Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001205527
Ethics application status
Approved
Date submitted
6/10/2015
Date registered
5/11/2015
Date last updated
5/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
White soft paraffin vs Glucan Pro 'Registered Trademark' 3000 ointment for Face Burns
Scientific title
White soft paraffin vs Glucan Pro 'Registered Trademark' 3000 ointment for Face Burns. A Randomized, Blinded Trial Evaluating the Topical Management of Paediatric Facial Burns
Secondary ID [1] 287617 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Face burn 296422 0
Condition category
Condition code
Injuries and Accidents 296686 296686 0 0
Burns

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are trialing a new product, Glucan Pro 'Registered Trademark' 3000, an ointment that contains paraffin wax and other active ingredients mainly oat beta glucan, an oat derivative which is currently indicated for the management of superficial abrasions, scrapes, and cuts. It has been used for non-facial burns in children with good results. It is hypothesised that Glucan Pro 'Registered Trademark' will result in decreased frequency of application and reduced duration of administration by improved time of healing. This will be monitored by the "nursing daily face care checklist". Treating nurse will apply the product using standard face care guidelines located within the Clinical Standard Guidelines Folder of the Women's and Children's Health Network and volume of product is at nursing discretion depending on size of the affected area. Treating nurse will document moisture state of wound every 2 hours whilst awake using a Likert scale 1 (dry) to 5 (moist), with any score of 3 or less will require re-application of product.

The product (Glucan Pro 'Registered Trademark' 3000) will be administered depending on the score given on the "Likert Wound Moisture Scale" by the treating nurse following review of the moisture state of wound every 2 hours whilst awake for 7 days.
Intervention code [1] 293008 0
Treatment: Other
Comparator / control treatment
The product (white soft paraffin) will be administered depending on the score given on the "Likert Wound Moisture Scale" by the treating nurse following review of the moisture state of wound every 2 hours whilst awake for 7 days.
Control group
Active

Outcomes
Primary outcome [1] 296292 0
Length of hospital stay, assessed by review of hospital records.

Timepoint [1] 296292 0
From time of hospital admission to time of hospital discharge. In cases of multiple burn wounds, timepoint is from time of hospital admission to time of suitability for discharge for face burn. (ie. when care of the face burn can be transferred to an outpatient/home setting)
Secondary outcome [1] 318092 0
Frequency of application will be assessed by review of hospital records.
Timepoint [1] 318092 0
From time of first application to time of final application

Eligibility
Key inclusion criteria
Paediatric population ( age <18)
A component of partial thickness, facial burn injury requiring admission for management
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Obvious full thickness burn wounds to face
Infected burn wounds
Allergy to any of the ingredients in either product

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)
A random sequence [1(White soft paraffin) or 2 (Glucan Pro'Registered Trademark' 3000)] was generated by the Department of Pharmacy using a computer-generated random number table.
Products were labelled alphabetically in order from A to Z with information pertaining to the contents ( ie 1 or 2), stored securely in the Department of Pharmacy. All trial researchers assessing, administering and analysing the trial as well as nursing staff, participants are blinded to this information.
As soon as a patient which meets the above inclusion criteria is recruited, the product will be obtained in sequence (alphabetically from A-Z) from the storage site ( secured drug room on Newland ward)
Product to be charted in medication chart according to label of container.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A random sequence [1(White soft paraffin) or 2 (Glucan Pro'Registered Trademark' 3000)] was generated by the Deparment of Pharmacy using a computer-generated random number table.
Products were labelled alphabetically in order from A to Z with information pertaining to the contents ( ie 1 or 2), stored securely in the Department of Pharmacy. All trial researchers assessing, administering and analysing the trial as well as nursing staff, participants are blinded to this information.
As soon as a patient which meets the above inclusion criteria is recruited, the product will be obtained in sequence (alphabetically from A-Z) from the storage site ( secured drug room on Newland ward)
Product to be charted in medication chart accoding to label of container.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
16/11/2015
Actual
Date of last participant enrolment
Anticipated
31/12/2017
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 4435 0
Womens and Childrens Hospital - North Adelaide
Recruitment postcode(s) [1] 10640 0
5006 - North Adelaide

