expected drop-out of 30% at 12 months post-burn an additional 9 participants are required (3 per group). We will attempt to recruit at least 36 participants in a 6-month timeframe to permit inferential analysis of the secondary outcome measures.

Primary outcome comparison at 12 months post-burn based on scar thickness scores will be conducted between the laser therapy and CAU groups and between the medical needling and CAU groups using general linear mixed models for repeated measures, with terms included for stratification and confounding variables (if any significant differences (p<0.01) between groups are identified for key sociodemographic and clinical characteristics at baseline). 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 4-months, 6-months, 9-months 12-months and 14-months post-burn using linear mixed models or generalised estimating equations where appropriate. Pre-specified subgroup analyses will be conducted to examine the influence of the child’s age, gender, body location of the treated scar, skin type, and visibility of the scar on treatment response using scar thickness, overall opinion of the scar appearance and sensation 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
25/11/2019
Actual
Date of last participant enrolment
Anticipated
17/04/2020
Actual
Date of last data collection
Anticipated
18/06/2021
Actual
Sample size
Target
36
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 14228 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 27221 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 302115 0
Charities/Societies/Foundations
Name [1] 302115 0
Children's Hospital Foundation
Country [1] 302115 0
Australia
Funding source category [2] 302131 0
Hospital
Name [2] 302131 0
Queensland Children's Hospital
Country [2] 302131 0
Australia
Funding source category [3] 302132 0
University
Name [3] 302132 0
The University of Queensland
Country [3] 302132 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
St Lucia, Brisbane, QLD 4072
Country
Australia
Secondary sponsor category [1] 301987 0
Hospital
Name [1] 301987 0
Queensland Children's Hospital
Address [1] 301987 0
501 Stanley St, South Brisbane, Queensland 4101
Country [1] 301987 0
Australia
Other collaborator category [1] 280580 0
Hospital
Name [1] 280580 0
Fiona Stanley Children's Hospital
Address [1] 280580 0
11 Robin Warren Dr, Murdoch WA 6150
Country [1] 280580 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302794 0
Children's Health Queensland Hospital and Health Service Ethics Committee
Ethics committee address [1] 302794 0
Ethics committee country [1] 302794 0
Australia
Date submitted for ethics approval [1] 302794 0
Approval date [1] 302794 0
02/08/2018
Ethics approval number [1] 302794 0
HREC/18/QRCH/165
Ethics committee name [2] 302814 0
The University of Queensland Ethics Committee
Ethics committee address [2] 302814 0
Ethics committee country [2] 302814 0
Australia
Date submitted for ethics approval [2] 302814 0
Approval date [2] 302814 0
29/10/2018
Ethics approval number [2] 302814 0
2018002187-HREC/18/QRCH/165

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

Contacts
Principal investigator
Name 91426 0
Dr Zephanie Tyack
Address 91426 0
Centre for Children's Burns and Trauma Research,
Children's Health Research Centre
62 Graham St
South Brisbane
QLD 4101
Country 91426 0
Australia
Phone 91426 0
+61 7 30697446
Fax 91426 0
Email 91426 0
z.tyack@uq.edu.au
Contact person for public queries
Name 91427 0
Zephanie Tyack
Address 91427 0
Centre for Children's Burns and Trauma Research,
Children's Health Research Centre
62 Graham St
South Brisbane
QLD 4101
Country 91427 0
Australia
Phone 91427 0
+61 7 30697446
Fax 91427 0
Email 91427 0
z.tyack@uq.edu.au
Contact person for scientific queries
Name 91428 0
Zephanie Tyack
Address 91428 0
Centre for Children's Burns and Trauma Research,
Children's Health Research Centre
62 Graham St
South Brisbane
QLD 4101
Country 91428 0
Australia
Phone 91428 0
+61 7 30697446
Fax 91428 0
Email 91428 0
z.tyack@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval for this small pilot trial does not cover sharing of individual participant data. The Children's Health Queensland Human Research Ethics Committee can be contacted for requests regarding the possibility of accessing this data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4028Study protocolIt is intended that the study protocol will be submitted for publication prior to the commencement of the trial and published prior to data collection being completed.   



Results publications and other study-related documents

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