None listed
Conditions
Brief summary
This pilot study aims to demonstrate the effects of using coconut oil compared to standard therapy (sorbelene cream) for the treatment of burns scars. Burn injuries in children are common and result in painful wounds with a varying capacity to heal. Time to healing is key in driving long-term scar outcomes. Deeper wounds will be treated surgically with a combination of traditional skin grafts and cell-based therapies. Standard of care (SOC) is to commence skin moisturizing the newly sealed wounds with massage of topical ointments to prevent surface drying and secondary disruption of the surface and associated infections, which usually occur between 7 to 14 days post operation. Coconut oil is rich in fatty acids, which have natural activity against common skin microbes and inflammation. Coconut oil for skin care has been shown to improve skin condition. Laboratory studies have shown that Monolaurin (the primary fatty acid in coconut oil), at the concentrations present in the coconut oil used for skin care, has substantial antimicrobial activity. In this pilot randomised controlled trial we aim to assess the healing properties of virgin coconut oil in the treatment of burns injuries. We will randomise 100 paediatric burns patients to either receive coconut oil or standard care (sorbelene cream) for burns care. In the intervention group coconut oil will be applied twice per day to surgically managed burn wound sites, skin graft donor sites and conservatively managed burn wound sites for a period of 12 weeks. In the control group, patients will receive routine care (sorbelene cream) forburn wound sites, skin graft donor sites and conservatively managed burn wound sites for the same time period. This study will provide valuable pilot data for the potential role of coconut oil in children with burns, which will be used to design future large multi-centre studies and potentially change the standard of care.
Interventions
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
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)
Sponsors
Perth Children's Hospital (Child and Adolescent Health Service)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to 16 Years
Healthy volunteers
No
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
Exclusion criteria
– Known allergy to coconut oil – Unable to attend regular follow up clinic appointments at Perth Children's Hospital – Diabetic
Outcome results
None listed