Early versus late onset bloodstream infection during neutropenia after high-dose chemotherapy for hematologic malignancy.

PURPOSE: The length of neutropenia has a significant impact on the incidence of bloodstream infection (BSI) in cancer patients, but limited information is available about the pathogen distribution in late BSI. METHODS: Between 2002 and 2014, BSI episodes in patients with neutropenia receiving chemotherapy for hematologic malignancies were prospectively identified by multicenter, active surveillance in Germany, Switzerland and Austria. The incidence of first BSI episodes, their microbiology and time to BSI onset during the first episode of neutropenia of 15,988 patients are described. RESULTS: The incidence rate of BSI episodes was 14.7, 8.7, and 4.7 per 1000 patient-days in the first, second, and third week of neutropenia, respectively. BSI developed after a median of 5 days of neutropenia (interquartile range [IQR] 3-10 days). The medium duration of neutropenia to BSI onset was 4 days in Escherichia coli (IQR 3-7 days), Klebsiella spp. (2-8 days), and Staphylococcus aureus (3-6 days). In contrast, BSI due to Enterococcus faecium occurred after a median of 9 days (IQR 6-14 days; p < 0.001 vs. other BSI). Late onset of BSI (occurring after the first week of neutropenia) was also observed for Stenotrophomonas maltophilia (12 days, IQR 7-17 days; p < 0.001), and non-albicans Candida spp. (13 days, IQR 8-19 days; p < 0.001). CONCLUSIONS: Over the course of neutropenia, the proportion of difficult to treat pathogens such as E. faecium, S. maltophilia, and Candida spp. increased. Among other factors, prior duration of neutropenia may help to guide empiric antimicrobial treatment in febrile neutropenia.

Contribution of specific pathogens to bloodstream infection mortality in neutropenic patients with hematologic malignancies: Results from a multicentric surveillance cohort study.

Bloodstream infection (BSI) remains a serious complication in patients with hematologic malignancies and neutropenia. The risk factors for mortality after BSI and the contributions of BSI pathogens to mortality remain incompletely understood. We evaluated first BSI among adult neutropenic patients undergoing high-dose chemotherapy for hematologic malignancies in the setting of (a) an early disease stage of autologous (auto-HSCT) or allogeneic (allo-HSCT) hematopoietic stem cell transplantation or (b) for acute leukemia. Risk factors for intensive care admission and all-cause mortality were analyzed by multivariable logistic regression 7 and 30 days after onset of the first BSI in the first neutropenic episode. Between 2002 and 2015, 9080 patients met the study inclusion criteria, and 1424 (16%) developed BSIs, most of them during the first week of neutropenia. Mortality during neutropenia within 7 days and 30 days after BSI onset was 2.5% and 5.1%, respectively, and differed considerably between BSI pathogens. Both 7-day and 30-day mortalities were highest for Pseudomonas aeruginosa BSI (16.7% and 26.7%, respectively) and lowest for BSI due to coagulase-negative Staphylococcus spp. (CoNS) and Streptococcus spp. BSI pathogens were independently associated with 7-day mortality included P aeruginosa, Klebsiella spp., Enterobacter spp., Serratia spp., and enterococci. Only gram-negative BSI and candidemia were associated with admission to intensive care within 7 days after BSI onset. BSI caused by P aeruginosa continues to carry a particularly poor prognosis in neutropenic patients. The unexpected association between enterococcal BSI and increased mortality needs further study.

Costs of hospital-acquired Clostridium difficile infections: an analysis on the effect of time-dependent exposures using routine and surveillance data.

