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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Burn

Condition category

Condition code

Injuries and Accidents

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]

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]

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]

At commencement of the study, recruitment, removal of NPWT and completion of study

Primary outcome [2]

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]

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]

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]

Re-epithelialisation - within acute period of burn treatment at all dressing changes

Secondary outcome [2]

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]

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]

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]

All dressing changes and 3 months post-commencement of intervention

Secondary outcome [4]

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]

3 months post commencement of intervention

Secondary outcome [5]

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]

3 months post-commencement of intervention

Secondary outcome [6]

Health related quality of life specific to people with burns scar - Brisbane Burn scar impact profile

Timepoint [6]

3 months post-commencement of intervention

Secondary outcome [7]

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]

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?

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

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]

Hospital

Name [1]

Queensland Children's Hospital

Address [1]

501 Stanley Street
South Brisbane
Queensland
Australia
4101

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Children's Health Queensland Human Research Ethics Committee

Ethics committee address [1]

Human Research Ethics Committee
Centre for Children’s Health Research
Queensland Children’s Hospital Precinct
Level 7, 62 Graham Street
South Brisbane QLD 4101

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/04/2021

Approval date [1]

13/05/2021

Ethics approval number [1]

HREC/21/QCHQ/75637

Summary

Brief summary

Paediatric Hand and Feet burns are a challenging injury for burns clinicians. They have a high prevalence and rate of ongoing morbidity. This is due to a combination of factors including children being curious about their environment and exploring with their hands, having slow withdrawal reflexes and hands and feet having multiple joints within a small body surface area. We believe the management of these burns could be further improved to try and reduce the ongoing morbidity. Currently, standard dressings (mepitel, acticoat and hypafix) are used to dress these burns but there is evidence to suggest that including Negative Pressure Wound Therapy as well may reduce the time to healing and therefore the ongoing morbidity. To include negative pressure as a standard practice of treatment, it must first be shown that it is both feasible and safe. 

Hypothesis: That the use of NPWT is both feasible and safe in paediatric hand and feet burns.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Emma Lumsden

Address

Queensland Children's Hospital
Paediatric Surgery Department
501 Stanley Street
South Brisbane
Queensland
4101

Country

Australia

Phone

+61 448345137

Fax

emma.lumsden@health.qld.gov.au

Contact person for public queries

Name

Emma Lumsden

Address

Queensland Children's Hospital
Paediatric Surgery Department
501 Stanley Street
South Brisbane
Queensland
4101

Country

Australia

Phone

+61 448345137

Fax

emma.lumsden@health.qld.gov.au

Contact person for scientific queries

Name

Emma Lumsden

Address

Queensland Children's Hospital
Paediatric Surgery Department
501 Stanley Street
South Brisbane
Queensland
4101

Country

Australia

Phone

+61 448345137

Fax

emma.lumsden@health.qld.gov.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?

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 (emma.lumsden@griffithuni.edu.au), then using a research data sharing platform such as research data space.

What supporting documents are/will be available?

Type	Email	Attachment
Study protocol	emma.lumsden@health.qld.gov.au	381890-(Uploaded-10-12-2021-14-50-04)-Study-related document.docx
Informed consent form	emma.lumsden@health.qld.gov.au	381890-(Uploaded-10-12-2021-14-50-28)-Study-related document.docx
Ethical approval	emma.lumsden@health.qld.gov.au	381890-(Uploaded-03-08-2021-13-12-29)-Study-related document.pdf

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	The feasibility of negative pressure wound therapy versus standard dressings in paediatric hand and foot burns protocol: a pilot, single-centre, randomised control trial.	2023	https://dx.doi.org/10.1186/s40814-023-01308-z

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

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