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

2009 ◽  
Vol 29 (3) ◽  
pp. 303-309 ◽  
Author(s):  
David W. Johnson ◽  
Carolyn Clark ◽  
Nicole M. Isbel ◽  
Carmel M. Hawley ◽  
Elaine Beller ◽  
...  

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.

1994 ◽  
Vol 14 (1) ◽  
pp. 17-21 ◽  
Author(s):  
Charles H. Crompton ◽  
J. Williamson Balfe ◽  
Antoine Khoury

Objectives To describe our experience with chronic ambulatory peritoneal dialysis in children with the prune belly syndrome (PBS). Design From our peritoneal dialysis (PD) program we were able to review the medical records of 6 boys with PBS. Data were collected on potential complications such as infections, hernias, growth, and problems encountered with PD catheter insertion. Results The ages of the 6 boys ranged from 10 months 17 years. The dialysis duration was from 9–22 months, with a total of 76 patient-months on PD. There was one death, possibly as a complication of an exit-site infection. Five received a renal transplant, and 4 have functioning grafts. Peritonitis occurred once in every 10.8 patient months, and exit-site or tunnel infection was diagnosed every 7.6 patient-months. Four patients required PD catheter replacement because of tunnel infection in 2, persistent exit-site infection in 1, and fluid leakage in 1. Of a total of nine catheters, three were inserted using a laparoscopic technique. There were no leaks in these three; however, there was one exit-site infection. Two patients had inguinal hernias that required surgery. Conclusion Deficiency of abdominal musculature in PBS poses potential problems for the use of PD, in particular, catheter anchorage, exit-site healing, and leakage. In our patients the most serious complications were infections of the exit site or catheter tunnel. Our experience suggests that a laparoscopic technique may provide improved catheter placement. PD offers a potentially successful form of dialysis for patients with PBS.


1999 ◽  
Vol 19 (5) ◽  
pp. 451-454 ◽  
Author(s):  
Yao-Ming Wu ◽  
Meng-Kun Tsai ◽  
Seh-Huang Chao ◽  
Tun-Jun Tsai ◽  
King-Jen Chang ◽  
...  

Objective Catheter-related infection has been the major cause of catheter removal for peritoneal dialysis (PD) patients. A salvage technique — partial replantation of the infected catheter — was developed in our hospital to rescue catheters with refractory exit-site or tunnel infection. Patients We performed 26 partial replantations of Tenckhoff catheters for 23 patients with refractory exitsite or tunnel infection and 2 patients with near-cuff perforation of the catheter. Their problems were all resolved successfully without interruption of PD. Interventions We removed the infected portion of the catheter and preserved the still-functioning internal conduit, connecting it to a divided new catheter. All of the patients resumed PD immediately after the advancement of the new catheter through a new subcutaneous tunnel and exit site on the opposite side. Results No technical complications such as disconnection of the catheter or leakage of dialysate were noted. Repeated partial replantation of the catheter was done for 1 patient with a new refractory exit-site infection. Tunnel infection was not an absolute contraindication for this procedure. About one third (34.6%) of our patients had preoperative tunnel infection. Conclusion Partial replantation of a Tenckhoff catheter is a simple and effective procedure for patients with refractory exit-site/tunnel infection and patients with near-cuff perforation of the catheter. Repeated partial replantation is also feasible for repeat exit-site infections.


2006 ◽  
Vol 26 (6) ◽  
pp. 677-683 ◽  
Author(s):  
John H. Crabtree ◽  
Raoul J. Burchette

Objective Guidelines for optimal peritoneal dialysis access support both downward and lateral exit-site directions. Numerous clinical reports support the superiority of downward exit sites but none substantiate lateral configurations. Methods This prospective study compared infectious and mechanical complications between 85 catheters with a preformed arcuate bend to produce a downward exit site and 93 catheters with a straight intercuff segment configured to create a lateral exit site. Results Kaplan–Meier survivals were not different for time to first exit-site infection ( p = 0.62), tunnel infection ( p = 0.89), or peritonitis ( p = 0.38) for downward and lateral exit-site directions. Poisson regression showed no differences in rates (episodes/patient-year) of exit-site infection (0.26 vs 0.27, p = 0.86), tunnel infection (0.02 vs 0.03, p = 0.79), peritonitis (0.42 vs 0.43, p = 0.87), or catheter loss (0.06 vs 0.09, p = 0.29) for downward and lateral exit sites. Kaplan–Meier analyses of antibiotic-free intervals for exit-site ( p = 0.94) and peritonitis infections ( p = 0.72) were not different for the two groups. There was one case of catheter tip displacement with flow dysfunction in each group. There were no pericatheter hernias or spontaneous cuff extrusions. Catheter survival between groups was not different ( p = 0.20). Conclusions Catheter types employing downward and lateral tunnel-tract and exit-site configurations produce equivalent outcomes for infectious and mechanical complications.


