Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000044729
Ethics application status
Approved
Date submitted
21/06/2021
Date registered
17/01/2022
Date last updated
17/01/2022
Date data sharing statement initially provided
17/01/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The Use of Negative Pressure Wound Therapy in Paediatric Hand and Feet Burns
Scientific title
The Use of Negative Pressure Wound Therapy in Paediatric Hand and Feet Burns: A pilot, prospective randomised control trial
Secondary ID [1] 306014 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Burn 321722 0
Condition category
Condition code
Injuries and Accidents 319468 319468 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to contrast the use of standard burns dressings (mepitel, acticoat and hypafix- arm 1); with standard dressings AND negative pressure wound therapy (NPWT) (arm 2).

The specific NPWT we will use is the Renasys Touch. This will involve applying the standard dressings; which is what the control group will receive. In addition, the NPWT group will then have Kerlix and hypafix applied over the top. Film or an EasyDress bag will then be applied over this, a hole cut, a soft port applied, the negative pressure canister attached to the port and pressure then delivered.

Children will be randomised to an arm using RedCap, and then burns clinicians (either doctors or burns nurses) will apply the dressings as described. A series of photographs, laser doppler images and ultrasound images will be used to assess the progress of burn epithelialisation. Assessing clinicians will be blinded.

Mixed method questionnaires will be administered throughout the duration of the study to assess the ability to implement this practice - looking at feasibility, acceptability and appropriateness.

Adherence to treatment will be captured by clinic reviews and the feasibility questionnaire. Any patient who fails to attend their appointment will be called to ensure they are not lost to follow up.

Who will deliver the intervention: Burns doctors/Nurses with at least 3 years of clinical experience.
Mode of delivery: Face to face, provided individually
Number of times the intervention will be delivered: NPWT will be applied at the initial time of burn provided nil other treatment has been done; then, it will only be removed between days 5-7 (unless an adverse event occurs, in which case it will be removed, the information around the events logged and standard dressings used). NPWT will not be reapplied after the removal, and the patient will return to standard dressings.

Location where the intervention occurs: Queensland Children's Hospital
Intervention code [1] 320400 0
Treatment: Devices
Comparator / control treatment
Control group: current standard dressings for burns (mepitel, acticoat and hypafix)
- Current standard of care of burns patient at the Queensland Children's Hospital
- Provided by burns clinicians and nurses (at least 3 years experience)
- Always face to face, and application to the hand and feet
- Standard dressings are applied and then changed every 3-5 days, until the burn has completely re-epithelialised
Control group
Active

Outcomes
Primary outcome [1] 327343 0
Feasibility; this will be determined by a feasibility questionnaire distributed when the patients are recruited and at dressing changes. For staff involved with the dressings, a feasibility survey assessing the whole process will also be distributed at the start and end of the study.

This questionnaire was designed specifically for this trial, and based off a paper titled 'Psychometric assessment of three newly developed implementation outcome measures' which gives a framework for appropriate questions in qualitative research.
Timepoint [1] 327343 0
At commencement of the study, recruitment, removal of NPWT and completion of study
Primary outcome [2] 328489 0
Safety; any adverse outcomes will be recorded in a safety data base '

Adverse outcomes will be captured by both clinicians and participants in one of two ways - either at their clinic appointment or in the surveys they have to complete. The survey has been specifically designed for this study and will ask at the time the negative pressure wound therapy comes off if there were any adverse events

Adverse outcomes include: pain, itching, unable to achieve a seal with the negative pressure wound therapy
Timepoint [2] 328489 0
Duration of NPWT application
The outcome will be assessed at their next clinic appointment - which will be when we are removing the NPWT and approximately 4-7 days after initial application (as per protocol).
Secondary outcome [1] 394659 0
Time to re-epithelialisation - clinical photographs with burns clinicians then doing a blinded review of photographs to assess epithelialisation. The burn will be considered healed at 95% epithelialisation.
Timepoint [1] 394659 0
Re-epithelialisation - within acute period of burn treatment at all dressing changes
Secondary outcome [2] 399169 0
Pain

This will be assessed at home (between dressings via parents)

