INTRODUCTION:Surgical site infections (SSIs) are a leading cause of healthcare-associated infections, particularly in abdominal surgery. In patients allergic to beta-lactams, gentamicin is often used for surgical antibiotic prophylaxis (SAP), but its efficacy is questioned due to limited tissue-level pharmacokinetic/pharmacodynamic (PK/PD) data. MATERIALS AND METHODS:We conducted a monocentric prospective study involving eight adult patients undergoing major abdominal surgery who received gentamicin (5 mg/kg IV) for SAP. Subcutaneous unbound gentamicin concentrations were measured using microdialysis over 6 h. Plasma and tissue PKs were analysed using nonlinear mixed-effects modelling. Monte Carlo simulations assessed the probability of target attainment (PTA) for Cmax/MIC >8 at doses of 5 and 8 mg/kg, using EUCAST MIC distributions for Escherichia coli and Staphylococcus aureus. RESULTS:A total of 246 samples were collected (100 plasma and 146 microdialysate). Subcutaneous gentamicin concentrations were lower than plasma concentrations throughout the 0-6 h interval. Mean Cmax values were 43.7 ± 4.5 mg/L in plasma and 17.8 ± 11.5 mg/L in subcutaneous tissue. Given the lack of defined tissue PK/PD targets in surgical prophylaxis, a plasma-based Cmax/MIC > 8 target was used for PTA simulations. At 5 mg/kg, PTA was suboptimal for MIC ≥1 mg/L in subcutaneous tissue. Simulations showed that increasing the dose to 8 mg/kg improved the cumulative fraction of response against E. coli and S. aureus from 70% and 79% to 80% and 87%, respectively. DISCUSSION:This study highlights insufficient subcutaneous gentamicin exposure with standard SAP dosing. An 8 mg/kg dose improved tissue PK/PD target attainment, supporting updated dosing recommendations for beta-lactam-allergic patients. Further research is needed to validate safety and efficacy in broader populations.

Les infections du site opératoire (ISO) représentent la troisième cause d’infection associée aux soins, avec un impact majeur sur la morbi-mortalité, la durée d’hospitalisation et les coûts de santé. Près de 60 % de ces infections pourraient être évitées par l’application rigoureuse de mesures d’asepsie et d’antisepsie, selon l’Organisation mondiale de la santé (OMS) et l’European Centre for Disease Prevention and Control (ECDC). L’asepsie au bloc opératoire repose sur un ensemble coordonné de mesures structurelles, comportementales et techniques visant à prévenir toute contamination endogène ou exogène. Les recommandations récentes de la Société française d’hygiène hospitalière (SF2H), de la Société française d’anesthésie et de réanimation (SFAR) et de l’OMS insistent sur une approche intégrée englobant la préparation du patient, la maîtrise de l’environnement opératoire, la formation du personnel et la gestion dynamique du risque infectieux. Les bonnes pratiques incluent la limitation du trafic en salle, le contrôle périodique de la qualité de l’air, l’hygiène rigoureuse des mains, la préparation cutanée selon les protocoles validés et la décolonisation ciblée des porteurs de Staphylococcus aureus. Les solutions alcooliques, et en particulier la chlorhexidine à 2 %, sont recommandées en première intention pour la préparation cutanée avant chirurgie propre ou propre-contaminée. La povidone iodée alcoolique demeure une option pertinente en chirurgie. La gestion des patients en isolement (bactérie multirésistante BMR, bactérie hautement résistante émergente BHRe, tuberculose, SARS-CoV-2) nécessite une organisation spécifique du bloc opératoire, associant équipe dédiée, équipement de protection individuelle adapté et procédures de désinfection terminale. L’asepsie n’est pas un geste isolé mais une culture partagée, fondée sur la rigueur, la formation et la responsabilité collective de l’ensemble de l’équipe périopératoire.

