Antiseptic Skin Agents to Prevent Surgical Site Infection After Incisional Surgery: A Randomized, Three-armed Combined Non-inferiority and Superiority Clinical Trial (NEWSkin Prep Study)

alexandrossfakianakis shared this article with you from Inoreader Antiseptic Skin Agents to Prevent Surgical Site Infection After Incisional Surgery: A Randomized, Three-armed Combined Non-inferiority and Superiority Clinical Trial (NEWSkin Prep Study) via Annals of Surgery - Most Popular Articles Objective: To compare SSI rates between the skin preparation agents: PI-Aq, povidone-iodine with alcohol (PI-Alc), and chlorhexidine with alcohol (C-Alc). Background: Guidelines suggest that alcohol-containing chlorhexidine solutions are the gold standard for skin preparation before surgery. It remains difficult to determine whether it is the chlorhexidine component or the addition of alcohol that confers the most benefit. Methods: We conducted a multicenter, prospective, combined non-inferiority (PI-Alc vs C-Alc) and superiority (PI-Alc vs PI-Aq) randomized clinical trial. Participants were randomized 1:1:1 to receive either C-Alc, PI-Alc, or PI-Aq. The primary outcome was SSI rate as defined by the Centers for Disease Control. Secondary outcomes were complication rates, length of hospital stay, readmissions, and skin reactions. Results: Between January 2015 and December 2018, 3213 patients were randomized (C-Alc: 1076, PI-Alc: 1075, and PI-Aq: 1062). Mean age of participants was 57% and 55% were female. SSI rates were: C-Alc 11.09%, PI-Alc 10.88%, and PI-Aq 12.56%. PI-Alc was found to be non-inferior to C-Alc (mean difference, −0.21%; 95% confidence interval, −2.85 to 2.44; P = 0.0009 non-inferiority), whereas PI-Alc was not superior to PI-Aq (mean difference, −1.68%; 95% confidence interval, −4.40 to 1.05; P = 0.2302). There were no differences seen in secondary outcomes between groups and no treatment related adverse events or deaths occurred. Conclusions: PI-Alc is non-inferior to C-Alc and not superior to PI-Aq. This is at odds with current guidelines that suggest alcohol-based chlorhexidine solutions should routinely be used for surgical skin preparation. Trial Registration: Australia and New Zealand Clinical Trials Registry: ANZCTRN12615000021571. www.anzctr.org.au View on Web

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Sentinel Node Biopsy Imaging in Breast Cancer: Scatter Reduction Using 3-Dimensionally Printed Lead Shields

alexandrossfakianakis shared this article with you from Inoreader Sentinel Node Biopsy Imaging in Breast Cancer: Scatter Reduction Using 3-Dimensionally Printed Lead Shields via Clinical Nuclear Medicine - Published Ahead-of-Print Background Point of injection scatter (SPI) confounds breast cancer sentinel lymph node detection. Round flat lead shields (FLSs) incompletely reduce SPI, requiring repositioning. We designed lead shields that reduce SPI and acquisition time. Methods Two concave lead shields, a semioval lead shield (OLS) and a semispherical lead alloy shield (SLS), were created with a SICNOVA JCR 1000 3D printer to cover the point of injection (patent no. ES1219895U). Twenty breast cancer patients had anterior and anterior oblique imaging, 5 minutes and 2 hours after a single 111 MBq nanocolloid in 0.2 mL intratumoral or periareolar injection. Each acquisition was 2 minutes. Absolute and normalized background corrected scatter counts (CSCs) and scatter reduction percentage (%SR) related to the FLS were calculated. Repositionings were recorded. Differences between means of %SR (t test) and between means of CSC (analysis of variance) with Holm multiple comparison tests were determined. Results Mean %SR was 91.8% with OLS and 92% using SLS in early images (P = 0.91) and 87.2%SR in OLS and 88.5% in late images (P = 0.66). There were significant differences between CSC using FLS and OLS (P View on Web

