Integrated System for the Proactive Analysis on Infection Risk at a University Health Care Establishment Servicing a Large Area in the South of Italy.

OBJECTIVES: Our study proposes the use of a proactive system to manage risk combining the new Risk Identification Framework by the World Health Organization, the Lean method, and the hospital's Procedure Analysis.The system was tested for the prevention of surgical site infections in the University Hospital of Naples "Federico II" on the surgical paths, where they were usually applied individually. METHODS: We conducted a retrospective observational study from March 18, 2019, to June 30, 2019, at the University Hospital "Federico II" of Naples, Italy (Europe).The study is structured in 3 phases: phase 1, application of each proactive risk management tool (March 18-April 15, 2019); phase 2, analysis and integration of the results, and elaboration of an overview of critical and control points (April 15-20, 2019); and phase 3, evaluation of the outcomes as variation of surgical site infection's incidence between the 3-month period of the 2019 and the same period of the 2018, when each tool was implemented separately (April 30-June 30, 2019). RESULTS: (1) The application of the single tool has detected different criticalities; (2) the combined system allowed us to draw a risk map and identify "improving" macroareas; and (3) the infection rate, with the application of this system, was equal to 1.9%; in the same period of the previous year, it was equal to 4%. CONCLUSIONS: Our study demonstrates that "integrated system" has been more effective to proactively identify surgical route risks compared with the application of each single instrument.

Enhanced liver fibrosis score as a noninvasive biomarker in hepatitis C virus patients after direct-acting antiviral agents.

Background: In more than 90% of chronic viral hepatitis C (HCV) patients treated with direct-acting antiviral agents (DAAs), a sustained viral response (SVR) was observed. Unfortunately, there are subgroups of subjects who display enduring liver fibrosis and are at high risk of developing hepatocellular carcinoma (HCC). Thus, liver fibrosis evaluation during the follow-up of these patients plays a pivotal role. The gold standard to evaluate hepatic fibrosis is liver biopsy, which is an invasive procedure. Imaging techniques and serum biomarkers have been proposed as safer and cheaper procedures. Objectives: In this study, we evaluated the concordance of transient elastography (TE) with ELF score ( enhanced liver fibrosis) in a cohort of patients with HCV before and after direct-acting antiviral (DAAs) treatment. ELF score has been validated in other chronic liver diseases; the evidence is not available in HCV patients treated with DAAs. Study design: We prospectively recruited all consecutive HCV patient candidates for DAAs therapy at the University of Naples "Federico II" between April 2015 and July 2016. TE and ELF scores were assessed at baseline, at SVR24, and at SVR48. Results: One-hundred-nineteen patients were treated with DAAs, and 94.1% of them reached SVR. A total of 55.5% of patients were males with a mean age of 64.7 ± 9.6 years. TE results revealed that 12 patients (10%) had F1-2 mild/moderate fibrosis, and 107 (90%) had F3-4 advanced fibrosis. At baseline, SVR24, and SVR48, the concordance between ELF test and TE was poor: 0.11 (p = 0.086), 0.15 (p = 0.124), and 0.034 (p = 0.002), respectively. However, at SVR24 and SVR48, both methods showed a significant amelioration of liver fibrosis compared to baseline (p < 0.001). In addition, both ELF index and TE were significantly associated with portal hypertension at baseline, but not with varices and ascites. Conclusions: Our findings suggested that ELF test could predict changes in liver fibrosis, independently of TE. In case of TE unavailability, ELF score could represent an appropriate tool. Notably, in the context of the COVID-19 pandemic, ELF testing should be encouraged to reduce unnecessary access to the hospital and prolonged physical contact.

Coffee Silverskin: Chemical and Biological Risk Assessment and Health Profile for Its Potential Use in Functional Foods.