BACKGROUND: Hospital-acquired infections have not only gained increasing attention clinically, but also methodologically, as a time-varying exposure. While methods to appropriately estimate extra length of stay (LOS) have been established and are increasingly used in the literature, proper estimation of cost figures has lagged behind. METHODS: Analysing the additional costs and reimbursements of Clostridium difficile-infections (CDI), we use a within-main-diagnosis-time-to-exposure stratification approach to incorporate time-varying exposures in a regression model, while at the same time accounting for cost clustering within diagnosis groups. RESULTS: We find that CDI is associated with €9000 of extra costs, €7800 of higher reimbursements, and 6.4 days extra length of stay. Using a conventional method, which suffers from time-dependent bias, we derive estimates more than three times as high (€23,000, €8000, 21 days respectively). We discuss our method in the context of recent methodological advances in the estimation of the costs of hospital-acquired infections. CONCLUSIONS: CDI is associated with sizeable in-hospital costs. Neglecting the methodological particularities of hospital-acquired infections can however substantially bias results. As the data needed for an appropriate analysis are collected routinely in most hospitals, we recommend our approach as a feasible way for estimating the economic impact of time-varying adverse events during hospital stay.

Key priorities in the prevention and control of healthcare-associated infection: a survey of European and other international infection prevention experts.

PURPOSE: Prevention and control of healthcare-associated infection (HCAI) are important within and beyond Europe. However, it is unclear which areas are considered important by HCAI prevention and control professionals. This study assesses the priorities in the prevention and control of HCAI as judged by experts in the field. METHODS: A survey was conducted by the European Society of Clinical Microbiology and Infectious Diseases focussing on seven topics using SurveyMonkey®. Through a newsletter distributed by email, about 5000 individuals were targeted throughout the world in February and March 2013. Participants were asked to rate the importance of particular topics from one (low importance) to ten (extraordinary importance), and there was no restriction on giving equal importance to more than one topic. RESULTS: A total of 589 experts from 86 countries participated including 462 from Europe (response rate: 11.8 %). Physicians accounted for 60 % of participants, and 57 % had ten or more years' experience in this area. Microbial epidemiology/resistance achieved the highest priority scoring with 8.9, followed by surveillance 8.2, and decolonisation/disinfection/antiseptics with 7.9. Under epidemiology/resistance, highly resistant Gram-negative bacilli scored highest (9.0-9.2). The provision of computerised healthcare information systems for the early detection of outbreaks was accorded the top priority under surveillance. The prevention of surgical site and central line infections ranked highest under the category of specific HCAI and HCAI in certain settings. Differences between regions are described. CONCLUSION: These findings reflect the concerns of experts in HCAI prevention and control. The results from this survey should inform national and international agencies on future action and research priorities.

Bacterial Contamination of the Anesthesia Workplace and Efficiency of Routine Cleaning Procedures: A Prospective Cohort Study.

In this prospective cohort study, 200 decontamination (cleaning and disinfection) procedures of the anesthesia workplace either by anesthesia nurses or by specially trained housekeeping staff were monitored. Time used by housekeeping staff was shorter (1.2 ± 0.1 vs 2.6 ± 0.2 minutes on average, data are mean ± SEM; P < 0.0001) with less visible marker spots (14.4 ± 0.68 [55%] vs 17.3 ± 0.75 [66.7%] on average, data are mean ± SEM; P = 0.0041), and the bacterial load showed a decrease (≅67%, P < 0.0001) compared with anesthesia nurses. Specially trained housekeeping staff outperformed anesthesia nurses in cleaning the anesthesia workplace. Specific training for anesthesia workplace cleaning is supported by these findings.

Correlation between Overconfidence and Learning Motivation in Postgraduate Infection Prevention and Control Training.

