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Trial registered on ANZCTR

Registration number

ACTRN12617001274369

Ethics application status

Approved

Date submitted

11/08/2017

Date registered

5/09/2017

Date last updated

29/10/2021

Date data sharing statement initially provided

17/05/2019

Date results provided

29/10/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Effectiveness of a Topical Application in Reducing Pain in Children Within the Early Management of the Acute Paediatric Burn; a Randomised Controlled Trial.

Scientific title

Effectiveness of a Burnaid® hydrogel dressing in Reducing Pain in Children Within the Early Management of the Acute Paediatric Burn; a Randomised Controlled Trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Burn

Pain

Condition category

Condition code

Injuries and Accidents

Burns

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Burnaid® hydrogel dressing will be the chosen intervention that the child will receive based on randomisation on presentation to the Department of Emergency Medicine (DEM) or burns Outpatients Department (OPD). Burnaid® is a sterile open foamed polyester urethane foam that is impregnated with 90% purified water. The dressing has gained widespread use by paramedics in recent years in the treatment of acute burn pain.
In this study the Burnaid® dressing will be applied post 20 minutes Cold Running Water (CRW) and will remain on the burn for a minimum of 20 minutes. Burnaid® will be applied as per the manufactures instructions followed by standard burn care. The 20 min time period of Burnaid® hydrogel dressing has been selected in the acute phase of the burn where pain is still present after the 20 min of CRW has been completed. D
After the Burnaid® has been removed, a standard, protocol informed, silver dressing will be applied. The silver dressing will remain intact until the patient is due to return to Burns OPD 3-7 days post injury. The silver dressing will be changed twice weekly, in the Burn OPD until the wound is 95% re-epithelialised as per the treating clinician. Any adverse events or concerns with patient activity (swimming with dressing, playing in a sandpit) will be documented.

Intervention code [1]

Treatment: Other

Comparator / control treatment

The current standard of care following burns first aid (20 mins of CRW) is laying plastic wrap over the burn, aiming to decrease exposure of skin to the air to decrease the acute burn pain. This plastic wrap is left intact until the patient has had adequate pain relief to adequately debride residual blisters and clean the burn. After the cleaning process, a silver dressing is selected as per hospital protocol and applied to the burn. This silver dressing stays in tact until the standard follow up appointment in Burns OPD.

Control group

Active

Outcomes

Primary outcome [1]

Composite Pain intensity will be assessed prior, during, and post application of the Burnaid or plastic wrap using three age specific scales, allowing assessment of pain and distress;
1) child self-report using the Faces Pain Scale – Revised (FPS-R) for children ages 3 years and older;
2) Faces, Legs, Activity, Cry, and Consolability Scale (FLACC) for parents/guardians and nursing staff.
3) Visual Analogue Scale for Pain (VAS-P) for children aged 8 years and older and observer VAS (VASobs) for parent/guardian reports.

Timepoint [1]

Pain scores will be measured during the acute phase of the burn. FLACC, VAS and FPS-R will all be taken at three main time points
1. Post CRW /Pre Burnaid or plastic wrap application
2. During Burnaid or plastic wrap application
3. Post removal of the Burnaid or plastic wrap

Secondary outcome [1]

Time to re-epithelialisation assessed in two ways.
- Clinical judgement by surgeon treating the patient
- Blinded second assessment from digital photographs

Timepoint [1]

up to 14 days

Secondary outcome [2]

Composite assessment of Ease of dressing application. Assessment will include
- flexibility and conformity using a NRS
- Patient/parent perception – comfort, ease of movement and ease of dressing removal using
- Numeric Rating Scale - nursing assessment ease of application, care, and removal

Timepoint [2]

Immediately after the Burnaid or plastic wrap application.

Secondary outcome [3]

Composite Dressing costs. Assessment will include:
- Nursing time for dressing changes
- Cost of dressings
- Medication costs associated with dressings (analgesia) all as per current clinical standards

Timepoint [3]

Time for dressing change will be measured in emergency and at each dressing change.
Medication and dressing costs will be totalled once donor site wound has re-epithelialised

Secondary outcome [4]

Composite Scar maturation

Cosmetic appearance of burn by POSAS (Pt and Observor Scar Assessment Scale)
3D camera (for depth/height, and colour)
Ultrasound (for thickness of scar tissue)
BBSIP (Scar impact)

Timepoint [4]

3 and 6 months post injury

Secondary outcome [5]

