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IntroductionAround 30% of peripherally inserted central catheters (PICCs) fail from vascular, infectious or mechanical complications. Patients with cancer are at highest risk, and this increases morbidity, mortality and costs. Effective PICC dressing and securement may prevent PICC failure; however, no large randomised controlled trial (RCT) has compared alternative approaches. We designed this RCT to assess the clinical and cost-effectiveness of dressing and securements to prevent PICC failure.Methods and analysisPragmatic, multicentre, 2×2 factorial, superiority RCT of (1) dressings (chlorhexidine gluconate disc (CHG) vs no disc) and (2) securements (integrated securement dressing (ISD) vs securement device (SED)). A qualitative evaluation using a knowledge translation framework is included. Recruitment of 1240 patients will occur over 3 years with allocation concealment until randomisation by a centralised service. For the dressing hypothesis, we hypothesise CHG discs will reduce catheter-associated bloodstream infection (CABSI) compared with no CHG disc. For the securement hypothesis, we hypothesise that ISD will reduce composite PICC failure (infection (CABSI/local infection), occlusion, dislodgement or thrombosis), compared with SED. Secondary outcomes: types of PICC failure; safety; costs; dressing/securement failure; dwell time; microbial colonisation; reversible PICC complications and consumer acceptability. Relative incidence rates of CABSI and PICC failure/100 devices and/1000 PICC days (with 95% CIs) will summarise treatment impact. Kaplan-Meier survival curves (and log rank Mantel-Haenszel test) will compare outcomes over time. Secondary end points will be compared between groups using parametric/non-parametric techniques; p values <0.05 will be considered to be statistically significant.Ethics and disseminationEthical approval from Queensland Health (HREC/15/QRCH/241) and Griffith University (Ref. No. 2016/063). Results will be published.Trial registrationTrial registration number is: ACTRN12616000315415.

BackgroundThe need to gown for labor epidural catheter insertion is controversial. The American Society of Regional Anesthesia and Pain Medicine has identified a lack of randomized controlled trials investigating this issue. The purpose of this study was to examine the effect of gowning on colonization rates following epidural catheter insertion for labor analgesia.MethodsFollowing research ethics board approval and informed written consent, parturients were randomized to undergo epidural analgesia with the anesthesiologist either ungowned or wearing a sterile gown. Cultures were obtained from each of the operator forearms, the work area under the insertion site, and from the epidural catheter tip as well as from the catheter segment adjacent to the insertion site. The primary outcome was growth of any microbial organisms from the cultured sites.ResultsTwo hundred fourteen patients completed the study. There were no significant differences in catheter-tip colonization rates between the ungowned and gowned groups (9.2% vs 7.6%, respectively). The most common microorganism that was cultured was coagulase-negative Staphylococcus.ConclusionsThe use of gowns in the current study did not affect catheter colonization rate. Overall, there was a relatively high incidence of catheter-tip colonization in both groups, which underscores the need for strict aseptic technique.

Background Tunnelled central venous dialysis catheter use is significantly limited by the occurrence of catheter-related infections. This randomised controlled trial assessed the efficacy of a 48 hour 70% ethanol lock vs heparin locks in prolonging the time to the first episode of catheter related blood stream infection (CRBSI). Methods Patients undergoing haemodialysis (HD) via a tunnelled catheter were randomised 1:1 to once per week ethanol locks (with two heparin locks between other dialysis sessions) vs thrice per week heparin locks. Results Observed catheter days in the heparin (n=24) and ethanol (n=25) groups were 1814 and 3614 respectively. CRBSI occurred at a rate of 0.85 vs. 0.28 per 1000 catheter days in the heparin vs ethanol group by intention to treat analysis (incident rate ratio (IRR) for ethanol vs. heparin 0.17; 95%CI 0.02-1.63; p=0.12). Flow issues requiring catheter removal occurred at a rate of 1.6 vs 1.4 per 1000 catheter days in the heparin and ethanol groups respectively (IRR 0.85; 95% CI 0.20-3.5 p =0.82 (for ethanol vs heparin). Conclusions Catheter survival and catheter-related blood stream infection were not significantly different but there was a trend towards a reduced rate of infection in the ethanol group. This study establishes proof of concept and will inform an adequately powered multicentre trial to definitively examine the efficacy and safety of ethanol locks as an alternative to current therapies used in the prevention of catheter-associated blood stream infections in patients dialysing with tunnelled catheters. Trial Registration Australian New Zealand Clinical Trials Registry ACTRN12609000493246

