Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000009718
Ethics application status
Approved
Date submitted
11/02/2021
Date registered
11/01/2022
Date last updated
11/01/2022
Date data sharing statement initially provided
11/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A feasibility and safety study of an ultra-portable negative pressure wound therapy device in acute paediatric burns on pain, re-epithelialisation and injury progression.
Scientific title
A feasibility and safety study of an ultra-portable negative pressure wound therapy device in acute paediatric burns (neonates to 16 years) on pain, re-epithelialisation and injury progression.
Secondary ID [1] 303424 0
Nil
Universal Trial Number (UTN)
Trial acronym
PICO PILOT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burns in paediatric patients 320719 0
Condition category
Condition code
Surgery 318563 318563 0 0
Other surgery
Injuries and Accidents 318564 318564 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a three arm study, with one arm being the control group and then two being interventions.

Intervention one – standard dressing (mepitel, acticoat) with the PICO dressing
Intervention two – mepitel, acticoat flex with the PICO dressing

Which intervention a patient is allocated to will depend on which group they are randomised to via redcap.

The patient would usually receive mepitel and acticoat with hypafix on a standard burn. In intervention one, mepitel and acticoat will be applied but then a PICO dressing will be applied over the top. This device applies NPWT at -80mmHg.

Intervention two is very similar to intervention one. However, we will use acticoat instead of acticoat flex. The reason for inclusion of this branch is it may sit better underneath the PICO dressing than the pure acticoat.

The PICO will be turned on once applied and then left on delivering pressure at -80mmHg continuously for 3-5 days. The PICO dressing will be removed at the first dressing change, and then the dressings will return to standard dressings.

The PICO dressings will be applied by experienced burns clinicians – including burns surgeons and nurses. Each of these people will have had a minimum of three years clinical experience. These dressings will be applied face to face.

The intervention location will be the Queensland Children’s Hospital.

Adherence will be assessed by review at outpatient clinic. If the patient does not attend clinic, we will call the patient/family multiple times to ensure they are not lost to follow up.

Intervention code [1] 319729 0
Treatment: Devices
Comparator / control treatment
The Control Group will receive standard dressings: mepitel and acticoat
Control group
Active

Outcomes
Primary outcome [1] 326520 0
Feasibility - will be assessed by a questionnaire given to patients at recruitment and dressing changes and then for clinicians involved in the process both at the start and end of the trial.
Timepoint [1] 326520 0
Commencement of trial, recruitment, dressing changes and end of trial
Primary outcome [2] 326521 0
Patient Safety - An adverse log will be set up so that each time one occurs, it can be entered
Timepoint [2] 326521 0
At any point throughout the trial while the PICO dressing is applied (ie first 3-5 days of burn management)
Secondary outcome [1] 391767 0
Pain - this will be a composite measure of the below parameters and will be assessed during dressing changes

Parents
1. Participants self report of pain intensity using the Faces Pain Scale Revised (FPS-R) (if participant was aged 3 years or over);
2. Participant’s self report (if aged over 8 years) or the parents report of the participant’s pain intensity using a Visual Analogue Scale – Pain (VAS-P);

Clinicians
1. Nurses’ observational rating of the participant’s pain and distress using the face, legs, activity, cry, consolability (FLACC) scale (<3 years old);
2. Any analgesic and/or sedative medications administered to the participant at each dressing change will be also recorded
Timepoint [1] 391767 0
At each dressing change and 3 month follow up post commencement of intervention
Secondary outcome [2] 391768 0
Percentage re-epithelialisation

Photos of the wound will be taken at each dressing change, then clinicians will be blinded and asked to confirm when they think are 95% epithelialised
Timepoint [2] 391768 0
At each dressing change
Secondary outcome [3] 391777 0
Resource use and costs will be recorded for each participant from the perspective of the health service provider and costed at market rates

This will include trial interventions costs (e.g. the number of dressing changes, type and size of dressings used and scar therapy products), as well as other burn-related resource use (and costs) that may be important to a health service deciding which of the interventions to implement in their model of care for patients with burns (e.g. moulds and splinting, overheads and labour time). Labour time (e.g. occupational therapists, physiotherapist, nurses and surgeons) will be quantified for each patient (on the basis of time duration utilised and number of appointments required) and costed at the relevant state award rates for each respective discipline. Length of stay in hospital will be calculated up until the time that the patient is clinically ready for discharge, omitting any additional occasions of social admission needs.
Timepoint [3] 391777 0
At each presentation to the clinic/dressing change
Secondary outcome [4] 391778 0
Scar assessment

- Ultrasound Scan (BT12 Venue 40 MSK, GE Healthcare) will be taken of the burn area to measure the thickness of the scar. 3 measurements will be taken and then the median of these measurements will be used
Timepoint [4] 391778 0
3 month follow up post commencement of intervention
Secondary outcome [5] 391779 0
Itch

