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White soft paraffin vs Glucan Pro 'Registered Trademark' 3000 ointment for Face Burns

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615001205527
Enrollment
20
Registered
2015-11-05
Start date
2015-11-16
Completion date
2017-12-31
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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 If infection is identified, participant will be withdrawn from the trial and appropriate medical management will be instituted.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

Interventions

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 impro

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.

Sponsors

Women's and Children's Hospital
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years
Healthy volunteers
No

Inclusion criteria

Paediatric population ( age <18) A component of partial thickness, facial burn injury requiring admission for management

Exclusion criteria

Obvious full thickness burn wounds to face Infected burn wounds Allergy to any of the ingredients in either product

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026