2016 ◽  
Vol 36 (2) ◽  
pp. 135-139 ◽  
Author(s):  
Lily Mushahar ◽  
Lim Wei Mei ◽  
Wan Shaariah Yusuf ◽  
Sudhaharan Sivathasan ◽  
Norilah Kamaruddin ◽  
...  

ObjectivePeritoneal dialysis (PD)-related infection is a common cause of catheter loss and the main reason for PD drop-out. Exit-site infection (ESI) is a pathway to developing tunnel infection and peritonitis, hence rigorous exit-site care has always been emphasized in PD therapy. The aim of this study was to evaluate the effect of exit-site dressing vs non-dressing on the rate of PD-related infection.MethodsA prospective randomized controlled study was conducted in prevalent PD patients at the Hospital Tuanku Jaafar Seremban, Negeri Sembilan, Malaysia, from April 2011 until April 2013. All patients were required to perform daily washing of the exit site with antibacterial soap during a shower. In the dressing group ( n = 54), patients were required to clean their exit site using povidone-iodine after drying, followed by topical mupirocin antibiotic application to the exit site. The exit site was then covered with a sterile gauze dressing and the catheter immobilized with tape. In the non-dressing group ( n = 54), patients were not required to do any further dressing after drying. They were only required to apply mupirocin cream to the exit site and then left the exit site uncovered. The catheter was immobilized with tape. The primary outcome was ESI. The secondary outcomes were evidence of tunnel infection or peritonitis.ResultsA total of 97 patients completed the study. There were a total of 12 ESI episodes: 4 episodes in 4 patients in the dressing group vs 8 episodes in 4 patients in the non-dressing group. This corresponds to 1 episode per 241.3 patient-months vs 1 episode per 111.1 patient-months in the dressing and non-dressing groups respectively. Median time to first ESI episode was shorter in the non-dressing than in the dressing group, but not significant ( p = 0.25). The incidence of gram-positive ESI in both groups was similar. There were no gram-negative ESI in the non-dressing group compared with 2 in the dressing group. The peritonitis rate was 1 per 37.1 patient-month in the dressing group and 1 per 44.4 patient-months in the non-dressing group. Median time to first peritonitis episode was significantly shorter in the dressing group compared to non-dressing ( p = 0.03). There was no impact of dressing disruptions in the occurrence of major PD catheter-related infection.ConclusionUse of a non-dressing technique with only prophylactic topical mupirocin cream application is effective in preventing PD-related infection. The non-dressing technique is more cost-effective and convenient for PD patients, with fewer disposables.


2008 ◽  
Vol 28 (3_suppl) ◽  
pp. 179-182
Author(s):  
Man-Chun Chiu ◽  
Pak-Chiu Tong ◽  
Wai-Ming Lai ◽  
Shing-Chi Lau

We reviewed 30 patients in an automated peritoneal dialysis (APD) program from 2002 to 2006 for peritonitis. Patients were 11.6 ± 5.5 years old at initiation of peritoneal dialysis (PD) and had a total of 976 PD months. The overall peritonitis rate was 1 episode in 54.2 patient– months, for a rate of 0.22 episode annually. The rate was considered low, which other than being an APD program, may be attributed to adherence to guidelines and in-charge nurse policy. A total of 17 episodes of peritonitis were identified in 9 patients, and the distribution of patient-specific peritonitis incidence appeared bimodal: 87% patients had no or only 1 episode of peritonitis, and 4 patients accounted for 12 episodes, with an average peritonitis rate of 1.0 annually. Causative organisms included Staphylococcus aureus, coagulase-negative Staphylococcus, methicillin-resistant S. aureus (MRSA), Pseudomonas aeruginosa, enterococci, alpha-hemolytic Streptococcus. Five episodes had concurrent exit-site infection with the same organism. During the same period in these 30 patients, 40 episodes of exit-site infection (ESI) were recorded in 23 patients. The overall ESI rate was 1 episode in 24.4 PD months. S. aureus and Pseudomonas aeruginosa were the two most common pathogens, accounting for 70% of the infections. Nasal carriage of MRSA was found in 4 patients, and MRSA ESIs in 2. The ESI rate was not low as that observed in peritonitis, which may be attributed to the humid climate.