Itch intensity will be self-reported for children aged 8 years and older using an 11-point NRS (0 to 10). The Toronto Pediatric Itch Scale is an observation based scale rating itch behaviours on a scale of 0 (absence of itch) to 4 (severe itch with significant disruption) and will be completed by caregivers for children aged under 5 years. Between the ages of 5 and 8, the Itch Man Scale will be used which asks patients to identify which picture on a 5 point scale (0 – 4) best represents their itch. Numeric rating scales have been recommended over visual analogue scales due to improved adherence, increased responsiveness and fewer missing values in populations of adults with pain and chronic itch.
Timepoint [5] 391779 0
All dressing changes and also 3 month follow up post commencement of intervention
Secondary outcome [6] 391780 0
Quality of life


The Brisbane Burn Scar Impact Profile will be used to measure the intensity and frequency of sensations, such as pain, tightness and discomfort as well as health related quality of life specific to people with burn scars. This measure was developed and tested for preliminary validity in children with burn scars and is undergoing further testing with children and caregivers. In adults with burn scars the Brisbane Burn Scar Impact Profile has been found to have acceptable reproducibility, responsiveness and longitudinal validity
Timepoint [6] 391780 0
3 month follow up post commencement of intervention
Secondary outcome [7] 391781 0
Range of motion - assessed by occupational therapist (using goniometer and visual assessment)
Timepoint [7] 391781 0
3 month follow up post commencement of intervention

Eligibility
Key inclusion criteria

1. Age less than or equal to 16 years of age
2. Must present within 48hours of sustaining a burn injury
3. All burn depths
4. All mechanisms (excluding electrocution)
5. Burn wound must be contained within the size of the available PICO dressings
6. Flat surfaces
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Older than 16yrs of age
2. Burns located on face, fingers, toes, elbows, knees, or other non flat surfaces
3. The area of burn can not be contained within the standard PICO dressings sizes
4. Clinician treatment priority contradicts randomisation

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 through randomisation service (computer)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis
Baseline characteristics will be assessed using descriptive statistics. The clinical exploratory outcomes will be analysed according to the principle of an intention-to-treat approach. Pain will be analysed with multilevel generalized linear mixed effects modelling with a log link function and gamma distribution to determine differences between the treatment groups at timepoints and over time. We will analyse data using logistic regression for dichotomous outcomes and linear regression for continuous outcomes. Due to the nature of the intervention, a blinding of participants and therapists is not possible. Blinded outcome assessment will be performed via de-identified photographs of the wounds and deidentified data.. Statistical analyses will be performed by a blinded statistician presenting an independent report. .

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2022
Actual
Date of last participant enrolment
Anticipated
1/07/2022
Actual
Date of last data collection
Anticipated
29/11/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 18711 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 33152 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 307844 0
Commercial sector/Industry
Name [1] 307844 0
Smith and Nephew
Country [1] 307844 0
United Kingdom
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Rd, Nathan Campus, Nathan, Queensland, 4111
Country
Australia
Secondary sponsor category [1] 308552 0
None
Name [1] 308552 0
NA
Address [1] 308552 0
NA
Country [1] 308552 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307842 0
Children's Health Queensland HREC
Ethics committee address [1] 307842 0
Ethics committee country [1] 307842 0
Australia
Date submitted for ethics approval [1] 307842 0
07/12/2020
Approval date [1] 307842 0
01/02/2021
Ethics approval number [1] 307842 0
HREC/20/QCHQ/67220

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

Contacts
Principal investigator
Name 108698 0
Dr Bronwyn Griffin
Address 108698 0
Centre for Children's Health Research
62 Graham Street
South Brisbane , Queensland
4101
Country 108698 0
Australia
Phone 108698 0
+61 404892517
Fax 108698 0
Email 108698 0
[email protected]
Contact person for public queries
Name 108699 0
Bronwyn Griffin
Address 108699 0
Centre for Children's Health Research
62 Graham Street
South Brisbane, Queensland
4101
Country 108699 0
Australia
Phone 108699 0
+61 404892517
Fax 108699 0
Email 108699 0
[email protected]
Contact person for scientific queries
Name 108700 0
Bronwyn Griffin
Address 108700 0
Centre for Children's Health Research
62 Graham Street
South Brisbane, Queensland
4101
Country 108700 0
Australia
Phone 108700 0
+61 404892517
Fax 108700 0
Email 108700 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Basic demographic (non-identifying), burn injury characteristics, feasibility and safety outcomes, clinical outcomes.
When will data be available (start and end dates)?
June 2022 - Jun2025
Available to whom?
General public upon applicatiomn
Available for what types of analyses?
aggregate or systematic literature reviews for meta-analysis.
How or where can data be obtained?
Access subject to approval by PI via email ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProtocol for a feasibility, acceptability and safety study of the PICO device (negative pressure wound therapy) in acute paediatric burns.2023https://dx.doi.org/10.1136/bmjopen-2022-068499
N.B. These documents automatically identified may not have been verified by the study sponsor.