BackgroundIn recent years, cranial ventricular catheters impregnated with antimicrobial agents have become available. Theoretically, they provide antibiotic prophylaxis locally without the associated complications of opportunistic nosocomial infections. This study aims to compare antibiotic impregnated catheters with conventional catheters coupled with systemic antibiotics.MethodsPatients undergoing emergency neurosurgical operations were recruited. Patients were randomly assigned to antibiotic impregnated catheters (Bactiseal, Codman, Johnson & Johnson, Raynham, MA, USA) or conventional catheters coupled with systemic antibiotics.Results184 neurosurgical patients were enrolled between April 2004 and December 2008. Mean duration of ventricular catheter was 10 days for both groups. The proportion of patients with nosocomial infection was not significantly different: 57% (51/90) in the Bactiseal group and 51% (48/94) in the conventional group (OR 1.3, 0.7 to 2.2). There were also no differences in secondary outcome measures (CSF infection, intensive care unit stay, acute hospital stay and functional outcome) between the two groups.ConclusionsAntibiotic impregnated catheters are as effective as systemic antibiotics in the prevention of CSF infection and their corresponding nosocomial infection rates are not significantly different.The study is registered at http://www.ClinicalTrials.gov (NCT00286104).

Purpose Plants extracts are used in urology to manage urinary tract infections. We aimed to evaluate the efficacy of a preparation with solidago, orthosiphon, birch and cranberry extracts (CISTIMEV PLUS ® ) in reducing microbial colonization and biofilm development in patients with indwelling urinary catheters. Methods All consecutive outpatients attending our department between January and June 2010 for the substitution of indwelling catheters were considered for this single-blinded, randomized and controlled pilot study to test superiority of the preventative management (CISTIMEV PLUS ® , 1 tablet daily for 30 days) in respect to no treatment. A sample size of 10–40 participants per group was considered adequate. All patients underwent urine culture the same day of the catheter substitution and were then randomized into test group ( n  = 48) and control group ( n  = 35). Ultrastructural analysis was also performed. After 30 days, the catheter was replaced and the analysis repeated. The primary outcome was the rate of positive urinary culture at the end of the entire study period. Results Ten patients abandoned the study. At 30 days, according to per-protocol analysis, the groups statistically differed regarding the rate of positive urine cultures: test group 10/43 and control group 16/30 ( p  = 0.013) (−30.1 % [95 % CI −51.94 to −8.21]). The most common isolated bacteria were Escherichia coli and Enterococcus faecalis. Conclusions The use of solidago, orthosiphon, birch and cranberry extracts resulted in a significant reduction of microbial colonization in patients with indwelling urinary catheters. Larger clinical trials are needed to demonstrate that the effects here reported are sufficient to reduce symptomatic catheter-associated urinary tract infections.

Introduction Catheter-associated infection of cerebrospinal fluid (CSF) is a potentially life-threatening complication of external ventricular drainage (EVD). The purpose of this pilot study was to address the efficacy of silver-impregnated EVD catheters in neurological and neurosurgical patients requiring external CSF drainage due to acute occlusive hydrocephalus. Methods Nineteen consecutive patients were enrolled in the treatment arm of the study and data were prospectively recorded for these patients. The control group consisted of 20 patients for whom data were retrospectively assessed. CSF samples were drawn at least three times a week and routine bacterial cultures and CSF analyses were done according to standard protocols. The primary endpoint of the study was the occurrence of catheter-associated ventriculitis (CAV) proven by positive CSF culture. Secondary endpoints were bacterial colonization of the catheter tip and CSF pleocytosis. Results In 20 control patients, 5 CAVs were microbiologically diagnosed. In contrast, no positive CSF cultures were found in the treatment group. This difference was statistically significant ( P  < 0.05). All CAVs occurred later than day 10 after catheter placement. Colonization of the catheter tip was found in 6 patients in the control group and in 5 patients in the treatment group (not significant). Conclusions This pilot study indicates that EVD catheters impregnated with silver nanoparticles might be a new option for preventing CAV in neurocritical care patients, and therefore evaluation in a large prospective randomized study is warranted.

