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 Patients

Abstract

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.

Peritoneal dialysis practice in Australia and New Zealand: A call to action

“…17 A randomized controlled trial is currently underway to investigate daily exit-site application of standardized antibacterial honey. 67 The ANZDATA registry does not record the application of a topical antimicrobial agent to the exit site; however, given the variability in peritonitis rates (Fig. 2), this practice may not be routine in all PD units.…”

Multicentre prospective observational study on professional wound care using honey (Medihoney™)

“…Honey has been used to promote wound healing for many centuries all over the world (1,2). Recent in vitro studies demonstrating its broad spectrum of antimicrobial activity (3–7) have revived interest in the use of honey in professional wound care (8), especially its activity against antibiotic‐resistant bacteria such as methicillin‐resistant Staphylococcus aureus (MRSA) (9–11). Honey derived from the floral source Leptospermum scoparium (manuka) has therapeutic advantages over other honey because of its notable antibacterial effects (12).…”

“…Not only honey's antibacterial properties but also its ability to accelerate wound healing has been demonstrated in a large number of case studies using specific honey products to treat a wide range of chronic and acute wounds (1,2,9–11,14,20). In recent years, the benefits of therapeutic honey have been gaining interest in German‐speaking countries as the first publications from Europe have appeared in the last few years (15–17).…”

Beyond Pollination: Honey Bees (Apis mellifera) as Zootherapy Keystone Species

“…Medihoney R comes in the form of paste, gel, and dressing to aid wounds and burns (George and Cutting, 2007). Both Comvita R and Medihoney R were studied in a randomized control trial examining the use of the antibacterial against catheter-associated infections (Johnson et al, 2009). Revamil R wound care from Bfactory uses medical grade honey-produced under controlled conditions in greenhouses-and is approved for topical application for wound healing.…”