Introduction: Training in hand hygiene for health care workers is essential to reduce hospital-acquired infections. Unfortunately, training in this competency may be perceived as tedious, time-consuming, and expendable. In preceding studies, our working group detected overconfidence effects in the self-assessment of hand hygiene competencies. Overconfidence is the belief of being better than others (overplacement) or being better than tests reveal (overestimation). The belief that members of their profession are better than other professionals is attributable to the clinical tribalism phenomenon. The study aimed to assess the correlation of overconfidence effects on hand hygiene and their association with four motivational dimensions (intrinsic, identified, external, and amotivation) to attend hand hygiene training. Methods: We conducted an open online convenience sampling survey with 103 health care professionals (physicians, nurses, and paramedics) in German, combining previously validated questionnaires for (a) overconfidence in hand hygiene and (b) learning motivation assessments. Statistics included parametric, nonparametric, and cluster analyses. Results: We detected a quadratic, u-shaped correlation between learning motivation and the assessments of one's own and others' competencies. The results of the quadratic regressions with overplacement and its quadratic term as predictors indicated that the model explained 7% of the variance of amotivation (R2 = 0.07; F(2, 100) = 3.94; p = 0.02). Similarly, the quadratic model of clinical tribalism for nurses in comparison to physicians and its quadratic term explained 18% of the variance of amotivation (R2 = 0.18; F(2, 48) = 5.30; p = 0.01). Cluster analysis revealed three distinct groups of participants: (1) "experts" (n1 = 43) with excellent knowledge and justifiable confidence in their proficiencies but still motivated for ongoing training, and (2) "recruitables" (n2 = 43) who are less competent with mild overconfidence and higher motivation to attend training, and (3) "unawares" (n3 = 17) being highly overconfident, incompetent (especially in assessing risks for incorrect and omitted hand hygiene), and lacking motivation for training. Discussion: We were able to show that a highly rated self-assessment, which was justified (confident) or unjustified (overconfident), does not necessarily correlate with a low motivation to learn. However, the expert's learning motivation stayed high. Overconfident persons could be divided into two groups: motivated for training (recruitable) or not (unaware). These findings are consistent with prior studies on overconfidence in medical and non-medical contexts. Regarding the study's limitations (sample size and convenience sampling), our findings indicate a need for further research in the closed populations of health care providers on training motivation in hand hygiene.

Interprofessional perceptions of emotional, social, and ethical effects of multidrug-resistant organisms: A qualitative study.

INTRODUCTION: Multi-drug-resistant organisms (MDRO) are usually managed by separating the infected patients to protect others from colonization and infection. Isolation precautions are associated with negative experiences by patients and their relatives, while hospital staff experience a heavier workload and their own emotional reactions. METHODS: In 2018, 35 participants (nurses, physicians, pharmacists) in an antimicrobial-stewardship program participated in facilitated discussion groups working on the emotional impact of MDRO. Deductive codings were done by four coders focusing on the five basic emotions described by Paul Ekmans. RESULTS: All five emotions revealed four to 11 codes forming several subthemes: Anger is expressed because of incompetence, workflow-impairment and lack of knowledge. Anxiety is provoked by inadequate knowledge, guilt, isolation, bad prognoses, and media-related effects. Enjoyment is seldom. Sadness is experienced in terms of helplessness and second-victim effects. Disgust is attributed to shame and bad associations, but on the other hand MDROs seem to be part of everyday life. Deductive coding yielded additional codes for bioethics and the Calgary Family Assessment Method. CONCLUSION: MDRO are perceived to have severe impact on emotions and may affect bioethical and family psychological issues. Thus, further work should concentrate on these findings to generate a holistic view of MDRO on human life and social systems.

Incidence densities in a competing events analysis.

Epidemiologists often study the incidence density (ID; also known as incidence rate), which is the number of observed events divided by population-time at risk. Its computational simplicity makes it attractive in applications, but a common concern is that the ID is misleading if the underlying hazard is not constant in time. Another difficulty arises if competing events are present, which seems to have attracted less attention in the literature. However, there are situations in which the presence of competing events obscures the analysis more than nonconstant hazards do. The authors illustrate such a situation using data on infectious complications in patients receiving stem cell transplants, showing that a certain transplant type reduces the infection ID but eventually increases the cumulative infection probability because of its effect on the competing event. The authors investigate the extent to which IDs allow for a reasonable analysis of competing events. They suggest a simple multistate-type graphic based on IDs, which immediately displays the competing event situation. The authors also suggest a more formal summary analysis in terms of a best approximating effect on the cumulative event probability, considering another data example of US women infected with human immunodeficiency virus. Competing events and even more complex event patterns may be adequately addressed with the suggested methodology.