The coffee supply chain is characterized by a complex network with many critical and unsustainable points producing a huge amount of waste products. Among these, coffee silverskin (CS), the only by-product of the coffee roasting phase, has an interesting chemical profile that suggests potential use as a food ingredient. However, few data on its safety are available. For this reason, the purpose of the study was to assess the occurrence of chemical and biological contaminants in CS, and the resulting risk due to its potential consumption. Essential, toxic, and rare earth elements, polycyclic aromatic hydrocarbons (PAHs), process contaminants, ochratoxin A (OTA), and pesticides residues were analyzed in three classes of samples (Coffea arabica CS, Coffea robusta CS, and their blend). Furthermore, total mesophilic bacteria count (TMBC) at 30 °C, Enterobacteriaceae, yeasts, and molds was evaluated. The risk assessment was based upon the hazard index (HI) and lifetime cancer risk (LTCR). In all varieties and blends, rare earth elements, pesticides, process contaminants, OTA, and PAHs were not detected except for chrysene, phenanthrene, and fluoranthene, which were reported at low concentrations only in the arabica CS sample. Among essential and toxic elements, As was usually the most representative in all samples. Microorganisms reported a low load, although arabica and robusta CS showed lower contamination than mixed CS. Instead, the risk assessment based on the potential consumption of CS as a food ingredient did not show either non-carcinogenic or carcinogenic risk. Overall, this study provides adequate evidence to support the safety of this by-product for its potential use in functional foods.

Organisational and Structural Drivers of Childhood Immunisation in the European Region: A Systematic Review.

Despite the implementation of widespread vaccination programs, the European Health Systems continue to experience care challenges attributable to organizational and structural issues. This study aimed to review the available data on aspects within the organizational and structural domains that might impact vaccination coverage. We searched a comprehensive range of databases from 1 January 2007 to 6 July 2021 for studies that reported quantitative or qualitative research on interventions to raise childhood vaccine coverage. Outcome assessments comprised organizational and structural factors that contribute to vaccine concern among pediatric parents, as well as data reported influencing the willingness to vaccinate. To analyze the risk of bias, the Ottawa, JBI's (Joanna Briggs Institute) critical appraisal tool, and Amstar quality assessment were used accordingly. The inclusion criteria were met by 205 studies across 21 articles. The majority of the studies were conducted in the United Kingdom (6), the European Union (3), and Italy (3). A range of interventions studied in primary healthcare settings has been revealed to improve vaccination coverage rates including parental engagement and personalization, mandatory vaccination policies, program redesign, supply chain design, administering multiple/combination vaccines, improved vaccination timing and intervals, parental education and reminders, surveillance tools and Supplemental Immunisation Activity (SIA), and information model.

Association between COVID-19 and Sick Leave for Healthcare Workers in a Large Academic Hospital in Southern Italy: An Observational Study.

Studies have shown that the pandemic has led to an increase in sick leave periods among healthcare workers (HCWs); however, this might have changed over time considering increase in vaccination coverage and change in COVID-19 variant predominance. Therefore, we conducted an observational study to evaluate whether the type of symptoms and the duration of sick leave period for healthcare workers working in a large university hospital in the South of Italy changed between January 2021 and January 2022; 398 cases of COVID-19 were identified for a total of 382 subjects involved. A total of 191 subjects answered the questionnaire about symptoms; of these, 79 had COVID-19 during the period from March 2020 until February 2022. The results showed a decrease of about 1.2 days in sick leave period for each quarter without finding significant differences in the perception of symptoms. It is possible to hypothesize a contribution from the Omicron variant to the decrease in sick leave period in the last quarter, from vaccination coverage, from optimization of COVID-19 management, and from change in the regulations for the assessment of positivity.

Predictive Analysis of Healthcare-Associated Blood Stream Infections in the Neonatal Intensive Care Unit Using Artificial Intelligence: A Single Center Study.