BACKGROUND:Surgical site infections (SSI) are among the most frequently observed healthcare associated infections and represent a significant target to reduce the impact of antimicrobial resistance. Use of a surgical care bundle has demonstrated efficacy in reduction in SSI, but there is a lack of consensus on which elements should be included within such a bundle. The aim of this international consensus was to determine what factors should be utilized to produce an optimal, evidence-led bundle of care that can be utilized in a multidisciplinary manner across specialties and across countries. METHODS:The process employed a modified Delphi methodology. Based on published high-level evidence an international multidisciplinary steering group developed 38 statements for testing with a wider responder panel of healthcare professionals in Europe. The threshold for consensus agreement was set at 75%. RESULTS:A total of 820 responses were analyzed, with the majority of participants being surgeons (59%) and nurses (19.1%) from across Europe. The consensus process evaluated 36 finalized statements covering preoperative, intraoperative, and postoperative SSI prevention practices. Overall, 33 out of 36 statements (92%) reached the predefined consensus threshold of 75% agreement. A high agreement was observed across multiple roles and specialties, although some variation existed for specific topics such as antiseptic irrigation, use of antimicrobial sutures, and plastic adhesive drapes. CONCLUSION:This large consensus of European HCPs involved in the surgical care of patients achieved strong levels of consensus across most of the proposed statements on elements of an SSI prevention bundle. These practice recommendations could be adopted as an evidence- and expert-based care bundle for the prevention of SSI. The project was registered at www.researchregistry.com.

Introduction Upper aerodigestive tract endoscopy is routinely performed for the diagnosis and staging of head and neck cancers. These procedures are commonly conducted under general anaesthesia with spontaneous ventilation to optimise surgical exposure and avoid tracheal intubation. However, maintaining adequate oxygenation remains challenging, particularly in patients with altered airway anatomy due to prior surgery or radiotherapy.Standard practice often involves a preliminary laryngoscopy to insert a nasopharyngeal oxygen catheter, which may increase procedural complexity and interfere with surgical conditions. High-flow nasal oxygen (HFNO) has emerged as a promising alternative for maintaining oxygenation in various perioperative settings.The OPTIGO trial aims to determine whether HFNO is non-inferior to nasopharyngeal oxygen insufflation in preventing intraoperative oxygen desaturation during upper aerodigestive tract endoscopy.Methods and analysis The OPTIGO study is a multicentre, prospective, randomised, open-label, non-inferiority trial conducted in three French centres. A total of 610 adult patients scheduled for endoscopic procedures of the pharynx, larynx and oesophagus will be randomised in a 1:1 ratio to receive either HFNO or standard oxygenation via a nasopharyngeal oxygen catheter.The primary outcome is the occurrence of intraoperative oxygen desaturation, defined as a peripheral oxygen saturation ≤85% at any time from induction to the end of the procedure.Secondary outcomes include intraoperative complications, postoperative laryngeal pain, surgeon comfort, duration of the procedure, anaesthetic drug consumption, and perioperative gas exchange.Ethics and dissemination This study has been approved by the independent ethics committee CPP Est 1 (10 April 2025; EudraCT 2025-A00278-41). The trial will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice Guidelines.Results will be disseminated through presentations at scientific conferences and publication in peer-reviewed journals.Trial registration number CPP Est 1 EudraCT 2025-A00278-41 (Clinical trial NCT07004699).

IntroductionTechniques for measuring digestive motility are becoming increasingly precise and enable therapeutic interventions. However, while most of these interventions require general anesthesia, there is limited data on the impact of anesthetic agents on these measurements, and no standardized anesthesia protocol currently exists to guide such procedures. Our working group carried out two Delphi processes involving experts in neurogastroenterology and anesthesiology to reach a consensus on which drugs affect these measurements and to establish an anesthesia protocol.MethodTwo expert groups were formed, comprising 13 neurogastroenterology experts from the French Neuro-Gastroenterology Group (GFNG) and 15 full- or associate professors in anesthesia and intensive care. The first Delphi process involved the neurogastroenterologists and aimed to identify which anesthetic drugs influenced digestive pressure measurements. The second Delphi process, involving anesthetists, sought to develop an anesthesia protocol. Each expert indicated their level of agreement with each statement using a 6-point Likert scale. A statement was endorsed when at least 80% of experts agreed with it. The strength of evidence for each statement was evaluated using the GRADE system.ResultsThe Delphi process with neurogastroenterologists was conducted over three rounds and ultimately resulted in 91 amendments. The second Delphi process with anesthetists took place over two rounds and included 28 amendments, leading to the development of an anesthesia protocol.ConclusionTo our knowledge, this work is the first to establish an expert consensus on anesthetic agents that can affect digestive motility measurements and to propose an anesthesia protocol that accounts for the needs of neurogastroenterologists.