External ventricular drains (EVDs) are valuable adjuncts in the management of neurosurgical patients but are associated with a significant risk of cerebrospinal fluid (CSF) infection (range, 0% to 27%); a review of 23 studies reported a mean of 8.8%. To compare the efficacy of 2 different antibiotic-impregnated EVD catheters in preventing CSF infections. Patients were prospectively enrolled in an Institutional Review Board-approved study. During alternating 3-month periods, all patients received either a minocycline/rifampin-impregnated (M/R) ventricular catheter or a clindamycin/rifampin-impregnated (C/R) EVD catheter. CSF cultures were collected at the time of insertion and twice weekly. Positive cultures were defined a priori as growth of the same bacteria on 2 media (eg, blood agar and broth) or 2 cultures of the same bacteria on 1 medium (eg, broth). Altogether, 129 patients (mean age, 58.4 years; 55 male) received 65 C/R catheters and 64 M/R catheters. The most common indications for EVD placement were aneurysmal subarachnoid hemorrhage (48.1%), spontaneous intraparenchymal hemorrhage (13.2%), and tumor (11.6%). The mean duration of ventriculostomy drainage was 11.8 and 12.7 days in the C/R and M/R groups, respectively. No positive CSF cultures were identified in either cohort. The use of antibiotic-impregnated catheters was associated with an extremely low risk of CSF infection compared with the reported mean of nearly 9% for standard EVD catheters. Infection rates for both C/R and M/R EVD catheters were zero. These results support the use of antibiotic-impregnated EVD catheters in routine clinical practice.

Background Infections are common complications of neonatal long lines. Heparin has been shown to prolong the effective duration of neonatal long lines and to reduce the ability of bacteria to adhere to foreign surfaces, but the effect of heparin on rates of infection is uncertain. Objective The goal of this study was to evaluate the effect of heparin on the frequency of episodes of catheter-related sepsis (CRS) in infants receiving total parenteral nutrition (TPN) through a neonatal long line. Design/Methods This randomised, controlled, double blind, single-centre clinical trial compared heparin at 0.5 IU/ml with no heparin in TPN infused through a neonatal long line, with episodes of CRS as the primary outcome. Results 210 infants were enrolled (TPN with heparin n=102, TPN without heparin n=108). There was a statistically significant reduction in all episodes of culture-positive CRS in those infants with heparin added to the TPN compared with those without heparin (p=0.04; RR 0.57, 95% CI 0.32 to 0.98; number needed to treat 9, 95% CI 4.6 to 212.4). Conclusions The addition of heparin at 0.5 IU/ml to TPN infused through a neonatal long line reduces the incidence of culture-positive CRS.

Background: It is controversial whether regular changes of external ventricular drains can reduce cerebrospinal fluid (CSF) infection. Objective: To carry out a randomised controlled clinical trial over a two year period to determine whether a regular change of ventricular catheter every five days could reduce CSF infection and improve outcome. Methods: 103 patients requiring external ventricular drains for more than five days and with no evidence of concurrent CSF infection were studied. The patients were randomised to regular change of ventricular catheter (every five days) and no change unless clinically indicated. Results: The CSF infection rates were 7.8% for the catheter change group and 3.8% for the no change group, respectively (rate ratio = 1.80, 95% confidence interval 0.33 to 9.81, p = 0.50). No significant difference was found in intensive care unit stay, ward stay, or clinical outcome between the two groups. Conclusions: Regular changes of ventricular catheter at five day intervals did not reduce the risk of CSF infection. A single external ventricular drain can be employed for as long as clinically indicated.

Background. Oral combination therapy with fluoroquinolones plus rifampicin is a promising alternative to standard parenteral therapy for staphylococcal infections. Methods. In a multicenter, randomized trial, we compared the efficacy, safety, and length of hospital stay for patients with staphylococcal infections treated either with an oral combination of a fluoroquinolone (fleroxacin) plus rifampicin or with standard parenteral treatment (flucloxacillin or vancomycin). Patients were included if cultures showed the presence of bacteremia or deep-seated infections with Staphylococcus aureus (104 patients) or catheter-related bacteremia due to drug-susceptible, coagulase-negative staphylococci (23 patients). Results. The cure rate in the intention-to-treat analysis was 78% for the fleroxacin-rifampicin group (68 patients) and 75% for the standard therapy group (59 patients; 47 received flucloxacillin, and 12 received vancomycin); in the population of clinically evaluable patients (n = 119), the cure rate was 82% and 80%, respectively; and in the population of microbiologically evaluable patients (n = 103), the cure rate was 86% and 84%, respectively. Clinical and bacteriological failures after S. aureus infections were documented in similar proportions of patients. The median length of hospital stay after study entry was 12 days in the fleroxacin-rifampicin group, compared with 23 days in the standard treatment group (P = .006). More adverse events probably related to the study drug were reported in the fleroxacin-rifampicin group than in the standard therapy group (15 of 68 vs. 5 of 59 patients; P = .05). Conclusions. This study suggests that an oral regimen containing a fluoroquinolone plus rifampicin may be effective for treating staphylococcal infections, allowing earlier discharge from the hospital.