BACKGROUND: Neonatal infections represent one of the six main types of healthcare-associated infections and have resulted in increasing mortality rates in recent years due to preterm births or problems arising from childbirth. Although advances in obstetrics and technologies have minimized the number of deaths related to birth, different challenges have emerged in identifying the main factors affecting mortality and morbidity. Dataset characterization: We investigated healthcare-associated infections in a cohort of 1203 patients at the level III Neonatal Intensive Care Unit (ICU) of the "Federico II" University Hospital in Naples from 2016 to 2020 (60 months). METHODS: The present paper used statistical analyses and logistic regression to identify an association between healthcare-associated blood stream infection (HABSIs) and the available risk factors in neonates and prevent their spread. We designed a supervised approach to predict whether a patient suffered from HABSI using seven different artificial intelligence models. RESULTS: We analyzed a cohort of 1203 patients and found that birthweight and central line catheterization days were the most important predictors of suffering from HABSI. CONCLUSIONS: Our statistical analyses showed that birthweight and central line catheterization days were significant predictors of suffering from HABSI. Patients suffering from HABSI had lower gestational age and birthweight, which led to longer hospitalization and umbilical and central line catheterization days than non-HABSI neonates. The predictive analysis achieved the highest Area Under Curve (AUC), accuracy and F1-macro score in the prediction of HABSIs using Logistic Regression (LR) and Multi-layer Perceptron (MLP) models, which better resolved the imbalanced dataset (65 infected and 1038 healthy).

Evaluation of a fully closed real time PCR platform for the detection of SARS-CoV-2 in nasopharyngeal swabs: a pilot study.

AIMS: To date, reverse transcriptase PCR (RT-PCR) on nasopharyngeal swabs is the 'gold standard' approach for the diagnosis of COVID-19. The need to develop easy to use, rapid, robust and with minimal hands-on time approaches are warranted. In this setting, the Idylla SARS-CoV-2 Test may be a valuable option. The aim of our study is to evaluate the analytical and clinical performance of this assay on previously tested SARS-CoV-2 people by conventional RT-PCR based approach in different settings, including initial diagnosis and clinical follow-up. METHODS: To evaluate the sensitivity and specificity of the Idylla SARS-CoV-2 Test, we retrieved 55 nasopharyngeal swabs, previously analysed by a fully validated assay, from symptomatic patients or from people who have been in close contact with COVID-19 positive cases. Discordant or high discrepant cases were further analysed by a third technique. In addition, a second subset of 14 nasopharyngeal swab samples with uncertain results (cycle threshold between 37 and 40), by using the fully validated assay, from patients with viral infection beyond day 21, were retrieved. RESULTS: Overall, Idylla showed a sensitivity of 93.9% and a specificity of 100.0%. In addition, in the additional 14 nasopharyngeal swab samples, only five (35.7%) featured a positive result by the Idylla SARS-CoV-2 Test. CONCLUSIONS: We demonstrated that the Idylla SARS-CoV-2 Test may represent a valid, fast, highly sensitive and specific RT-PCR test for the identification of SARS-CoV-2 infection.

Interferon beta for the treatment of multiple sclerosis in the Campania Region of Italy: Merging the real-life to routinely collected healthcare data.