Introduction Surgical site infections (SSIs) are the second leading cause of healthcare-associated infections in Europe with the highest rates being reported in colorectal surgery (ranging from 9% to 30%). Surgical antibiotic prophylaxis (SAP) is one of the most efficient measures for SSI prevention and should be started before surgical incision. Cefoxitin is an antibiotic widely used as SAP for colorectal surgery, but its continuous administration is currently the subject of debate due to its potential pharmacokinetic advantages. Therefore, the aim of the PROPHYLOXITIN study is to demonstrate that a loading dose followed by continuous infusion of cefoxitin during colorectal surgery (intervention group) decreases the rate of SSI compared to an intermittent bolus administration (control group).Methods and analysis The PROPHYLOXITIN study is a superiority, prospective, double-blind, randomised and multicentre study of 2000 patients undergoing colorectal surgery. The primary objective is to demonstrate the superiority of a loading dose of cefoxitin followed by continuous infusion over intermittent bolus administration in reducing the proportion of SSIs within 30 days after colorectal surgery. Subjects will be randomised 1:1 using a secure web-based random-number generator to one of two study groups. Randomised allocation of treatment will be done by minimisation and stratified according to the centre, the localisation of surgery (colon or rectum) and the type of surgical procedure (laparoscopy or laparotomy).Ethics and dissemination This research has been approved by an independent ethics committee and will be carried out according to the principles of the Declaration of Helsinki and the Good Clinical Practice guidelines. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.Trial registration number EudraCT 2022-003262-20 and Clinical trial NCT05755789.

Patients with a penicillin allergy label have an increased risk of surgical site infection. Although a decision tree was published in 2019 to define which patients could benefit from direct cephalosporin use in the perioperative setting, this strategy remains unvalidated. This consensus statement aimed to adapt it based on an expert consensus to cover persisting caveats and to adapt it to an environment with poor allergist resources. Perioperative antibiotic prophylaxis and allergy experts were invited to participate. The Delphi method was implemented using an online-secured network. The panellists were given 3 weeks to answer each round. A consensus was reached if more than 75% of the experts rated the item ≥ 7 and if less than 25% rated the item ≤ 3. Sixteen experts participated. A high level of agreement was obtained after four rounds, defining four categories of the index reaction: unknown, not compatible, or compatible with an immediate or delayed hypersensitivity reaction. Twelve items were defined to stratify the risk of true penicillin allergy according to the index reaction history. The experts agreed that patients with high-risk reactions could benefit from either an allergy work-up or beta-lactam alternatives use. Those at low risk could benefit from direct cephalosporin administration. This resulted in an adapted decision tree to promote cephalosporin prescription in patients with penicillin allergy labels. It will be used in a stepped-wedge prospective multicentric randomized study to assess its applicability and acceptability to promote first- and second-generation cephalosporin administration in the perioperative period.

Surgical site infections (SSIs) are among the most common healthcare-associated infections, leading to increased morbidity, prolonged hospital stays, and significant healthcare costs. Surgical antimicrobial prophylaxis (SAP) is a critical strategy for SSI prevention, yet its effectiveness is threatened by antimicrobial resistance and variability in clinical practice. This narrative review provides an evidence-based update on the pathophysiology of SSIs, highlighting the interplay between endogenous microbiota, surgical stress, and perioperative factors such as hypoxia, immune modulation, and microbiome disruption. The current state-of-the-art in SAP is reviewed, including antibiotic selection, timing, dosing, intraoperative redosing, and the avoidance of unnecessary postoperative administration. Key intra- and postoperative measures to reduce the risk of SSI are covered, including glycaemic control, body temperature management, goal-directed fluid therapy, and skin antisepsis. A critical appraisal of the supporting evidence is included, with emphasis on areas of ongoing debate. The final section outlines future research priorities: optimizing dosing in obese patients, evaluating continuous infusion, tailoring prophylaxis to surgical site and microbiome, and addressing the management of patients colonized with multidrug-resistant organisms. Non-antibiotic strategies and rapid diagnostic tests are also discussed as promising avenues to enhance precision in infection prevention. By integrating current knowledge with emerging perspectives, this review aims to support the refinement of SSI prevention strategies and contribute to antimicrobial stewardship in modern surgical practice.