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Abszesstonsillektomie: Uni- oder bilateral?

alexandrossfakianakis shared this article with you from Inoreader Abszesstonsillektomie: Uni- oder bilateral? via Laryngo-Rhino-Otologie Laryngorhinootologie DOI: 10.1055/a-1841-6419 Hintergrund Zusätzlich zu einer empirischen Antibiotikagabe kommt als Therapie eines Peritonsillarabszesses (PTA) neben der Drainage von Pus auch die Abszesstonsillektomie (ABTE) infrage. Die Nachblutung nach ABTE ist eine gefürchtete Komplikation und kann in seltenen Fällen bis zum Tod des Patienten führen. Ziel dieser Studie war der Vergleich von ABTEs mit und ohne kontralaterale Tonsillektomie (TE) bezüglich Blutungskomplikationen. Zusätzlich wurde das Auftreten von metachronen PTAs auf der Gegenseite untersucht. Material und Methoden Retrospektive Studie von n=655 Patient*innen, die im Zeitraum von Januar 2004 bis Dezember 2019 eine ABTE mit oder ohne kontralaterale TE erhielten. Die operationspflichtigen Nachblutungen wurden in Abhängigkeit von demografischen und chirurgischen Parametern untersucht. Des Weiteren wurde evaluiert, wie häufig es nach unilateraler ABTE zu einem PTA mit Notwendigkeit einer ABTE der kontralateralen Seite kommt. Ergebnisse Insgesamt kam es bei 10/655 (1,5%) zu einer operationsbedürftigen Nachblutung. Bei 404/655 wurde eine ABTE mit kontralateraler TE durchgeführt. Hier zeigte sich bei 8/404 (1,98%) die Blutung kontra- oder bilateral. Nur 2 Patient*innen (2/251, 0,7%) mit unilateraler ABTE bluteten nach. Die Nachblutungsrate nach unilateraler ABTE war signifikant niedriger als bei ABTE mit kontralateraler TE (0,7% vs. 1,98%; p=0,001). Bei 0,8% der Patient*innen erfolgte bei metachronem PTA eine ABTE der Gegenseite. Schlussfolgerungen Insgesamt zeigte sich die Nachblutungsrate nach ABTE mit 1,5% gering. Die Nachblutungsrate nach unilateraler ABTE war signifikant geringer als nach ABTE mit kontralateraler TE. Daher sollte die Indikation zur kontralateralen TE bei unilateralem PTA streng gestellt werden. [...] Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany Article in Thieme eJournals: Table of contents  |  Abstract  |  Full text View on Web

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Die Vagusnervstimulation bei konservativ therapierefraktärer Epilepsie und DepressionVagus nerve stimulation for conservative therapy-refractive epilepsy and depression