Central venous catheter-associated bloodstream infection and colonisation of insertion site and catheter tip. What are the rates and risk factors in haematology patients?

Skin colonisation is an important source for central venous catheter (CVC) colonisation and infection. This study intended to identify risk factors for skin colonisation prior to CVC placement (baseline colonisation) and within 10 days after CVC insertion (subsequent colonisation), for CVC-tip colonisation and for bloodstream infection (BSI). Within a randomised clinical trial, data of 219 patients with haematological malignancies and inserted CVC (with a total of 5,501 CVC-days and 4,275 days at risk) in two university hospitals were analysed. Quantitative skin cultures were obtained from the insertion site before CVC placement and at regular intervals afterwards. CVC-tip cultures were taken on CVC removal and data collection was performed. Statistical analysis included linear and logistic regression models. Age was an independent risk factor for colonisation prior to CVC placement (baseline colonisation). Independent risk factors for subsequent colonisation were baseline colonisation and male gender. High level of subsequent skin colonisation at the insertion site was a predictor of CVC-tip colonisation, and a predictor of BSI. High level of skin colonisation predicts catheter tip colonisation and possibly subsequent infection. Sustained reduction of bacterial growth at the CVC insertion site is therefore indispensable. Male patients are at particular risk for skin colonisation and may be a target population for additional insertion-site care before and during catheterisation.

Speaking up behavior and cognitive bias in hand hygiene: Competences of German-speaking medical students.

INTRODUCTION: Infection prevention and speaking up on errors are core qualities of health care providers. Heuristic effects (e.g. overconfidence) may impair behavior in daily routine, while speaking up can be inhibited by hierarchical barriers and medical team factors. Aim of this investigation was to determine, how medical students experience these difficulties for hand hygiene in daily routine. METHODS: On the base of prior investigations we developed a questionnaire with 5-point Likert ordinal scaled items and free text entries. This was tested for validity and reliability (Cronbach's Alpha 0.89). Accredited German, Swiss and Austrian universities were contacted and medical students asked to participated in the anonymous online survey. Quantitative statistics used parametric and non-parametric tests and effect size calculations according to Lakens. Qualitative data was coded according to Janesick. RESULTS: 1042 undergraduates of 12 universities participated. All rated their capabilities in hand hygiene and feedback reception higher than those of fellow students, nurses and physicians (p<0.001). Half of the participants rating themselves to be best educated, realized that faulty hand hygiene can be of lethal effect. Findings were independent from age, sex, academic course and university. Speaking-up in case of omitted hand hygiene was rated to be done seldomly and most rare on persons of higher hierarchic levels. Qualitative results of 164 entries showed four main themes: 1) Education methods in hand hygiene are insufficient, 2) Hierarchy barriers impair constructive work place culture 3) Hygiene and feedback are linked to medical ethics and 4) There is no consequence for breaking hygiene rules. DISCUSSION: Although partially limited by the selection bias, this study confirms the overconfidence-effects demonstrated in post-graduates in other settings and different professions. The independence from study progress suggests, that the effect occurs before start of the academic course with need for educational intervention at the very beginning. Qualitative data showed that used methods are insufficient and contradictory work place behavior in hospitals are frustrating. Even 20 years after "To err is human", work place culture still is far away from the desirable.

Interprofessional perceptions and emotional impact of multidrug-resistant organisms: A qualitative study.