BACKGROUND: We aim to overcome limitations of previous clinical and population-based studies by merging a clinical registry to routinely-collected healthcare data, and to specifically describe differences in clinical outcomes, healthcare resource utilization and costs between interferon beta formulations for multiple sclerosis (MS). METHODS: We included 850 patients with MS treated with interferon beta formulations, from 2015 to 2019, seen at the MS Clinical Care and Research Centre (Federico II University of Naples, Italy) and with linkage to routinely-collected healthcare data (prescription data, hospital admissions, outpatient services). We extracted and computed clinical outcomes (relapses, 6-month EDSS progression using a roving EDSS as reference), persistence (time spent on a specific interferon beta formulation), adherence (medication possession ratio (MPR)), healthcare resource utilization and costs (annualized hospitalization rate (AHR), costs for hospital admissions and DMTs). To evaluate differences between interferon beta formulations, we used linear regression (adherence), Poisson regression (AHR), mixed-effect regression (costs), and Cox-regression models (time varying variables); covariates were age, sex, treatment duration, baseline EDSS and adherence. RESULTS: Looking at clinical outcomes, rates of relapses and EDSS progression were lower than studies run on previous cohorts; there was no differences in relapse risk between interferon beta formulations. Risk of discontinuation was higher for Betaferon®/Extavia® (HR = 3.28; 95%CI = 2.11, 5.12; p<0.01). Adherence was lower for Betaferon®/Extavia® (Coeff = -0.05; 95%CI = -0.10, -0.01; p = 0.02), and Avonex® (Coeff = -0.06; 95%CI = -0.11, -0.02; p<0.01), when compared with Rebif® and Plegridy® (Coeff = 0.08; 95%CI = 0.01, 0.16; p = 0.02). AHR and costs for MS hospital admissions were higher for Betaferon®/Extavia® (IRR = 2.38; 95%CI = 1.01, 5.55; p = 0.04; Coeff = 14.95; 95%CI = 1.39, 28.51; p = 0.03). CONCLUSIONS: We have showed the feasibility of merging routinely-collected healthcare data to a clinical registry for future MS research, and have confirmed interferon beta formulations play an important role in the management of MS, with positive clinical outcomes. Differences between interferon beta formulations are mostly driven by adherence and healthcare resource utilization.

Risk Analysis in Healthcare Organizations: Methodological Framework and Critical Variables.

PURPOSE: A risk assessment matrix is a widely used tool for analyzing, assessing and setting priorities in risk management in many fields. This paper overviews critical variables, advantages, disadvantages, strengths and weaknesses of this tool, according to the ISO 31000 risk management framework. RESULTS: Risk assessment is one of the key stages in the Risk Management Process and involves specific steps: identifying hazards, analyzing and evaluating all possible risks. Several methods are developed to assess risks in the literature. A risk matrix method, also called "decision matrix risk assessment (DMRA) technique", is a systematic approach used to determine the risk level and to compare different risks and define which threats need to be controlled first. The actors involved in risk assessment are called on to manage different issues related to the choice of the most appropriate methodological approach, the assessment of the adequacy of the existing control measures, the articulation of risk consequence domains, the definition of the impact-consequences, the explanation of risk likelihood scales and the development of a risk matrix. CONCLUSION: We highlighted a number of recommendations in order to address these issues, especially useful when healthcare organizations provide insufficient guidance on how to use risk matrices as well as what to do in response to the existing criticisms on their use.

Diagnostic and infection control strategies for Clostridioides difficile infections in a setting of high antimicrobial resistance prevalence.

Clostridioides difficile (CD) is a major nosocomial pathogen and the leading cause of antibiotic-associated diarrhoea. In light of the strong association between antimicrobial use and CD infections (CDI), it may be hypothesised that areas at higher prevalence of antimicrobial resistance, like the region of Campania in southern Italy, could also have a higher rate of CDI. In this multicentre, region-based, prospective study, we analysed such issues, exploiting CDI incidence data collected from local hospitals. In 2016, the Italian National Centre for Disease Control supported a project involving three Italian regions: Friuli Venezia Giulia, Lazio and Campania. In Campania, a network of 49 hospitals willing to participate in the project was created. The project consisted of two phases: a survey on practice patterns concerning CDI and an epidemiological surveillance study. We identified a stringent need to improve awareness about CDI among the regional health-care community, as a widespread lack of surveillance programmes for CDI control was observed (existing in only 40% of participating facilities). Moreover, almost half of the participating hospitals (n=16, 43%) had no standardised procedures or protocols to control and prevent CDI. In the second phase of the study, we collected data of CDI cases during a six-month surveillance programme. In all, 87 CDI cases were observed, for a total of 903,334 patient bed-days and 122,988 admissions. According to the above data, CDI incidence was 0.96 cases/10000 patient bed-days, much lower than expected based on prior studies conducted elsewhere. The results of our study suggest CDI remains a rather neglected clinical issue in Campania. Despite a high burden of antimicrobial resistance and antimicrobial use in our geographic setting, we observed a very low incidence of CDI. Such a low incidence could be explained by underdiagnosis, but could also be related to actual diet, the lower patient age or the specific genetic background. However, further studies are warranted to either confirm or rebut the above hypotheses.