alexandrossfakianakis shared this article with you from Inoreader Die Vagusnervstimulation bei konservativ therapierefraktärer Epilepsie und DepressionVagus nerve stimulation for conservative therapy-refractive epilepsy and depression via Laryngo-Rhino-Otologie Laryngorhinootologie 2022; 101: S114-S143 DOI: 10.1055/a-1660-5591 Zahlreiche Studien belegen, dass die Vagusnervstimulation (VNS) eine effiziente indirekte neuromodulatorische Therapie mit intermittierend appliziertem elektrischen Strom darstellt für die medikamentös therapierefraktäre Epilepsie, die nicht epilepsiechirurgisch interveniert werden kann, und die medikamentös therapierefraktäre Depression. Bei der VNS handelt es sich um eine etablierte, Evidenz basierte und in der Langzeitbetrachtung kosteneffektive Therapie in einem interdisziplinären Gesamtkonzept.Es existieren Langzeitdaten zu Sicherheit und Verträglichkeit der Methode trotz großer Heterogenität der Patientenkollektive. Stimulationsbed ingte Nebenwirkungen wie Heiserkeit, Parästhesien, Husten, Dyspnoe sind abhängig von der Stimulationsstärke und häufig mit fortschreitender Therapiedauer in den Folgejahren rückläufig. Stimulationsbezogene Nebenwirkungen der VNS sind durch Veränderung der Stimulationsparameter gut beeinflussbar. Insgesamt ist die invasive Vagusnervstimulation als sichere und gut verträgliche Therapieoption anzusehen.Für die invasive und transkutane Vagusnervstimulation sind die antiepileptischen und antidepressiven sowie positive kognitive Effekte belegt. Im Gegensatz zu den Medikamenten wirkt sich die VNS nicht negativ auf die Kognition aus. Eine verbesserte Lebensqualität ist in vielen Fällen möglich.Die iVNS-Therapie hat eine geringe Wahrscheinlichkeit der kompletten Anfallsfreiheit bei fokaler und genetisch generalisierter Epilepsie. Sie ist als palliative Therapie anzusehen, dass heisst, sie führt nicht zur Heilung und erfordert die Fortführung der spezifischen Medikation. Als W irkprinzip wird eine allgemeine Reduktion neuronaler Exzitabilität betrachtet. Dieser Effekt stellt sich in einer langsamen Wirksamkeitssteigerung zum Teil über Jahre ein. Als Responder zählen Patienten mit einer mindestens 50%igen Reduktion der Anfallshäufigkeit. In Studien zeigt sich zum Teil in 20% der Fälle eine Anfallsfreiheit. Derzeit ist es nicht möglich, prätherapeutisch/präoperativ zwischen potentiellen Respondern und Non- Respondern zu differenzieren.Durch die aktuellen technischen Weiterentwicklungen der VNS zur responsiven VNS Therapy mit Herzraten-basierter-Anfalls-Erkennung (CBSD) reduziert sich neben der Epilepsie-Anfallsschwere auch das SUDEP-Risiko (sudden unexpected death in epilepsy patients).Die iVNS kann ein Schlaf-Apnoe-Syndrom verschlechtern und kann neben der engen Zusammenarbeit mit den Schlafmedizinern gegebenfalls eine nächtliche Therapiepause (z. B. Tag/Nacht-Programmierung) erfordern.In Auswertung der zahlreichen iVNS-Studien der letzten 2 Ja hrzehnte zeigten sich vielfältige positive Effekte auf weitere immunologische, kardiologische und gastroenterologische Erkrankungen, so dass sich je nach zukünftigen Studienergebnissen zusätzliche Therapieindikationen erwarten lassen. Aktuell ist die Vagusnervstimulation Gegenstand der Forschung in den Bereichen der Psychologie, Immunologie, Kardiologie, sowie Schmerz- oder Plastizitätsforschung mit erhofftem Potenzial zur zukünftigen medizinischen Anwendung.Neben der invasiven Vagusnervstimulation wurden in den letzten Jahren Geräte zur transdermalen und somit nicht invasiven Vagusnervstimulation entwickelt. Diese haben nach den derzeit zur Verfügung stehenden Daten eine etwas geringere Wirksamkeit hinsichtlich der Verminderung von Anfallsschwere und Anfallsdauer bei der therapierefraktären Epilepsie und eine etwas geringe Wirksamkeit bei der Verbesserung von Symptomen der Depression. Hierzu fehlen in vielen Fällen noch Studien, die eine hohe Evidenz der Wirksamkeit nachw eisen. Gleiches gilt für die beschriebenen sonstigen Indikationen wie z. B. Tinnitus, Cephalgien, Magen-Darm-Beschwerden etc. Ein weiterer Nachteil der transkutanen Vagusnervstimulation liegt darin, dass die Stimulatoren vom Patienten