BACKGROUND: Hospital-acquired infections caused by multidrug-resistant organisms (MDROs) are a threat to patient safety and hospital economy. Training in hygiene precautions is known to limit MDRO spread and patient morbidity. As infection prevention is a collaborative task, we developed an interprofessional educational intervention, including a reflective unit about MDRO. This article reports on the perceptions of professionals for MDRO management. METHODS: In 2017, we conducted 8 trainings, including facilitated group discussions focusing on the question how participants think others experience MDRO. Results were analyzed using a socio-constructivist qualitative approach. RESULTS: A total of 51 health care workers from 13 professions and 5 hospitals participated, generating 366 items for coding. Three main themes could be identified: (1) significant barriers in educating clinicians and informing lay persons, (2) emotional reactions-especially anxiety and anger-from the perspective of lay persons and professionals evoked by MDRO, and (3) perceived economic burden. CONCLUSIONS: MDROs generate psychosocial side effects with an impact on health care management and on professional-patient relationships and interprofessional relationships. Specifically, emotions evoked by insufficient information and transparency play a major role. Therefore, hygiene trainings must not be limited to basic skills. In addition, they should be comprised of communication and educational techniques and evoke attentiveness for emotional stress.

Overconfidence in infection control proficiency.

BACKGROUND: Infection control partially depends on hygiene and communication skills. Unfortunately, motivation for continuous training is lower than desired. Many health care providers (HCPs) do not recognize the need for training but express this need for others. This is attributable to heuristic errors, such as the overconfidence effect. The aim of this study was to quantify the flawed self-assessment in infection-control. METHODS: In this cross-sectional multicenter study, 255 HCPs of different specialties participated in the 29-item, 5-point Likert scale questionnaire, assessing perceived proficiency in hand hygiene and communication skills for both themselves and others (colleagues, trainees, and supervisors of their own specialty and HCPs of others). RESULTS: 222 of 255 surveys could be analyzed. Respondents rated themselves to be better trained in handhygiene (P < .001) than trainees, colleagues, and supervisors; the same was seen for feedback skills (P < .001). HCPs of other specialties were consistently rated worse in all aspects (P < .001). CONCLUSION: Results show an overplacement effect in infection prevention skills. The belief of being well educated creates a subjective conviction that no further education in hand hygiene is needed. Thus, HCPs may face motivation barriers that require specialized programs to overcome these beliefs.

Cognitive bias in professional hand hygiene and feedback: A national online-survey on overconfidence in Germany.

To evaluate learning motivation barriers in infection control and feedback competences, we conducted a national online survey in Germany. Among 767 healthcare workers, overconfidence effects could be detected independent from age, gender, profession, education, and hospital-size. The identified effects may impair learning motivation relevant for supervisors and educators in infection control.

Ten years of KISS: the most important requirements for success.

Ten years ago, in January 1997, data collection for the German national nosocomial infection surveillance system was established, which is known by the acronym KISS (Krankenhaus-Infektions-Surveillance-System). Meanwhile KISS was able to demonstrate a beneficial effect from ongoing surveillance activities and appropriate feedback to the users in combination with reference data for ventilator associated pneumonia, primary bloodstream infections and surgical site infections. Significant reductions of infection rates between 20-30% over 3 years periods in the components for intensive care units, operative departments and neonatal intensive care units were demonstrated. Due to our experience the following requirements have to be fulfilled to keep a surveillance system successful over longer periods: close contact between the participating institutions, consideration of new developments, timely regular data feedback and constant reevaluation of the way of data presentation, data validity and demonstration of its contribution to the reduction of healthcare associated infections (HAI). The article describes in more detail how KISS tries to fulfill these requirements.

Variability in contact precautions to control the nosocomial spread of multi-drug resistant organisms in the endemic setting: a multinational cross-sectional survey.

