ANZCTR - Registration

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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]

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

Condition category

Condition code

Surgery

Other surgery

Injuries and Accidents

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]

Treatment: Devices

Comparator / control treatment

The Control Group will receive standard dressings: mepitel and acticoat

Control group

Active

Outcomes

Primary outcome [1]

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]

Commencement of trial, recruitment, dressing changes and end of trial

Primary outcome [2]

Patient Safety - An adverse log will be set up so that each time one occurs, it can be entered

Timepoint [2]

At any point throughout the trial while the PICO dressing is applied (ie first 3-5 days of burn management)

Secondary outcome [1]

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]

At each dressing change and 3 month follow up post commencement of intervention

Secondary outcome [2]

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]

At each dressing change

Secondary outcome [3]

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]

At each presentation to the clinic/dressing change

Secondary outcome [4]

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]

3 month follow up post commencement of intervention

Secondary outcome [5]

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]

All dressing changes and also 3 month follow up post commencement of intervention

Secondary outcome [6]

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]

3 month follow up post commencement of intervention

Secondary outcome [7]

Range of motion - assessed by occupational therapist (using goniometer and visual assessment)

Timepoint [7]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Queensland Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Smith and Nephew

Address [1]

Smith & Nephew Wound Management
PO Box 81
101 Hessle Road
HULL
HU3 2BN
UK

Country [1]

United Kingdom

Primary sponsor type

University

Name

Griffith University

Address

170 Kessels Rd, Nathan Campus, Nathan, Queensland, 4111

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Children's Health Queensland HREC

Ethics committee address [1]

Level 7 Centre for Children's Health Research,
64 Graham St, 
South Brisbane, QLD, 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

07/12/2020

Approval date [1]

01/02/2021

Ethics approval number [1]

HREC/20/QCHQ/67220

Summary

Brief summary

Burn wound progression can be variable after the initial injury has occurred. Tissue oedema as a result of the injury can compromise microcirculation resulting in this progression. Pressure applied to this area through NPWT is known to squeeze oedema fluid out of the interstitial space. It is plausible that applying NPWT within this initial timeframe may halt or limit burn wound progression.

The use of Negative Pressure Wound therapy (NPWT) in the treatment of burns has increased over the past decade. It is common practice at the Pegg Leditschke Children’s Burns Centre, Queensland Children’s Hospital to apply NPWT post-split thickness graft to improve take of the graft and more recently it’s efficacy in acute burns has been tested using the Renasys Go. More recently the Renasys Go has been trialled in the unit for burns less than 5% TBSA within 1 week of injury. This study found improved clinical outcomes, especially when applied within 48 hours. However, parents reported a burden due to the size of the Renasys Go and need for recharging accessories. There is lack of information regarding the use of the smaller, battery operated NPWT device, PICO, as a primary treatment for acute burns. 

Applying NPWT could greatly improve the final outcome of a burn wound. This could have multiple implications as improved time to re-epithelialisation can impact on overall cost of treatment, requirements for scar management as well as possible reconstructive requirement in the future.
This study will address the paucity of knowledge of “ultra portable” negative pressure devices for use in acute burn wound care. This will build on knowledge recently acquired in a randomised controlled with a larger device (Smith and Nephew – Renasys Go). 
This study aims to establish the feasibility and safety for the use of the ultra-portable PICO negative pressure device in children with burn injuries.

Trial website

NA

Trial related presentations / publications

Public notes

NA

Contacts

Principal investigator

Name

Dr Bronwyn Griffin

Address

Centre for Children's Health Research
62 Graham Street
South Brisbane , Queensland
4101

Country

Australia

Phone

+61 404892517

Fax

bronwyn.griffin@griffith.edu.au

Contact person for public queries

Name

Bronwyn Griffin

Address

Centre for Children's Health Research
62 Graham Street
South Brisbane, Queensland
4101

Country

Australia

Phone

+61 404892517

Fax

bronwyn.griffin@griffith.edu.au

Contact person for scientific queries

Name

Bronwyn Griffin

Address

Centre for Children's Health Research
62 Graham Street
South Brisbane, Queensland
4101

Country

Australia

Phone

+61 404892517

Fax

bronwyn.griffin@griffith.edu.au

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 (bronwyn.griffin@griffith.edu.au)

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

Source	Title	Year of Publication	DOI
Embase	Protocol for a feasibility, acceptability and safety study of the PICO device (negative pressure wound therapy) in acute paediatric burns.	2023	https://dx.doi.org/10.1136/bmjopen-2022-068499

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically