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Trial registered on ANZCTR


Registration number
ACTRN12616001100482
Ethics application status
Approved
Date submitted
5/08/2016
Date registered
15/08/2016
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Date results information initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing the effectiveness of topical silicone gel and pressure garment therapy interventions to prevent and manage burn scars in children.
Scientific title
Effectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: A randomised controlled trial.
Secondary ID [1] 288598 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric burns scars 297769 0
Condition category
Condition code
Physical Medicine / Rehabilitation 297924 297924 0 0
Occupational therapy
Injuries and Accidents 299753 299753 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparing the effectiveness of topical silicone gel and pressure garment therapy for the prevention and management of paediatric burn scars.
Management of the acute burn will be conducted by the burns multidisciplinary team as per standard care. Potential participants referred to scar management will be approached for inclusion in the study and if consent is received, participants will be randomly allocated to receive either topical silicone gel (arm 1), pressure garment therapy (arm 2) or a combined topical silicone gel and pressure garment therapy intervention (arm 3). The intervention period is for up to 12 months post-burn or burn scar reconstruction. At the end of the last follow-up (12 months post-burn) ongoing scar management will be as per standard practice and will continue until scar maturation. Scar management appointments will be scheduled within the hospital setting according to clinical need, as determined by the treating Occupational Therapist. Research appointments will coincide with Occupational Therapy appointments at baseline (scar management commencement), 1 week post scar management commencement, 3, 6 and 12 months post burn or burn scar reconstruction.
Participants will be provided with face-to-face verbal and written instructions regarding wear and care regimes of their allocated treatment. Participating occupational therapists will complete self-report fidelity checklists for each session and 20% of sessions will be audio recorded to assist with management of fidelity. Participants (and/ or their caregivers) will also complete self-report adherence questionnaires.
Arm 1 = topical silicone gel only. Participants receiving topical silicone gel therapy will be provided with sufficient topical silicone gel to ensure adequate coverage of scars between review appointments. Strataderm topical silicone gel will be applied to the area as directed once/day. Participants (or their caregivers) will be directed to check that the silicone gel is still in contact with the burn scar 8-10 hours later by placing the affected part under running water to check for water beading. If this is not present, participants will be instructed to apply a second application of topical silicone gel (as per manufacturer’s instruction).
Arm 2= pressure garment therapy only. Participants receiving pressure garment therapy will receive 2 sets of pressure garments when commencing scar management which will be replaced as frequently as deemed necessary by the treating occupational therapist. Participants will be instructed to wear their TSL pressure garment for 23hrs/ day. Style, fabric and the use of splinting etc. will be at the Occupational Therapists discretion.
Intervention code [1] 294020 0
Treatment: Other
Comparator / control treatment
Participants in all three arms of the study receive an intervention.
Comparator = Arm 3 = combined topical silicone gel and pressure garment therapy (details of topical silicone gel intervention component as listed under arm 1 and details of pressure garment therapy component as listed under arm 2).
The topical silicone gel is applied first, and when dry (approx 3mins), the pressure garment is donned over the top. After 8-10 hours the pressure garment is removed, topical silicone gel is checked with water beading as above to ensure it is still in contact with the skin. If necessary, a second application of topical silicone gel is applied and when dry the pressure garment is donned over the top as previously described.
Control group
Active