Background: Definitions and practices regarding use of contact precautions and isolation to prevent the spread of gram-positive and gram-negative multidrug-resistant organisms (MDRO) are not uniform. Methods: We conducted an on-site survey during the European Congress on Clinical Microbiology and Infectious Diseases 2014 to assess specific details on contact precaution and implementation barriers. Results: Attendants from 32 European (EU) and 24 non-EU countries participated (n = 213). In EU-respondents adherence to contact precautions and isolation was high for Methicillin-resistant Staphylococcus aureus (MRSA), carbapenem-resistant Enterobacteriaceae, and MDR A. baumannii (84.7, 85.7, and 80%, respectively) whereas only 68% of EU-respondents considered any contact precaution measures for extended-spectrum-beta-lactamase (ESBL) producing non-E. coli. Between 30 and 45% of all EU and non-EU respondents did not require health-care workers (HCW) to wear gowns and gloves at all times when entering the room of a patient in contact isolation. Between 10 and 20% of respondents did not consider any rooming specifications or isolation for gram-positive MDRO and up to 30% of respondents abstain from such interventions in gram-negative MDRO, especially non-E. coli ESBL. Understaffing and lack of sufficient isolation rooms were the most commonly encountered barriers amongst EU and non-EU respondents. Conclusion: The effectiveness of contact precautions and isolation is difficult to assess due to great variation in components of the specific measures and mixed levels of implementation. The lack of uniform positive effects of contact isolation to prevent transmission may be explained by the variability of interpretation of this term. Indications for contact isolation require a global definition and further sound studies.

Impact of fluoroquinolone prophylaxis during neutropenia on bloodstream infection: Data from a surveillance program in 8755 patients receiving high-dose chemotherapy for haematologic malignancies between 2009 and 2014.

OBJECTIVES: Antibacterial chemoprophylaxis with fluoroquinolones (FQPx) has been commonly used in cancer patients with neutropenia, but its efficacy has been challenged by the emergence of fluoroquinolone resistance. METHODS: The impact of FQPx on bloodstream infections (BSI) during neutropenia after high-dose chemotherapy for haematologic malignancies was evaluated through a multicenter hospital infection surveillance system for the period 2009-2014. RESULTS: Among 8755 patients (4223 allogeneic [allo-] HSCT, 3602 autologous [auto-] HSCT, 930 high-dose chemotherapy for acute leukemia [HDC]), 5302 (61%) had received FQPx. Administration of FQPx was associated with fewer Gram-negative BSI in the overall study cohort patients (4.6% vs. 7.7%, adjusted subdistribution hazard ratio [aSHR] 0.59, 95%CI 0.50-0.70), in patients with HDC (3.7% vs. 9.2%, adjusted subdistribution hazard ratio [aSHR] 0.40, 95%CI 0.22-0.70) and auto-HSCT patients (4% vs. 9%, aSHR 0.43, 95%CI 0.33-0.56). In HDC patients, FQPx was associated with a marked reduction in all-cause mortality during neutropenia (2.3% vs. 7.8%, aSHR 0.30, 95%CI 0.15-0.58). Patients receiving FQPx had significantly more BSIs due to ESBL-positive Enterobacteriacea (0.8 vs. 0.3%, RR 2.2, 95%CI 1.17-4.26). BSIs by MRSA (n = 5) and VRE (n = 11) were rare in our cohort. CONCLUSIONS: As used in the participating centers, FQPx was associated with reduced Gram-negative BSI and improved survival among HDC patients. Among HSCT patients, the benefits were less clear. If adapted to local resistance patterns and patient characteristics, FQPx still may be useful in the management of patients with haematologic malignancies.

Microbial Load in Septic and Aseptic Procedure Rooms.

