Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000126617
Ethics application status
Approved
Date submitted
12/01/2023
Date registered
7/02/2023
Date last updated
9/02/2023
Date data sharing statement initially provided
7/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of coconut oil on healing of childhood burns
Scientific title
Comparing the effect of topical coconut oil and standard of care on wound healing outcomes in newly healed burns and skin graft donor sites in paediatric burn patients - a pilot randomised controlled trial
Secondary ID [1] 308745 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
burns 328687 0
Condition category
Condition code
Injuries and Accidents 325697 325697 0 0
Burns
Skin 325887 325887 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is of topical coconut oil application to all areas where moisturiser (sorbelene) is usually applied, twice daily for 12 weeks. These will include conservatively managed wounds, surgically treated burns sounds, donor wound sites.

-The investigational product is 100% certified organic, virgin coconut oil manufactured and supplied by Nature Pacific Pty Ltd, Varsity Lakes, Qld. This coconut oil is readily available for purchase in Australia under the trade name Tutu Virgin Coconut Oil.
-Each batch of coconut oil is independently assessed and is free of any contamination, additives or derivatives.
- Independently tested by NATA and AQUIS accredited institution Symbio laboratories (44 -52 Brandl St, Eight Mile Plains, QLD 4113) (NATA = National Association of Testing Authorities; AQIS = Australian Quarantine and Inspection Service).
- Pre-packed in 5ml sachets for clinical use
- Stored at room temperature
- Certified shelf-life: 3 years
- Chemical Attributes: Cocos Nucifera 100%

The coconut oil will be provided to parents in single use sachets (5ml).
The coconut oil will be used twice daily for topical application to the burns areas.
Parents will receive training and treatment instructions for how to apply the coconut oil by the treating clinician.
Parents and children will be approached to participate in the study at their outpatient clinic appointment, where they will be randomised into the control or intervention arm of the study.
Parents and children will be shown how to apply the coconut oil to the burns and wound scar areas by the clinic nurse or doctor. The coconut oil is packaged is single use sachets. Application of the coconut oil is a very simple process and will take less than 10 minutes to show the parents and child (if old enough) how to apply the oil.

Patient compliance will be monitored using a daily e-Diary. The daily e-diary is automatically sent to the parent and can be completed on a smartphone. The e-diary will record information regarding compliance to treatment as well as reasons for non-compliance. The child's response to receiving coconut oil is also recorded (refused, reluctant, accepting, content, relief)
Intervention code [1] 325206 0
Treatment: Other
Comparator / control treatment
Patients randomised to the control group will continue with standard care using sorbelene for care of burns scars. Parents will be requested to apply sorbelene twice daily to burns and wound scars. This is the current standard treatment.
Parents in the control group will receive a daily e-diary to record how many times sorbelene was applied, and if less than twice requested to provide a reason.. The child's response to receiving sorbelene is also recorded (refused, reluctant, accepting, content, relief)
Control group
Active

Outcomes
Primary outcome [1] 333551 0
Wound healing
1. Surface re-epithelialisation
-Clinical assessment of skin surface epithelialisation, with information stored using photography.
-Re-epithelialisation is defined as over 95% wound healing and no requirement for further wound dressing. Scabs or crusts are defined as unhealed areas. This endpoint is doubly assessed. In the clinic the treating doctor assesses percentage re-epithelialisation. It is further assessed from digital photography by an independent surgeon blinded to the intervention.
-Photographs will be taken at each dressing change and at each subsequent clinic visit for care. In the clinic a visual percentage re-epithelialisation will be requested. The blinded observer will subsequently mark out the edges of the wound, and any unhealed areas.
-Surface area computer mapping will then be used to determine percentage re-epithelialisation.
Timepoint [1] 333551 0
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks post commencement of intervention.
Primary outcome [2] 333552 0
Wound healing
(2) Skin surface lipidomics

- Skin surface chemistry will be assessed using nitrocellulose sheet placed topically for 5 minutes at each site and stored dry for later lipidomic analysis
Timepoint [2] 333552 0
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks post commencement of intervention
Secondary outcome [1] 417494 0
Changes in skin microbiome

- Swabs will be taken from the surgically treated burns wound (STBW) the conservatively managed wounds (CMW) and and donor site wounds (DSW) and a contralateral non injured equivalent body part as a control at each review interval in order to assess the microbiome
.
- Bacterial populations will be sampled using a FLOQswab premoistened in sterile saline, skin sampling performed by spinning the swab for 30 s across a 4 cm2 area while applying moderate pressure. The swab tip will be placed in a sterile 1.5 ml microcentrifuge Epindorf tube and stored at -70 °C for later analysis by qPCR.