Outcomes
Primary outcome [1] 297470 0
Scar itch
Participant self report on a 0-10 Numeric Rating Scale (NRS)
Toronto Pediatric Itch Scale
Caregiver report using the Patient Observer Scar Assessment Scale (POSAS) NRS
Timepoint [1] 297470 0
Baseline (scar management commencement), 1 week post scar management commencement, 3 months post-burn or post-burn scar reconstruction, 6 months post-burn or post-burn scar reconstruction and 12 months post-burn or post-burn scar reconstruction
Primary outcome [2] 297471 0
Scar thickness
- GE Healthcare Ultrasound
Timepoint [2] 297471 0
Baseline (scar management commencement), 1 week post scar management commencement, 3 months post-burn or post-burn scar reconstruction, 6 months post-burn or post-burn scar reconstruction and 12 months post-burn or post-burn scar reconstruction
Secondary outcome [1] 321143 0
Subjective scar severity (including observer and/or patient opinion of pain, scar pliability, thickness, colour, pigmentation, irregularity, stiffness, and caregiver and therapist overall opinion) - Patient and Observer Scar Assessment Scale (POSAS)
Timepoint [1] 321143 0
Baseline (scar management commencement), 1 week post scar management commencement, 3 months post-burn or post-burn scar reconstruction, 6 months post-burn or post-burn scar reconstruction and 12 months post-burn or post-burn scar reconstruction
Secondary outcome [2] 321144 0
Objective scar colour
- DSMII ColorMeter
Timepoint [2] 321144 0
Baseline (scar management commencement), 1 week post scar management commencement, 3 months post-burn or post-burn scar reconstruction, 6 months post-burn or post-burn scar reconstruction and 12 months post-burn or post-burn scar reconstruction
Secondary outcome [3] 321145 0
Health-related quality of life
- Child Health Utility 9D (CHU-9D)
- Brisbane Burn Scar Impact Profile (BBSIP)
Timepoint [3] 321145 0
Baseline (scar management commencement), 1 week post scar management commencement, 3 months post-burn or post-burn scar reconstruction, 6 months post-burn or post-burn scar reconstruction and 12 months post-burn or post-burn scar reconstruction
Secondary outcome [4] 321146 0
Health service costs
- Recording of costs for the health service e.g. labour time, intervention costs
Timepoint [4] 321146 0
Baseline (scar management commencement), 1 week post scar management commencement, 3 months post-burn or post-burn scar reconstruction, 6 months post-burn or post-burn scar reconstruction and 12 months post-burn or post-burn scar reconstruction
Secondary outcome [5] 324229 0
Adherence
Self report questionnaire by the participant (if eight years or older) or the caregiver (all ages). This questionnaire was designed specifically for this study.
Timepoint [5] 324229 0
Baseline (scar management commencement), 1 week post scar management commencement, 3 months post-burn or post-burn scar reconstruction, 6 months post-burn or post-burn scar reconstruction and 12 months post-burn or post-burn scar reconstruction
Secondary outcome [6] 325743 0
Treatment Satisfaction
- 0-10 Numeric Rating Scale completed by caregivers and therapists
Timepoint [6] 325743 0
Baseline (scar management commencement), 1 week post scar management commencement, 3 months post-burn or post-burn scar reconstruction, 6 months post-burn or post-burn scar reconstruction and 12 months post-burn or post-burn scar reconstruction
Secondary outcome [7] 326309 0
Adverse effects
- Participant or caregiver self report to therapist or trial coordinator, therapist self report to trial coordinator.
Topical silicone gel and pressure garment therapy are considered part of standard care at the participating burns centre, as such, minimal adverse events are expected. Known potential adverse events can include a skin rash from topical silicone gel or skin damage from friction caused by pressure garments. These have a standard management protocol at the participating health service.
Timepoint [7] 326309 0
Baseline (scar management commencement), 1 week post scar management commencement, 3 months post-burn or post-burn scar reconstruction, 6 months post-burn or post-burn scar reconstruction and 12 months post-burn or post-burn scar reconstruction

Eligibility
Key inclusion criteria
Children with a burn injury managed in the acute phase post-burn (up to 16 years of age) or who receive burn scar reconstructive surgery (up to 18 years of age).
Children who require attendance at a scar management clinic after skin healing.
Children who receive skin grafting after a burn injury,
Children with wounds that have not healed by day 17 post-burn.
Children who receive burn scar reconstructive surgery in all body locations.
Children with a TBSA of less than or equal to 40% who are accompanied by a parent or guardian, who is able to provide informed consent.
Children with a cognitive impairment that impedes the ability to communicate will be included, however, will not be required to complete self-report measures. Children and their families who do not speak English will be included but will not be required to complete all self-report measures.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children with comorbidities that might influence scar outcomes (such as a dermatological disorder);
Children involved with the Department of Communities (Child Safety) where the burns consultant and/or burn team members consider study involvement to be contraindicated;
Children with isolated facial or ear burns;
Children with isolated genital burns;
Children who are referred to their local health service before scar management is commenced.

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)
Randomisation concealment will be undertaken by the use of sealed, opaque, identical and serially numbered envelopes prepared by an independent party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Individual randomisation nested in predefined permuted blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Baseline measures will be completed prior to randomisation.
A blinded assessor will assess the primary outcome of scar thickness using images taken by an investigator.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size estimate was calculated based on the primary outcome of scar thickness at six months post-burn. A pooled standard deviation of 1.0mm, a between-group difference of 0.76mm in scar thickness, 80 percent power and an alpha value of 0.017 was assumed.