Composite Itch Measure:
1.Toronto Paediatric Itch Scale (TPIS) will be used to assess pruritus in patients aged less than 5 years.
2.Parents/caregivers of patients aged less than 5 years will complete the TPIS, which rates itch behaviours on a scale of 0 (indicating absence of itch) to 3 (which represents severe itch with significant disruption).
3. Participants aged 5 years and older will self-report their itch intensity using a 0 – 10 NRS. 4.All caregivers will also complete the itch component of the POSAS, which is a 0 -10 NRS

Timepoint [5]

Itch will be assessed at the first Change of Dressing (COD) in burns clinic and each follow up Burns OPD appointment until the wound is deemed re-epithelised, and will also be assessed at the 3 and 6 month reviews.
Follow up appointments are determined and set by the treating clinical team. They are based on a clinical judgement of time critical point of predicted wound healing and dressing requirements.
The 3 and 6 month appointments will be set by the research team to determine the influence of itch as the wound / scar heals or matures.

Secondary outcome [6]

Health related quality of life- Child Health Utility 9D (CHU9D)
Children 7 and above will self-complete the CHU9D instrument (where age appropriate) and a parent/caregiver self-report will be completed for children of all ages

Timepoint [6]

3 and 6 month follow ups.

Secondary outcome [7]

salivary a-amylase ratio

Timepoint [7]

1) at first presentation to the DEM or Burns OPD subsequent to the application of either Burnaid® hydrogel dressings or plastic wrap, 2) immediately after the removal of the Burnaid® or plastic wrap dressing, 3) before application of silver dressings, 4) immediately after the application of silver dressings, 5) immediately before premedication prior to the patient’s first COD, 6) immediately after the application of the new dressings, and 7) three months post-burn injury

Secondary outcome [8]

Composite Physical measures of pain and distress. Including:
1. pulse rate monitoring at 2 minute intervals,
2.respiratory rate, and
3. temperature

Timepoint [8]

In the acute phase of the burn:
1. Post CRW /Pre Burnaid or plastic wrap application
2. During Burnaid or plastic wrap application
3. Post removal of the Burnaid or plastic wrap
and for subsequent silver dressing changes in Burns OPD
1. Pre dressing change
2. During dressing change (peak pain)
3. Post dressing change

Secondary outcome [9]

analgesia medication requirements
1. Completing the participant case report form (including type and dose of analgesia used in Emergency and Outpatient visits).
2. Parent home diary (documenting analgesia requirements,type, dose, frequency) at home,

Timepoint [9]

1. At the acute phase in DEM during the dressing application
2. At home between dressing changes
2. Subsequent dressing changes

Secondary outcome [10]

Salivary Cortisol

Timepoint [10]

Secondary outcome [11]

Distractions used (iphone, DVD, clown doctors, Ditto device etc)

Timepoint [11]

1. At the acute phase in DEM during the dressing application and
2. Subsequent dressing changes

Eligibility

Key inclusion criteria

Children recruited into the study will age between 0 – 16 years that have acquired an acute thermal burn injury that is below 20% of the Total Body Surface Area (TBSA). The child must present to the emergency department or burns outpatient department within 24 hours of sustaining the injury, and have no silver dressing application prior to this admission.

Minimum age

0 Years

Maximum age

16 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Children outside of the age group will be excluded from the study along with if their mechanism is on e of the following causes; chemical, electrical, inhalation, or friction; children who do not arrive within 24 hours of sustaining their acute burn injury; children who received prior treatment of a silver dressing; are non English speaking; children with cognitive impairments; ventilated or require initial wound care in theatre for debridement or grafting; current involvement with the Department of Communities (child safety); have co-morbidities that would potentially impair would healing (e.g. diabetes) or that may exacerbate itch and pain. Apart from which type of dressing the child is receiving prior to the application of silver, all participants will receive the standard medical care as would those not in the trial.

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)

Sequentially numbered, sealed, opaque envelopes

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

computerised sequence generation

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Pain is the primary outcome with a 5% significance level and a power of 80%, 29 patients per group required. Allowing for 10% drop-out gives 72 patients in total.
Descriptive statistics will be calculated for all outcomes. Univariate parametric analyses or alternative non-parametric equivalent tests will be utilised to assess differences between groups where appropriate (e.g., t-tests, Chi-square, Mann Whitney U test). Regression models that account for randomly missing data and clustering of wound sites (where appropriate) within patients will be utilised to analyse differences in pain and wound healing between the groups and over time, as well as to analyse factors predicting the primary outcomes. Intention to treat analysis will be used. Significance will be set at p < 0.05. Post-hoc adjustment for multiple comparisons will be conducted using the Sidak correction. A statistician will be contracted to be involved in data analysis.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