BACKGROUND: Highly effective measures to prevent surgical wound infections have been established over the last two decades. We studied whether the strict separation of septic and aseptic procedure rooms is still necessary. METHODS: In an exploratory, prospective observational study, the microbial concentration in an operating room without a room ventilating system (RVS) was analyzed during 16 septic and 14 aseptic operations with the aid of an air sampler (50 cm and 1 m from the operative field) and sedimentation plates (1 m from the operative field, and contact culture on the walls). The means and standard deviations of the microbial loads were compared with the aid of GEE models (generalized estimation equations). RESULTS: In the comparison of septic and aseptic operations, no relevant differences were found with respect to the overall microbial concentration in the room air (401.7 ± 176.3 versus 388.2 ± 178.3 CFU/m3; p = 0.692 [CFU, colony-forming units]) or sedimentation 1 m from the operative field (45.3 ± 22.0 versus 48.7 ± 18.5 CFU/m2/min; p = 0.603) and on the walls (35.7 ± 43.7 versus 29.0 ± 49.4 CFU/m2/min; p = 0.685). The only relevant differences between the microbial spectra associated with the two types of procedure were a small amount of sedimentation of Escherichia coli and Enterococcus faecalis in septic operations, and of staphylococcus aureus and pseudomonas stutzeri in aseptic operations, up to 30 minutes after the end of the procedure. CONCLUSION: These data do not suggest that septic and aseptic procedure rooms need to be separated. In interpreting the findings, one should recall that the study was not planned as an equivalence or non-inferiority study. Wherever patient safety is concerned, high-level safety concepts should only be demoted to lower levels if new and convincing evidence becomes available.

AMBU-KISS: quality control in ambulatory surgery.

BACKGROUND: Cost-containment measures have led to a constant increase in the number of patients cared for as outpatients. Several studies have demonstrated that surgical site infections result in considerable morbidity and excess health care costs from extended duration of hospitalization and antibiotic use. OBJECTIVE: AMBU-KISS is a protocol designed to create a reference database on surgical site infections for institutions involved in ambulatory surgery. METHODS: This study was carried out using a physician questionnaire. We compared surgical site infection rates for 3 indicator procedures in the ambulatory setting to those observed in the inpatient setting. The 3 indicator procedures chosen for the protocol were arthroscopic knee surgery and inguinal hernia and vein-stripping procedures. RESULTS: The arithmetic mean values of surgical site infection rates in arthroscopic surgery of the knee are 0.09% in the ambulatory setting and 0.11% in the hospital setting. For inguinal hernias, the respective rates are 0.65% and 0.78%. These differences, however, did not reach statistical significance (arthroscopic surgery, P = .8323 and inguinal herniotomies, P = .4895). A marked difference was observed for vein-stripping procedures, with surgical site infection rates of 0.38% in the ambulatory setting and 0.64% in the hospital setting. However, this difference was also not statistically significant, P = .1556. CONCLUSION: The AMBU-KISS protocol appears to be suitable for assessing and defining the magnitude of surgical site infections in ambulatory surgery. The preliminary results of our study show no significant differences for the 3 indicator procedures.

Safety and tolerability of virucidal hand rubs: a randomized, double-blind, cross-over trial with healthy volunteers.

BACKGROUND: The hands of the medical staff play an important role in transmission of pathogens in the health care environment. Hand hygiene is efficient, easy to perform and cost-effective. Safety, tolerability and acceptance of hand hygiene preparations play a major role in hand hygiene compliance, and apply, in particular, to formulations with high anti-viral activity. AIM: Clinical trial to evaluate the safety and tolerability of different virucidal hand rubs. METHODS: In a randomized, double-blind, four-period cross-over trial, healthy volunteers received three different virucidal hand rubs (P1-P3) and a reference product (R) in randomized sequence over a period of 4 days each with a washout period. The primary endpoint was skin barrier function measured by transepidermal water loss (TEWL) after application. RESULTS: Twenty-two subjects (seven male, 15 female; median age 25, range 21-54) were randomized and started at least one period. TEWL was 22.5; 95 %-confidence interval (CI): 19.6-25.4 after P1, 16.3; 13.5-19.1 after P2, 16.4; 13.4-19.3 after P3, and 24.0; 21.1-27.0 after R; p < 0.0001. The percentage of subjects experiencing at least one adverse event (AE) was 86 % with P1, 25 % with P2, 89 % with P3 and 56 % with R. The majority of AEs were skin reactions classified as of mild severity. No serious AEs were observed. CONCLUSIONS: Results were inconsistent. The number of AEs was higher than expected for all products. In summary, there is room for improvement both for hand rub development and the scientific approaches taken to practically and reproducibly evaluate hand rub safety and tolerability.