None listed
Conditions
Brief summary
The largest problem faced by peritoneal dialysis patients is infection of their dialysis catheter, which can occur at the point of entry of the catheter into the belly (exit site infection), along the catheter tunnel (tunnel infection) or inside the belly (peritonitis). Such infections are the commonest cause of death or failure of treatment in peritoneal dialysis patients at Princess Alexandra Hospital. Recent studies have suggested that honey may be a promising agent for preventing catheter-associated infections. Honey has natural antibacterial and antifungal actions and has been shown to be very effective in preventing infection when applied to a variety of wounds, including burns, ulcers and surgical wounds. A previous controlled trial by our group in haemodialysis patients showed that honey was as effective as, and less likely to select resistant germs than, standard antibiotic ointment (mupirocin). The purpose of the present proposed study is to determine if exit site application of standardised antibacterial honey (Medihoney Wound Gel) is more effective at preventing infection of peritoneal dialysis catheters than the standard antibiotic ointment, mupirocin, which is currently recommended by national guidelines.
Interventions
Daily exit site application of gamma-irradiated, commercially available, pooled antibacterial honeys including Leptospermum sp honey (Medihoney™ Antibacterial Wound Gel, Medihoney Pty Ltd, Australia; approximately 10 mg) following exit site cleaning and drying as per standard local practice for the duration of the study. Trial participants will be treated and followed up for 12 months from the entry of the last patient in the study. Recruitment is expected to take 2 years and median trial trea
Daily exit site application of gamma-irradiated, commercially available, pooled antibacterial honeys including Leptospermum sp honey (Medihoney™ Antibacterial Wound Gel, Medihoney Pty Ltd, Australia; approximately 10 mg) following exit site cleaning and drying as per standard local practice for the duration of the study. Trial participants will be treated and followed up for 12 months from the entry of the last patient in the study. Recruitment is expected to take 2 years and median trial treatment and follow up is expected to be 18 months.
Sponsors
Australasian Kidney Trials Network
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No
Inclusion criteria
Receiving peritoneal dialysis. Able to give informed consent.
Exclusion criteria
Patients with a history of psychological illness or condition which interferes with their ability to understand or comply with the requirements of the study. Recent (within 1 month) exit site infection, peritonitis, or tunnel infection. Known hypersensitivity to, or intolerance of, honey or mupirocin. On long term antibiotics. Nasal carriage of mupirocin resistant Staphylococcus aureus.
Outcome results
None listed