aktiv angesetzt werden müssen und somit nur intermittierend wirksam sind, was eine hohe Therapieadhärenz unsicher macht.Numerous studies confirm that the vagus nerve stimulation (VNS) is an efficient, indirect neuromodulatory therapy with electrically induced current for epilepsy that cannot be treated by epilepsy surgery and is therapy-refractory and for drug therapy-refractory depression. VNS is an established, evidence-based and in the long-term cost-effective therapy in an interdisciplinary overall concept.Long-term data on the safety and tolerance of the method are available despite the heterogeneity of the patient populations. Stimulation-related side effects like hoarseness, paresthesia, cough or dyspnea depend on the stimulation strength a nd often decrease with continuing therapy duration in the following years. Stimulation-related side effects of VNS can be well influenced by modifying the stimulation parameters. Overall, the invasive vagus nerve stimulation may be considered as a safe and well-tolerated therapy option.For invasive and transcutaneous vagus nerve stimulation, antiepileptic and antidepressant as well as positive cognitive effects could be proven. In contrast to drugs, VNS has no negative effect on cognition. In many cases, an improvement of the quality of life is possible.iVNS therapy has a low probability of complete seizure-freedom in cases of focal and genetically generalized epilepsy. It must be considered as palliative therapy, which means that it does not lead to healing and requires the continuation of specific medication. The functional principle is a general reduction of the neuronal excitability. This effect is achieved by a slow increase of the effectiveness sometimes over several years. Re sponders are those patients who experience a 50% reduction of the seizure incidence. Some studies even reveal seizure-freedom in 20% of the cases. Currently, it is not possible to differentiate between potential responders and non-responders before therapy/implantation.The current technical developments of the iVNS generators of the new generation like closed-loop system (cardiac-based seizure detection, CBSD) reduce also the risk for SUDEP (sudden unexpected death in epilepsy patients), a very rare, lethal complication of epilepsies, beside the seizure severity.iVNS may deteriorate an existing sleep apnea syndrome and therefore requires possible therapy interruption during nighttime (day-night programming or magnet use) beside the close cooperation with sleep physicians.The evaluation of the numerous iVNS trials of the past two decades showed multiple positive effects on other immunological, cardiological, and gastroenterological diseases so that additional therapy indications may be expected depending on future study results. Currently, the vagus nerve stimulation is in the focus of research in the disciplines of psychology, immunology, cardiology as well as pain and plasticity research with the desired potential of future medical application.Beside invasive vagus nerve stimulation with implantation of an IPG and an electrode, also devices for transdermal and thus non-invasive vagus nerve stimulation have been developed during the last years. According to the data that are currently available, they are less effective with regard to the reduction of the seizure severity and duration in cases of therapy-refractory epilepsy and slightly less effective regarding the improvement of depression symptoms. In this context, studies are missing that confirm high evidence of effectiveness. The same is true for the other indications that have been mentioned like tinnitus, cephalgia, gastrointestinal complaints etc. Another disadvantage of transcutaneous vagus nerve stimu lation is that the stimulators have to be applied actively by the patients and are not permanently active, in contrast to implanted iVNS therapy systems. So they are only intermittently active; furthermore, the therapy adherence is uncertain. [...] Georg Thieme Verlag KG Rüdigerstraße 14, 70469 Stuttgart, Germany Article in Thieme eJournals: Table of contents  |  Abstract  |  open access Full text View on Web