Risk of SARS-CoV-2 Transmission in Health Care Personnel Working in a Pediatric COVID-19 Unit.

OBJECTIVES: The paucity of symptoms and the difficulties in wearing personal protective equipment make children a potential source of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection for health care workers (HCWs). Previous experience in pediatric settings reported high rate of intrahospital SARS-CoV-2 transmission in HCWs caring for children. We aimed at investigating the rate and determinants of SARS-CoV-2 infection among HCWs working in a regional reference center in the Southern Italy. METHODS: A prospective observational study was conducted to monitor the occurrence of SARS-CoV-2 infections among HCWs and investigate the relation between the infection rate and hours of exposure or number and characteristics of procedures, including nasopharyngeal swab, high-flow oxygen delivery, suctioning of airway secretions, sputum induction, and nebulizer administration. RESULTS: After 5 months of monitoring, 425.6 hours of SARS-CoV-2 exposure (18.5 hours per person), and 920 hospital procedures, no case of nosocomial transmission was reported among the 23 HCWs enrolled in the study. CONCLUSIONS: The application of stringent preventive measures, also outside the area dedicated to patients' care, can effectively control infection spreading also in pediatric settings.

Prevalence of SARS-CoV-2 Antibodies in Multiple Sclerosis: The Hidden Part of the Iceberg.

BACKGROUND: We compared the prevalence of SARS-CoV-2 IgG/IgM in multiple sclerosis (MS), low-risk, and high-risk populations and explored possible clinical correlates. METHODS: In this cross-sectional study, we recruited MS patients, low-risk (university staff from non-clinical departments), and high-risk individuals (healthcare staff from COVID-19 wards) from 11 May to 15 June 2020. We used lateral flow immunoassay to detect SARS-CoV-2 IgG and IgM. We used t-test, Fisher's exact test, chi square test, or McNemar's test, as appropriate, to evaluate between-group differences. RESULTS: We recruited 310 MS patients (42.3 ± 12.4 years; females 67.1%), 862 low-risk individuals (42.9 ± 13.3 years; females 47.8%), and 235 high-risk individuals (39.4 ± 10.9 years; females 54.5%). The prevalence of SARS-CoV-2 IgG/IgM in MS patients (n = 9, 2.9%) was significantly lower than in the high-risk population (n = 25, 10.6%) (p < 0.001), and similar to the low-risk population (n = 11, 1.3%) (p = 0.057); these results were also confirmed after random matching by age and sex (1:1:1). No significant differences were found in demographic, clinical, treatment, and laboratory features. Among MS patients positive to SARS-CoV-2 IgG/IgM (n = 9), only two patients retrospectively reported mild and short-lasting COVID-19 symptoms. CONCLUSIONS: MS patients have similar risk of SARS-CoV-2 infection to the general population, and can be asymptomatic from COVID-19, also if using treatments with systemic immunosuppression.

Health-care organization for the management and surveillance of SARS-CoV-2 infection in children during pandemic in Campania region, Italy.