The primary outcomes will be analysed using regression analyses to examine differences at six and twelve months post-burn. Descriptive, univariate and multivariate analyses (including regression) will be conducted.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/08/2016
Actual
29/08/2016
Date of last participant enrolment
Anticipated
15/08/2017
Actual
27/11/2017
Date of last data collection
Anticipated
15/02/2018
Actual
12/11/2018
Sample size
Target
135
Accrual to date
Final
159
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 5330 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 12792 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 292969 0
Commercial sector/Industry
Name [1] 292969 0
Stratpharma
Country [1] 292969 0
Switzerland
Funding source category [2] 293972 0
University
Name [2] 293972 0
The University of Queensland
Country [2] 293972 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Level 6, 62 Graham Street, South Brisbane, QLD, 4101
Country
Australia
Secondary sponsor category [1] 291741 0
Hospital
Name [1] 291741 0
Lady Cilento Children's Hospital
Address [1] 291741 0
501 Stanley St, South Brisbane QLD 4101
Country [1] 291741 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295387 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 295387 0
Level 7, Centre for Children's Health Research, 62 Graham St, South Brisbane, QLD 4101.
Ethics committee country [1] 295387 0
Australia
Date submitted for ethics approval [1] 295387 0
Approval date [1] 295387 0
18/02/2016
Ethics approval number [1] 295387 0
HREC/15/QRCH/249

Summary
Brief summary
Abnormal scar development following burn injury can cause substantial physical and psychological distress to children and their families. Common burn scar management techniques include silicone therapy, pressure garment therapy, or a combination of both. Currently no definitive high quality evidence is available for the effectiveness, impact on health-related quality of life, health service costs, adherence and treatment satisfaction of topical silicone gel or pressure garment therapy for the prevention and management of burn scars in the paediatric population. Therefore evidence of the effectiveness of these treatments is required in children.
A randomised controlled trial will be conducted. Participants will include 135 children (45 per group) up to 16 years of age who are referred for scar management for a new burn. Children up to 18 years of age will also be recruited following burns scar reconstruction surgery. Participants will be randomised to one of three groups: Strataderm topical silicone gel only, pressure garment therapy only, or combined Strataderm topical silicone gel and pressure garment therapy. Primary outcomes are scar thickness and scar itch intensity. Secondary outcomes include subjective scar severity (e.g. colour, pigmentation, pliability, pain, overall opinion), objective scar colour, health service costs, adherence, health-related quality of life, treatment satisfaction, and adverse effects. Measures will be completed up to 12-months post-burn or post-burn scar reconstruction. Data will be analysed using descriptive, univariate and multivariate statistics including regression analyses.
The results of this study will determine the effectiveness of three non-invasive scar prevention interventions in children at risk of scarring post-burn or post-burn scar reconstruction.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 63762 0
Dr Zephanie Tyack
Address 63762 0
Level 7, Centre for Children's Health Research, 62 Graham St, South Brisbane, QLD 4101.
Country 63762 0
Australia
Phone 63762 0
+61 7 3069 7446
Fax 63762 0
Email 63762 0
[email protected]
Contact person for public queries
Name 63763 0
Jodie Wiseman
Address 63763 0
Level 7, Centre for Children's Health Research, 62 Graham St, South Brisbane, QLD 4101.
Country 63763 0
Australia
Phone 63763 0
+61 7 3069 7385
Fax 63763 0
Email 63763 0
[email protected]
Contact person for scientific queries
Name 63764 0
Jodie Wiseman
Address 63764 0
Level 7, Centre for Children's Health Research, 62 Graham St, South Brisbane, QLD 4101.
Country 63764 0
Australia
Phone 63764 0
+61 7 3069 7385
Fax 63764 0
Email 63764 0
[email protected]

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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
523     Wiseman J, Simons M, Kimble R, Ware R, McPhail S, ... [More Details]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Other filesNo Wiseman J, Simons M, McPhail S, Kimble R, Tyack Z.... [More Details]
Other filesNo Wiseman J, Simons M, McPhail S, Kimble R, Tyack Z.... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffectiveness of topical silicone gel and pressure garment therapy for burn scar prevention and management in children: Study protocol for a randomised controlled trial.2017https://dx.doi.org/10.1186/s13063-017-1820-z
EmbaseCost-effectiveness of scar management post-burn: a trial-based economic evaluation of three intervention models.2022https://dx.doi.org/10.1038/s41598-022-22488-3
N.B. These documents automatically identified may not have been verified by the study sponsor.