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Understanding Variation in Rotavirus Vaccine Effectiveness Estimates

alexandrossfakianakis shared this article with you from Inoreader Understanding Variation in Rotavirus Vaccine Effectiveness Estimates in the United States: The Role of Rotavirus Activity and Diagnostic Misclassification via Epidemiology - Published Ahead-of-Print Background: Estimates of rotavirus vaccine effectiveness (VE) in the U.S. appear higher in years with more rotavirus activity. We hypothesized rotavirus VE is constant over time but appears to vary as a function of temporal variation in local rotavirus cases and/or misclassified diagnoses. Methods: We analyzed 6 years of data from eight U.S. surveillance sites on 8-59-month olds with acute gastroenteritis symptoms. Children's stool samples were tested via enzyme immunoassay (EIA); rotavirus-positive results were confirmed with molecular testing at the US Centers for Disease Control and Prevention (CDC). We defined rotavirus gastroenteritis cases by either positive on-site EIA results alone or positive EIA with CDC confirmation. For each case definition, we estimated VE against any rotavirus gastroenteritis, moderate-to-severe disease, and hospitalization using two mixed-effect regression models: the first including year plus a year–vaccination interaction, and the second including annual percent of rotavirus positive tests plus a percent positive–vaccination interaction. We used multiple overimputation to bias-adjust for misclassification of cases defined by positive EIA alone. Results: Estimates of annual rotavirus VE against all outcomes fluctuated temporally, particularly when we defined cases by on-site EIA alone and used a year–vaccination interaction. Use of confirmatory testing to define cases reduced, but did not eliminate, fluctuations. Temporal fluctuations in VE estimates further attenuated when we used a percent positive–vaccination interaction. Fluctuations persisted until bias-adjustment for diagnostic misclassification. Conclusions: Both controlling for time-varying rotavirus activity and bias-adjusting for diagnostic misclassification are critical for estimating the most valid annual rotavirus VE. Copyright © 2022 Wolters Kluwer Health, Inc. All rights reserved. View on Web

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Promoter hypermethylation of GALR1 acts as an early epigenetic susceptibility event in colorectal carcinogenesis

alexandrossfakianakis shared this article with you from Inoreader Promoter hypermethylation of <i>GALR1</i> acts as an early epigenetic susceptibility event in colorectal carcinogenesis via Journal of Human Genetics - Issue - nature.com science feeds View on Web

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Activation of the mitogen‐activated protein kinase–extracellular signal‐regulated kinase pathway in childhood B‐cell acute lymphoblastic leukemia

alexandrossfakianakis shared this article with you from Inoreader Activation of the mitogen‐activated protein kinase–extracellular signal‐regulated kinase pathway in childhood B‐cell acute lymphoblastic leukemia via Pediatric Blood & Cancer Abstract RAS mutations are frequently observed in childhood B-cell acute lymphoblastic leukemia (B-ALL) and previous studies have yielded conflicting results as to whether they are associated with a poor outcome. We and others have demonstrated that the mitogen-activated protein kinase–extracellular signal-regulated kinase (MAPK) pathway can be activated through epigenetic mechanisms in the absence of RAS pathway mutations. Herein, we examined whether MAPK activation, as determined by measuring phosphorylated extracellular signal-regulated kinase (pERK) levels in 80 diagnostic patient samples using phosphoflow cytometry, could be used as a prognostic biomarker for pediatric B-ALL. The mean fluorescence intensity of pERK (MFI) was measured at baseline and after exogenous stimulation with or without pretreatment with the mitogen-activated protein kinase kinase (MEK) inhibitor trametinib. Activation levels (MFI stimulated/MFI baseline) ranged from 0.76 to 4.40 (median =&n bsp;1.26), and inhibition indexes (MFI stimulated/MFI trametinib stimulated) ranged from 0.439 to 5.640 (median = 1.30), with no significant difference between patients with wildtype versus mutant RAS for either. Logistic regression demonstrated that neither MAPK activation levels nor RAS mutation status at diagnosis alone or in combination was prognostic of outcome. However, 35% of RAS wildtype samples showed MAPK inhibition indexes greater than the median, thus raising the possibility that therapeutic strategies to inhibit MAPK activation may not be restricted to patients whose blasts display Ras pathway defects. View on Web