1996 ◽  
Vol 7 (11) ◽  
pp. 2403-2408

A total of 1144 patients receiving continuous ambulatory peritoneal dialysis in nine European centers was screened for nasal carriage of Staphylococcus aureus. Two hundred sixty-seven subjects were defined as carriers of S. aureus by having had at least two positive swab results from samples taken on separate occasions, and were randomly allocated to treatment or control groups. Members of each group used a nasal ointment twice daily for 5 consecutive days every 4 wk. The treatment group used calcium mupirocin 2% (Bactroban nasal; SmithKline Beecham, Welwyn Garden City, United Kingdom) and the control group used placebo ointment. Patients were followed-up for a maximum period of 18 months. There were 134 individuals in the mupirocin group, and 133 individuals acted as control subjects. There were no differences in demographic data, cause of renal failure, type of catheter, system used, or method of exit-site care between the groups. Similarly, there were no differences in patient outcome or incidence of adverse events between both groups. Nasal carriage fell to 10% in those subjects who received active treatment and 48% in those who used the placebo ointment. There were 55 exit-site infections in 1236 patient-months in the control group and 33 in 1390 patient-months in the treatment group (not significant). S. aureus caused 14 episodes of exit-site infection in the mupirocin group and 44 in the control group (P = 0.006, mixed effects Poisson regression model). There were no differences in the rate of tunnel infection or peritonitis. There was no evidence of a progressive increase in resistance to mupirocin with time. Regular use of nasal mupirocin in continuous ambulatory peritoneal dialysis patients who are nasal carriers of S. aureus significantly reduces the rate of exit-site infections that occurs because of this organism.


1993 ◽  
Vol 13 (2_suppl) ◽  
pp. 232-335 ◽  
Author(s):  
Beth Piraino ◽  
Jeffrey A. Perlmutter ◽  
Jean L. Holley ◽  
Judith Bernardini

Although the definition of S. aureus nasal carriage in peritoneal dialysis patients Is variable, carriage is often defined as 2 or more positive cultures for S. aureus. We Investigated the relationship between S. aureus Infections and nasal carriage (defined as 1 or more positive nose cultures) In 138 patients on peritoneal dialysis. By this definition, approximately 50% of the patients were carriers. The rates of S. aureus exit-site infection (0.28/year vs 0.43/year, p<0.001) and peritonitis (0.08/year vs 0.20/year, p<0.001) were lower in the noncarriers (patients with no positive nose cultures) than in those patients who had 1 or more positive nose cultures. Patients with only 1 positive nose culture had a similar S. aureus exit-site infection rate (0.31/year vs 0.28/year), but a higher peritonitis rate (0.24/year vs 0.08/year, p<0.001) compared to those petients with no positive nose cultures. However, patients with 2 or more positive nose cultures were at Increased risk for both S. aureus exit-site Infections and peritonitis. This relationship held even when only petients with frequent nose cultures were Included In the analysis. Thus patients with even 1 positive nose culture for S. aureus are at risk for S. aureus peritonitis and should not be classified as noncarriers.


2016 ◽  
Vol 36 (6) ◽  
pp. 684-687 ◽  
Author(s):  
Thomas A. Forbes ◽  
Loren Shaw ◽  
Catherine Quinlan

International guidelines in peritoneal dialysis (PD) advocate for regular application of topical mupirocin in chronic PD exit-site care. A strong evidence base links this treatment to reduced rates of exit-site infections and peritonitis. However, emerging reports of increasing mupirocin resistance and gram-negative infections are threatening the long-term viability of topical antibiotic ointments as a prophylactic treatment. Medical grade honey has multiple proven antibacterial and wound healing properties. High-quality randomized controlled trial evidence (the HONEYPOT trial), however, does not support the use of topical medical-grade honey over antibiotic ointments for the prevention of exit-site infection and peritonitis in adults. Pediatric representation in these studies is low, and these findings may not extrapolate to the pediatric context, which has a higher incidence of PD-related infection and a lower prevalence of diabetes.We present a series of 8 pediatric patients treated with topical Medihoney (Comvita, Paengaroa, New Zealand) in the context of poor exit-site condition, persistent infection, and recurrent granuloma where the addition of honey was felt to produce remarkable improvement in exit-site status.Medihoney is the first-line prophylactic exit-site ointment in PD exit sites at our institution and has been implicated in the salvage of peritoneal access in some patients. No exclusively pediatric studies have been performed; however, existing literature suggests a beneficial effect in promoting healing of infected wounds with a lower risk of developing antimicrobial resistance.


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