BACKGROUND: In comparison with adults, severe acute respiratory syndrome coronavirus (SARS-CoV-2) infection in children has a milder course. The management of children with suspected or confirmed coronavirus disease (COVID-19) needs to be appropriately targeted. METHODS: We designed a hub-and-spoke system to provide healthcare indications based on the use of telemedicine and stringent admission criteria, coordinate local stakeholders and disseminate information. RESULT: Between March 24th and September 24th 2020, the Hub Centre managed a total of 208 children (52% males, median age, 5.2, IQR 2-9.6 years) with suspected or confirmed COVID-19. Among them, 174 were managed in cooperation with family pediatricians and 34 with hospital-based physicians. One hundred-four (50%) received a final diagnosis of SARS-CoV-2 infection. Application of stringent criteria for hospital admission based on clinical conditions, risk factors and respect of biocontainment measures, allowed to manage the majority of cases (74, 71.1%) through telemedicine. Thirty children (28%) were hospitalized (median length 10 days, IQR 5-19 days), mainly due to the presence of persistent fever, mild respiratory distress or co-infection occurring in infant or children with underlying conditions. However, the reasons for admission slightly changed over time. CONCLUSION: An hub-and-spoke system is effective in coordinate territorial health-care structures involved in management paediatric COVID-19 cases through telemedicine and the definition of stringent hospital admission criteria. The management of children with COVID-19 should be based on clinical conditions, assessed on a case-by-case critical evaluation, as well as on isolation measures, but may vary according to local epidemiological changes.

Optimising triage procedures for patients with cancer needing active anticancer treatment in the COVID-19 era.

BACKGROUND: Immunosuppression induced by anticancer therapy in a COVID-19-positive asymptomatic patient with cancer may have a devastating effect and, eventually, be lethal. To identify asymptomatic cases among patients receiving active cancer treatment, the Federico II University Hospital in Naples performs rapid serological tests in addition to hospital standard clinical triage for COVID-19 infection. METHODS: From 6 to 17 April 2020, all candidates for chemotherapy, radiotherapy or target/immunotherapy, if negative at the standard clinical triage on the day scheduled for anticancer treatment, received a rapid serological test on peripheral blood for COVID-19 IgM and IgG detection. In case of COVID-19 IgM and/or IgG positivity, patients underwent a real-time PCR (RT-PCR) SARS-CoV-2 test to confirm infection, and active cancer treatment was delayed. RESULTS: Overall 466 patients, negative for COVID-19 symptoms, underwent serological testing in addition to standard clinical triage. The average age was 61 years (range 25-88 years). Most patients (190, 40.8%) had breast cancer, and chemotherapy with or without immunotherapy was administered in 323 (69.3%) patients. Overall 433 (92.9%) patients were IgG-negative and IgM-negative, and 33 (7.1%) were IgM-positive and/or IgG-positive. Among the latter patients, 18 (3.9%), 11 (2.4%) and 4 (0.9%) were IgM-negative/IgG-positive, IgM-positive/IgG-negative and IgM-positive/IgG-positive, respectively. All 33 patients with a positive serological test, tested negative for RT-PCR SARS-CoV-2 test. No patient in our cohort developed symptoms suggestive of active COVID-19 infection. CONCLUSION: Rapid serological testing at hospital admission failed to detect active asymptomatic COVID-19 infection. Moreover, it entailed additional economic and human resources, delayed therapy administrationand increased hospital accesses.

COVID-19 prevention and multiple sclerosis management: The SAFE pathway for the post-peak.

BACKGROUND: We hereby report on our experience from Naples (South Italy), where the peak of coronavirus disease 2019 (COVID-19) has already passed. METHODS: Assuming that COVID-19 will be circulating until vaccination and/or herd immunity is achieved (possibly not earlier than 2021), we have developed a protocol for the long-term management of multiple sclerosis (MS). RESULTS: We have defined a pathway for the access to the MS Centre with logistic, preventative and clinical recommendations, and have also included 14-day self-isolation and COVID-19 testing before some disease modifying treatments. DISCUSSION: Overall, we believe our experience could be helpful for MS management in the upcoming months.

The application of Lean Six Sigma methodology to reduce the risk of healthcare-associated infections in surgery departments.