6/09/2017

Actual

13/09/2017

Date of last participant enrolment

Anticipated

22/08/2018

Actual

14/09/2018

Date of last data collection

Anticipated

21/02/2019

Actual

14/03/2019

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

QLD

Recruitment hospital [1]

Lady Cilento Children's Hospital - South Brisbane

Recruitment postcode(s) [1]

4101 - South Brisbane

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Mundipharma

Address [1]

GPO Box 5214,
Sydney, NSW, 2001
Australia

Country [1]

Australia

Primary sponsor type

Hospital

Name

Lady Cilento Children's Hospital

Address

Pegg Leditscke Children's Burns Centre
South Brisbane
QLD, 4101

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 Human Research Ethics Committee

Ethics committee address [1]

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

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

16/08/2016

Approval date [1]

13/09/2016

Ethics approval number [1]

HREC/16/QRCH/322

Ethics committee name [2]

Site Specific Assessment Children's Health Queensland

Ethics committee address [2]

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

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

29/08/2016

Approval date [2]

13/09/2016

Ethics approval number [2]

SSA/16/QRCH/402

Summary

Brief summary

1. Background
Burns are a painful and traumatic experience. Literature has found that using pharmacological and non-pharmacological interventions aid in providing appropriate pain management and significantly improve paediatric burn outcomes. Overall, there seems to be some evidence that reduced pain and anxiety positively influences re-epithelialisation rates however current literature fails to fully explain the effects of pain and anxiety and their links with wound healing. This study will determine if Burnaid® is an effective treatment for reducing pain in the acute period of a burn injury. It is hypothesised that a reduction in pain, as well as stress/anxiety, will then improve re-epithelialisation time in comparison to plastic wrap which is standard practice at our institute, a large metropolitan paediatric hospital located in Brisbane, Australia.   
1.2	Methods/Design
A randomised controlled trial will be conducted assessing the effectiveness of Burnaid® hydrogel dressings as an analgesic adjunct to cold running water (CRW) first aid for the treatment of paediatric burns. Participants will include children aged between 0 – 16 years with an acute thermal burn injury with a total burn surface area (TBSA) of < 20% admitted to our emergency within 24hours of the burn occurring. Participants will be stratified into one of two groups based on factors which increase pain intensity. The trial will then randomise patients into one of two groups: 1) Plastic wrap which will serve as the control arm or 2) Burnaid® which is the intervention arm. The trial requires a minimum of 29 participants per group, which will be assessed from day of injury to re-epithelialisation. The primary outcome of the trial is the effect of the intervention on reducing acute pain. Secondary outcomes include: days to re-epithelialisation, Physiological changes that indicate pain intensity (pulse rate, temperature and respiratory rate), analgesia and distraction techniques required, , cost effectiveness, staff perspectives on the treatmen, Health related Quality of Life (Child Health Utility 9D - CHU9D) and salivary cortisol and a-amylase ratio (informing influences of stress and anxiety)
1.3	Discussion
This study will provide comprehensive data on the analgesic properties of Burnaid® hydrogel dressings as an adjunct to CRW first aid for the treatment of acute paediatric thermal burns. If the intervention shows to be effective in reducing acute pain, Burnaid® dressings will be integrated as standard care practices at our institute. This study replicates a real-world scenario in order to identify clinically significant analgesic and would healing effects.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Ms Maleea Holbert

Address

Centre for Children's Health Research
Centre for Children's Burns and Trauma Research,
Level 7, 62 Graham St
South Brisbane
QLD, 4101

Country

Australia

Phone

+61 422247359

Fax

m.holbert@uq.edu.au

Contact person for public queries

Name

Bronwyn Griffin

Address

Centre for Children's Health Research
Centre for Children's Burns and Trauma Research,
Level 7, 62 Graham St
South Brisbane
QLD, 4101

Country

Australia

Phone

+61 404892517

Fax

b.griffin@uq.edu.au

Contact person for scientific queries

Name

Maleea Holbert

Address

Centre for Children's Health Research
Centre for Children's Burns and Trauma Research,
Level 7, 62 Graham St
South Brisbane
QLD, 4101

Country

Australia

Phone

+61 422247359

Fax

m.holbert@uq.edu.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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	Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric thermal burn injuries: Study protocol for a randomised controlled trial.	2019	https://dx.doi.org/10.1186/s13063-018-3057-x
Embase	Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: A prospective randomised controlled trial.	2021	https://dx.doi.org/10.1136/bmjopen-2020-039981

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

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