The Honeypot Study Protocol: A Randomized Controlled Trial of Exit-Site Application of Medihoney Antibacterial Wound Gel for the Prevention of Catheter-Associated Infections in Peritoneal Dialysis PatientsPerit Dial Int, 2009 May;29(3):303-309
Objectives: The primary objective of this study is to determine whether daily exit-site application of standardized antibacterial honey (Medihoney Antibacterial Wound Gel; Comvita, Te Puke, New Zealand) results in a reduced risk of catheter-associated infections in peritoneal dialysis (PD) patients compared with standard topical mupirocin prophylaxis of nasal staphylococcal carriers.
Design: Multicenter, prospective, open label, randomized controlled trial.
Setting: PD units throughout Australia and New Zealand.
Participants: The study will include both incident and prevalent PD patients (adults and children) for whom informed consent can be provided. Patients will be excluded if they have had (1) a history of psychological illness or condition that interferes with their ability to understand or comply with the requirements of the study; (2) recent (within 1 month) exit-site infection, peritonitis, or tunnel infection; (3) known hypersensitivity to, or intolerance of, honey or mupirocin; (4) current or recent (within 4 weeks) treatment with an antibiotic administered by any route; or (5) nasal carriage of mupirocin-resistant Staphylococcus aureus.
Methods: 370 subjects will be randomized 1:1 to receive either daily topical exit-site application of Medihoney Antibacterial Wound Gel (all patients) or nasal application of mupirocin if staphylococcal nasal carriage is demonstrated. All patients in the control and intervention groups will perform their usual exit-site care according to local practice. The study will continue until 12 months after the last patient is recruited (anticipated recruitment time is 24 months).
Main Outcome Measures: The primary outcome measure will be time to first episode of exit-site infection, tunnel infection, or peritonitis, whichever comes first. Secondary outcome measures will include time to first exit-site infection, time to first tunnel infection, time to first peritonitis, time to infection-associated catheter removal, catheter-associated infection rates, causative organisms, incidence of mupirocin-resistant microbial isolates, and other adverse reactions.
Conclusions: This multicenter Australian and New Zealand study has been designed to provide evidence to help nephrologists and their PD patients determine the optimal strategy for preventing PD catheter-associated infections. Demonstration of a significant improvement in PD catheter-associated infections with topical Medihoney will provide clinicians with an important new prophylactic strategy with a low propensity for promoting antimicrobial resistance.
Setting: PD units throughout Australia and New Zealand.
Participants: The study will include both incident and prevalent PD patients (adults and children) for whom informed consent can be provided. Patients will be excluded if they have had (1) a history of psychological illness or condition that interferes with their ability to understand or comply with the requirements of the study; (2) recent (within 1 month) exit-site infection, peritonitis, or tunnel infection; (3) known hypersensitivity to, or intolerance of, honey or mupirocin; (4) current or recent (within 4 weeks) treatment with an antibiotic administered by any route; or (5) nasal carriage of mupirocin-resistant Staphylococcus aureus.
Methods: 370 subjects will be randomized 1:1 to receive either daily topical exit-site application of Medihoney Antibacterial Wound Gel (all patients) or nasal application of mupirocin if staphylococcal nasal carriage is demonstrated. All patients in the control and intervention groups will perform their usual exit-site care according to local practice. The study will continue until 12 months after the last patient is recruited (anticipated recruitment time is 24 months).
Main Outcome Measures: The primary outcome measure will be time to first episode of exit-site infection, tunnel infection, or peritonitis, whichever comes first. Secondary outcome measures will include time to first exit-site infection, time to first tunnel infection, time to first peritonitis, time to infection-associated catheter removal, catheter-associated infection rates, causative organisms, incidence of mupirocin-resistant microbial isolates, and other adverse reactions.
Conclusions: This multicenter Australian and New Zealand study has been designed to provide evidence to help nephrologists and their PD patients determine the optimal strategy for preventing PD catheter-associated infections. Demonstration of a significant improvement in PD catheter-associated infections with topical Medihoney will provide clinicians with an important new prophylactic strategy with a low propensity for promoting antimicrobial resistance.
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