- Assessment of efficacy will be comparing the skin microbiome from an untreated and unaffected site to the treated sites, comparing the bacterial populations
Timepoint [1] 417494 0
Baseline, 2 weeks, 4 weeks, 8 weeks, 12 weeks post commencement of intervention
Secondary outcome [2] 418116 0
Participants will be monitored for adverse events.
Any complications that relate to burn injury and treatment that relate to the definition of a serious adverse event (SAE) will be acted on by the clinical team and reported in accordance with the study protocol.
Any complications that relate to the burn or treatment that do not meet the criteria for an SAE will be acted on, captured and recorded. An SAE may include an allergic reaction to coconut oil or wound infection, and an AE may include itching, stinging or unexpected pain.
Adverse events will reported daily via the daily e-diary.
Any events or areas for concern will be discussed and recorded at each clinic appointment
Timepoint [2] 418116 0
Any adverse event or areas for concern will be reported daily by the e-diary
Any adverse event or areas for concern will also be discussed and recorded at clinics appointments at 2 weeks post baseline (first appointment), 4 weeks, 8 weeks and 12 weeks.
Secondary outcome [3] 418117 0
Adherence to treatment will be measured by the daily e-diary. Parents will be asked to record the number of times coconut oil or the control (sorbelene) was applied to the child's wound scars, and the reason if less than 2 times.
The child's response is also measured in a scale of 1 to (refused, reluctant, accepting, content, relief)
Timepoint [3] 418117 0
Adherence will be measured daily from baseline - clinic 1, randomisation and continue for the 12 week study period.

Eligibility
Key inclusion criteria
– Male or female children, 16 years of age or younger
– Treated for burns in the Burns Surgery Department at Perth Children;s Hospital
– less than 20% total body surface area burns
– Early healing phase of burns treatment
– Formal dressings no longer required
– Informed written consent
Minimum age
0 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
– Known allergy to coconut oil
– Unable to attend regular follow up clinic appointments at Perth Children's Hospital
– Diabetic

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)
Simple randomisation using a randomisation table created by computer software (i.e. 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
Safety/efficacy
Statistical methods / analysis
We will enrol 100 participants in this pilot study. Robust sample size calculations are not possible for this small pilot study. This sample size is feasible to recruit in the timeframe proposed and we anticipate it will provide sufficient preliminary data to inform the design, including required sample size, for future studies to demonstrate the efficacy of the intervention. The data generated will inform consultation with consumers and clinicians to guide the further development of this novel treatment approach including the design of a larger multi-centre randomised controlled trial to assess efficacy.

This is a pilot study, with estimates of clinical effects of the intervention compared to standard care being used to inform the design future trials to confirm the efficacy of the intervention. We will perform between group comparisons for each primary and secondary outcome at the end of the study.
Adverse events, including SAEs will be reported in frequency tables. The proportion of participants experiencing AEs in each group will be calculated.
Overall treatment adherence (total number of doses on which the coconut oil was applied divided by total number of days in the intervention period for all participants) will be calculated. The proportion of participants with full, partial and non-adherence to treatment will be calculated

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2023
Actual
Date of last participant enrolment
Anticipated
30/06/2024
Actual
Date of last data collection
Anticipated
30/09/2024
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 23822 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 39275 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 312964 0
Government body
Name [1] 312964 0
Western Australian Department of Health
Country [1] 312964 0
Australia
Funding source category [2] 313178 0
Commercial sector/Industry
Name [2] 313178 0
Northern Star Resources Limited
Country [2] 313178 0
Australia
Primary sponsor type
Hospital
Name
Perth Children's Hospital (Child and Adolescent Health Service)
Address
Perth Children's Hospital
15 Hospital Ave,
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 314652 0
None
Name [1] 314652 0
Address [1] 314652 0
Country [1] 314652 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312235 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 312235 0
Ethics committee country [1] 312235 0
Australia
Date submitted for ethics approval [1] 312235 0
15/08/2022
Approval date [1] 312235 0
02/11/2022
Ethics approval number [1] 312235 0
RGS0000003254

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

Contacts
Principal investigator
Name 123938 0
Prof Fiona Wood
Address 123938 0
Burns Unit
Perth Children's Hospital
15 Hospital Avenue, Nedlands, Perth WA 6009
Country 123938 0
Australia
Phone 123938 0
+61 8 6456 3620
Fax 123938 0
Email 123938 0
[email protected]
Contact person for public queries
Name 123939 0
Fiona Wood
Address 123939 0
Burns Unit
Perth Children's Hospital
15 Hospital Avenue, Nedlands, Perth WA 6009
Country 123939 0
Australia
Phone 123939 0
+61 8 6456 3620
Fax 123939 0
Email 123939 0
[email protected]
Contact person for scientific queries
Name 123940 0
Fiona Wood
Address 123940 0
Burns Unit
Perth Children's Hospital
15 Hospital Avenue, Nedlands, Perth WA, 6009
Country 123940 0
Australia
Phone 123940 0
+61 8 6456 3620
Fax 123940 0
Email 123940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No additional documents have been identified.