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);
Timepoint [2] 399169 0
All dressing changes (parents will complete the survey to explain what they have observed at home in between dressing changes) and 3 months post commencement of intervention
Secondary outcome [3] 399170 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 [3] 399170 0
All dressing changes and 3 months post-commencement of intervention
Secondary outcome [4] 399171 0
Scar - ultrasound scan to measure the thickness of the scar, three measurements will be recorded and then the median of these measurements used.
Timepoint [4] 399171 0
3 months post commencement of intervention
Secondary outcome [5] 399172 0
Range of motion - via OT review (where a combination of visual assessment and goniometer measurements will be used) and the Brisbane Burn Scar Impact profile
Timepoint [5] 399172 0
3 months post-commencement of intervention
Secondary outcome [6] 399173 0
Health related quality of life specific to people with burns scar - Brisbane Burn scar impact profile
Timepoint [6] 399173 0
3 months post-commencement of intervention
Secondary outcome [7] 404075 0
Pain

This will be assessed during dressing changes (in clinic via clinicians).

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 [7] 404075 0
All dressing changes and 3 months post-commencement of intervention

Eligibility
Key inclusion criteria
1. Age less than or equal to 16 years of age
2. Must present within 24hours of sustaining a burn injury
3. Any burn that is deep partial thickness or of greater depth on the hand or foot
4. >0.5% TBSA on one hand or foot (ie >1/2 of the hand or foot) and is SPT
5. May be in the context of a larger burn
Minimum age
No limit
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Clinician treatment priority contradicts randomization
2. Do not wish to participate
3. The child is unwell at the time of presentation

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
RedCap Software

A randomisation table will be created in excel and then uploaded to the redcap database to allow randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
As this is a feasibility pilot study, we predict 30 participants will be sufficient to determine safety and acceptability of the proposed intervention and outcome measures. Brickett and Day 1994 suggest that a pilot sample of approximately 10 are sufficient to perform a pilot study.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/02/2022
Actual
Date of last participant enrolment
Anticipated
16/06/2022
Actual
Date of last data collection
Anticipated
3/10/2022
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19218 0
Queensland Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 33791 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 308455 0
Hospital
Name [1] 308455 0
Queensland Children's Hospital
Country [1] 308455 0
Australia
Primary sponsor type
Hospital
Name
Queensland Children's Hospital
Address
501 Stanley Street
South Brisbane
Queensland
Australia
4101
Country
Australia
Secondary sponsor category [1] 309292 0
None
Name [1] 309292 0
Address [1] 309292 0
Country [1] 309292 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308410 0
The Children's Health Queensland Human Research Ethics Committee
Ethics committee address [1] 308410 0
Ethics committee country [1] 308410 0
Australia
Date submitted for ethics approval [1] 308410 0
27/04/2021
Approval date [1] 308410 0
13/05/2021
Ethics approval number [1] 308410 0
HREC/21/QCHQ/75637

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

Contacts
Principal investigator
Name 110618 0
Dr Emma Lumsden
Address 110618 0
Queensland Children's Hospital
Paediatric Surgery Department
501 Stanley Street
South Brisbane
Queensland
4101
Country 110618 0
Australia
Phone 110618 0
+61 448345137
Fax 110618 0
Email 110618 0
[email protected]
Contact person for public queries
Name 110619 0
Emma Lumsden
Address 110619 0
Queensland Children's Hospital
Paediatric Surgery Department
501 Stanley Street
South Brisbane
Queensland
4101
Country 110619 0
Australia
Phone 110619 0
+61 448345137
Fax 110619 0
Email 110619 0
[email protected]
Contact person for scientific queries
Name 110620 0
Emma Lumsden
Address 110620 0
Queensland Children's Hospital
Paediatric Surgery Department
501 Stanley Street
South Brisbane
Queensland
4101
Country 110620 0
Australia
Phone 110620 0
+61 448345137
Fax 110620 0
Email 110620 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?
De-identified data will be shared in a line by line format, available upon request and this will include all of the individual participant data collected during the trial
When will data be available (start and end dates)?
From the start of the trial to up to 15 years post (as in keeping with how long data will be stored).
Available to whom?
Researchers, clinicians and public who have written an email and letter stating the reason they want the data
Available for what types of analyses?
For meta-analysis
How or where can data be obtained?
By email communication with myself ([email protected]), then using a research data sharing platform such as research data space.


What supporting documents are/will be available?




Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial.2023https://dx.doi.org/10.1186/s40814-023-01308-z
N.B. These documents automatically identified may not have been verified by the study sponsor.