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Application of an Environmental Monitoring to Assess the Practices and Control the Risk of Occupational Exposure to Cyclophosphamide in Two Sites of a French Comprehensive Cancer Center

alexandrossfakianakis shared this article with you from Inoreader Application of an Environmental Monitoring to Assess the Practices and Control the Risk of Occupational Exposure to Cyclophosphamide in Two Sites of a French Comprehensive Cancer Center via Annals of Work Exposures and Health Advance Access Abstract Objectives The risk of chronic exposure to antineoplastic agents in hospitals, mainly by skin contact with contaminated surfaces, is well established. The aim of this study was to assess indirectly the risk of occupational exposure to antineoplastics drugs at two hospitals by using an environmental monitoring, and to suggest ways of improving the exposure to healthcare workers. Methods An observational study of care practices on both sites was carried out. A wipe sampling campaign was then designed to study environmental contamination throughout the chemotherapy process: receipt, storage, compounding, transport, administration, and elimination areas. Samples were analyzed by a validated LC-MS/MS method allowing trace quantification of cyclophosphamide. A guidance 'safe value' of 0.10 ng/cm2 was considered. Results A total of 293 samples were analyzed, of which 58% were found to be positive. In the compou nding units, the drug vials were contaminated before [range = (non-quantifiable [NQ]-0.71) ng/cm2] and after cleaning procedure [(NQ-0.62) ng/cm2], particularly when the flip-off lid was removed during cleaning. The contamination found on manual preparations was operator-dependent: [non-detectable (ND)-3.51] ng/cm2 on infusion bag surfaces; (780.61–24 698.98) ng/cm2 on medication ports. In the case of automated preparations, the average contamination was higher on infusion bag surfaces [(2.43–36.86) ng/cm2] and lower on medication ports [(0.43–7.65) ng/cm2] than manual preparations. Contamination of the analytical control area was also highlighted. In the daily care unit, the contamination was located near the infusion area (armchairs, infusion stands, floor, and patient toilets), and varied somewhat between the two sites, especially on the floor with (0.46–27.32) compared to (ND-0.18) ng/cm2. We di d not detect contamination on the transport boxes, on the door handles or in the disposal areas. Conclusions The variability of contamination observed between the two sites can be explained in part by the difference in routine practices, especially training of the staff, and cleaning procedures. Findings were communicated to healthcare workers, and news interventions were implemented based on wipe sampling results. This study demonstrated a method for routine environmental monitoring and worker education as a strategy to reduce occupational exposure. View on Web

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Diagnostic potential of extracellular vesicles in meningioma patients

alexandrossfakianakis shared this article with you from Inoreader Diagnostic potential of extracellular vesicles in meningioma patients via Neuro-Oncology Advance Access Abstract Background Extracellular vesicles (EVs) play an important role in cell-cell communication, and tumor-derived EVs circulating in patient blood can serve as biomarkers. Here, we investigated the potential role of plasma EVs in meningioma patients for tumor detection and determined whether EVs secreted by meningioma cells reflect epigenetic, genomic and proteomic alterations of original tumors. Methods EV concentrations were quantified in patient plasma (n = 46). Short-term meningioma cultures were established (n = 26) and secreted EVs were isolated. Methylation and copy number profiling was performed using 850k arrays, and mutations were identified by targeted gene panel sequencing. Differential quantitative mass spectrometry was employed for proteomic analysis. Results Levels of circulating EVs were elevated in meningioma patients compared to healthy individuals, and the plasma EV concentration correlated with malignanc y grade and extent of peritumoral edema. Postoperatively, EV counts dropped to normal levels, and the magnitude of the postoperative decrease was associated with extent of tumor resection. Methylation profiling of EV-DNA allowed correct tumor classification as meningioma in all investigated cases, and accurate methylation subclass assignment in almost all cases. Copy number variations present in tumors, as well as tumor-specific mutations were faithfully reflected in meningioma EV-DNA. Proteomic EV profiling did not permit original tumor identification but revealed tumor-associated proteins that could potentially be utilized to enrich meningioma EVs from biofluids. Conclusions Elevated EV levels in meningioma patient plasma could aid in tumor diagnosis and assessment of treatment response. Meningioma EV-DNA mirrors genetic and epigenetic tumor alterations and facilitates molecular tumor classification. View on Web

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