RATIONALE: Nowadays, the monitoring and prevention of healthcare-associated infections (HAIs) is a priority for the healthcare sector. AIMS AND OBJECTIVES: In this article, we report on the application of the Lean Six Sigma (LSS) methodology to reduce the number of patients affected by sentinel bacterial infections who are at risk of HAI. METHODS: The LSS methodology was applied in the general surgery department by using a multidisciplinary team of both physicians and academics. Data on more than 20 000 patients who underwent a wide range of surgical procedures between January 2011 and December 2014 were collected to conduct the study using the departmental information system. The most prevalent sentinel bacteria were determined among the infected patients. The preintervention (January 2011 to December 2012) and postintervention (January 2013 to December 2014) phases were compared to analyze the effects of the methodology implemented. The methodology allowed the identification of variables that influenced the risk of HAIs and the implementation of corrective actions to improve the care process, thereby reducing the percentage of infected patients. RESULTS: The improved process resulted in a 20% reduction in the average number of hospitalization days between preintervention and control phases, and a decrease in the mean (SD) number of days of hospitalization amounted to 36 (15.68), with a data distribution around 3 σ. The LSS is a helpful strategy that ensures a significant decrease in the number of HAIs in patients undergoing surgical interventions. The implementation of this intervention in the general surgery departments resulted in a significant reduction in both the number of hospitalization days and the number of patients affected by HAIs. CONCLUSIONS: This approach, together with other tools for reducing the risk of infection (surveillance, epidemiological guidelines, and training of healthcare personnel), could be applied to redesign and improve a wide range of healthcare processes.

Season of birth and Parkinson's disease: possible relationship?

The amount of sun exposure in early life and consequent vitamin D3 level may influence the risk of developing Parkinson's disease (PD). Yet few studies have previously investigated birth trends in PD related to a possible seasonality and sun exposure. The aim of this study was to investigate a possible relationship between PD risk and sun exposure looking at seasonal birth variation of PD subjects in the homogenous geographic area of Naples, Italy. We selected 898 PD subjects and matched with 1796 controls. McNemar's test with Bonferroni correction and autocorrelation were used to test seasonality in birth trends. No difference was found for the month and season of birth between PD subjects and controls. We found a 3.3 % increase of PD female subjects born in September (3.3 %) and 4.1 % increase of PD male subjects born in spring comparing to controls but were not significant after Bonferroni correction. This study evaluated for the first time the seasonal birth trends in relation to PD risk in a Southern European population. We found no association between seasonal birth variations and risk of PD.

Serum in vivo and in vitro activity of single dose of ertapenem in surgical obese patients for prevention of SSIs.

BACKGROUND: Despite progress made in the control of post-operative infections, the incidence of surgical site infections (SSIs) is still high. An improper perioperative antibiotic use can expose patients to the risk of resistant microorganisms, and, in surgical obese patients, the drug dosage and infusion time are critical points. The aim of our study was to evaluate the effectiveness of ertapenem in the prophylaxis of SSIs in obese patients undergoing general or bariatric surgery. METHODS: A total of 63 obese patients, candidates for several surgical interventions, were enrolled and divided into two groups. Patients received antibiotic prophylaxis before surgery: the case group received venous infusion of ertapenem; the control group received standard prophylaxis. Serum samples were tested for antimicrobial activity against Gram-positive and Gram-negative bacteria. RESULTS: After single-dose ertapenem in obese patients, we registered in vitro activity of sera against the growth of non-extended beta lactamase (ESBL)-producing Escherichia coli, Proteus mirabilis, Citrobacter freundii, Enterobacter cloacae, and non-ESBL-producing Klebsiella pneumoniae. Moreover, methicillin-sensitive Staphylococcus aureus and Streptococcus viridans were also inhibited. We found in vivo efficacy according to clinical monitoring: at the weekly and monthly follow-ups, one patient in the case group and six patients in the control group presented superficial incisional SSIs. CONCLUSIONS: These preliminary results are suggestive of the efficacy of ertapenem in perioperative prophylaxis of SSIs in obese patients; however, they need to be confirmed by further investigations and more defined trials.