Funding & Sponsors
Funding source category [1] 292177 0
Hospital
Name [1] 292177 0
Women's and Children's Hospital
Country [1] 292177 0
Australia
Primary sponsor type
Hospital
Name
Women's and Children's Hospital
Address
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006
Country
Australia
Secondary sponsor category [1] 290850 0
None
Name [1] 290850 0
None
Address [1] 290850 0
None
Country [1] 290850 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293651 0
WCHN Human Research Ethics Committee (HREC)
Ethics committee address [1] 293651 0
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006
Ethics committee country [1] 293651 0
Australia
Date submitted for ethics approval [1] 293651 0
14/05/2015
Approval date [1] 293651 0
29/09/2015
Ethics approval number [1] 293651 0
HREC/15/WCHN/79

Summary
Brief summary
Burns to the face are very common among children. They are caused by scalds from hot liquid or less commonly flash flame burns. Care for burns to the face usually require admission for pain management and regular cleaning with saline soaked gauze (up to three times a day) followed by the application of white soft paraffin (every two to four hours) throughout the day.

We are trialling a new product, Glucan Pro 'Registered Trademark' 3000, an ointment that contains paraffin wax and other active ingredients mainly oat beta glucan, an oat derivative which is currently indicated for the management of superficial abrasions, scrapes, and cuts. It has been used for non-facial burns in children with good results

Aims:

1) Length of stay:

Glucan Pro 'Registered Trademark' 3000 provides an occlusive layer similar to white soft paraffin for wound healing, however the active ingredients (oat beta glucan) has been shown to have a beneficial effect in nonfacial burns.

We hypothesise that Glucan Pro 'Registered Trademark' 3000 application to facial burns will acclerate the healing process and result in a reduction in length of hospital stay.


2) Reduction in frequency of application:

The current standard of care includes the application of white soft paraffin (every 2-4 hours) to keep the burn wound moist.

We hypothesise that Glucan Pro 'Registered Trademark' 3000 will result in a reduction in frequency of application and thus provide a more comforting environment for the paediatric patient.

Adverse event:
There is a small risk of an allergic reaction with topical treaments (ie. rash), and if this occurs we will stop using the product, seek appropriate medical advice and revert to the usual course of treatment.
If infection is identified, participant will be withdrawn from the trial and appropriate medical management will be instituted.
All adverse events will be reported to the Department of Pharmacy, Clinical Governance Unit and Women’s and Children’s Health Network Ethics Committee.

Analysis:
Results of the trial will be analysed using the intention to treat (ITT) methodology.
Daily wound review checklist will be analysed to determine variability in the frequency of application of each product

Trial review:
Conduct and progress of the trial will be reviewed and updated weekly
Burns Research/Business Meeting (Wednesday, Level 2, Surgical Services)


What are the possible risks:

There is a small risk of an allergic reaction with topical treaments (ie. rash), and if this occurs we will stop using the product, seek appropriate medical advice and revert to the usual course of treatment.

There may be no direct benefit from the use of Glucan Pro 'Registered Trademark' 3000
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 60834 0
Dr Puvesh Punj
Address 60834 0
Department of Paediatric Burns
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006
Country 60834 0
Australia
Phone 60834 0
+618 8161 7000
Fax 60834 0
Email 60834 0
puvesh@gmail.com
Contact person for public queries
Name 60835 0
Ms Linda Quinn
Address 60835 0
Department of Paediatric Burns
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006
Country 60835 0
Australia
Phone 60835 0
+618 8161 7000
Fax 60835 0
Email 60835 0
linda.quinn@health.sa.gov.au
Contact person for scientific queries
Name 60836 0
Dr Puvesh Punj
Address 60836 0
Department of Paediatric Burns
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006
Country 60836 0
Australia
Phone 60836 0
+618 8161 7000
Fax 60836 0
Email 60836 0
puvesh@gmail.com

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseTopical treatment for facial burns.2020https://dx.doi.org/10.1002/14651858.CD008058.pub3
N.B. These documents automatically identified may not have been verified by the study sponsor.