ANZCTR - Registration

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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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Face burn

Condition category

Condition code

Injuries and Accidents

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]

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]

Length of hospital stay, assessed by review of hospital records.

Timepoint [1]

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]

Frequency of application will be assessed by review of hospital records.

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment postcode(s) [1]

5006 - North Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Women's and Children's Hospital

Address [1]

Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006

Country [1]

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]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

WCHN Human Research Ethics Committee (HREC)

Ethics committee address [1]

Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

14/05/2015

Approval date [1]

29/09/2015

Ethics approval number [1]

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

Dr Puvesh Punj

Address

Department of Paediatric Burns
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006

Country

Australia

Phone

+618 8161 7000

Fax

puvesh@gmail.com

Contact person for public queries

Name

Linda Quinn

Address

Department of Paediatric Burns
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006

Country

Australia

Phone

+618 8161 7000

Fax

linda.quinn@health.sa.gov.au

Contact person for scientific queries

Name

Puvesh Punj

Address

Department of Paediatric Burns
Women's and Children's Hospital
72 King William Road
North Adelaide
South Australia
5006

Country

Australia

Phone

+618 8161 7000

Fax

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

Source	Title	Year of Publication	DOI
Embase	Topical treatment for facial burns.	2020	https://dx.doi.org/10.1002/14651858.CD008058.pub3

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

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Documents added manually

Documents added automatically