Background: Stress due to surgical trauma decreases postoperative lymphocyte counts (LCs), potentially favouring the occurrence of postoperative infections (PIs). Objectives: We aimed to determine whether postoperative lymphopaenia following thoracic or gastrointestinal cancer surgery is an independent risk factor for PIs and to identify modifiable factors related to anaesthesia and surgical procedures that might affect its occurrence. Study design: The EVALYMPH study was a prospective, multicentre cohort study with a 30-day patient follow-up. Multivariate analyses were performed to determine the risk factors for PIs and for postoperative lymphopaenia. Setting: Patients were included from January 2016 to September 2017 in 25 French centres. Patients: Adult patients admitted for thoracic or gastrointestinal cancer surgery were eligible for inclusion. Main outcome measure: PIs within 30 days after surgery were defined as urinary tract infections, pneumonia, surgical site infections and other infections (bloodstream infections or pleurisy). Results: Of 1207 patients included, 273 (22.6%) developed at least one infection within 30 days after surgery, with a median [IQR] time to onset of 8 [5 to 11] days. An increased risk of PI was significantly associated with an ASA score of IV: hazard ratio (HR) 4.27 (95% confidence interval (CI), 1.87 to 9.72), surgery > 200 min (HR 1.58 (1.15 to 2.17) and lymphopaenia on postoperative day 1 (POD1) (HR 1.56 (1.08 to 2.25). This risk was associated with changes in postoperative LC over time ( P = 0.001) but not with preoperative LC ( P = 0.536).POD1 lymphopenia was related to patient characteristics and duration of surgery but not to potentially modifiable other surgical or anaesthetics factors. Conclusions: POD1 lymphopaenia was associated with PIs in patients undergoing thoracic or gastrointestinal cancer surgery. To individualise care, patient characteristics and surgery duration should be taken into account.

PurposeWhether skin disinfection of the surgical site using chlorhexidine-alcohol is superior to povidone-iodine-alcohol in reducing reoperation and surgical site infection rates after major cardiac surgery remains unclear.MethodsCLEAN 2 was a multicenter, open-label, randomized, two-arm, assessor-blind, superiority trial conducted in eight French hospitals. We randomly assigned adult patients undergoing major heart or aortic surgery via sternotomy, with or without saphenous vein or radial artery harvesting, to have all surgical sites disinfected with either 2% chlorhexidine-alcohol or 5% povidone-iodine-alcohol. The primary outcome was any resternotomy by day 90 or any reoperation at the peripheral surgical site by day 30.ResultsOf 3242 patients (1621 in the chlorhexidine-alcohol group [median age, 69 years; 1276 (78.7%) men] and 1621 in the povidone-iodine-alcohol group [median age, 69 years; 1247 (76.9%) men], the percentage required reoperation within 90 days was similar (7.7% [125/1621] in the chlorhexidine-alcohol group vs 7.5% [121/1621] in the povidone-iodine-alcohol group; risk difference, 0.25 [95% confidence interval (CI), - 1.58-2.07], P = 0.79). The incidence of surgical site infections at the sternum or peripheral sites was similar (4% [65/1621] in the chlorhexidine-alcohol group vs 3.3% [53/1621] in the povidone-iodine-alcohol group; risk difference, 0.74 [95% CI - 0.55-2.03], P = 0.26). Length of hospital stay, intensive care unit or hospital readmission, mortality and surgical site adverse events were similar between the two groups.ConclusionAmong patients requiring sternotomy for major heart or aortic surgery, skin disinfection at the surgical site using chlorhexidine-alcohol was not superior to povidone-iodine-alcohol for reducing reoperation and surgical site infection rates.

Importance:Before surgery, the best strategy for managing patients who are taking renin-angiotensin system inhibitors (RASIs) (angiotensin-converting enzyme inhibitors or angiotensin receptor blockers) is unknown. The lack of evidence leads to conflicting guidelines. Objective:To evaluate whether a continuation strategy vs a discontinuation strategy of RASIs before major noncardiac surgery results in decreased complications at 28 days after surgery. Design, Setting, and Participants:Randomized clinical trial that included patients who were being treated with a RASI for at least 3 months and were scheduled to undergo a major noncardiac surgery between January 2018 and April 2023 at 40 hospitals in France. Intervention:Patients were randomized to continue use of RASIs (n = 1107) until the day of surgery or to discontinue use of RASIs 48 hours prior to surgery (ie, they would take the last dose 3 days before surgery) (n = 1115). Main Outcomes and Measures:The primary outcome was a composite of all-cause mortality and major postoperative complications within 28 days after surgery. The key secondary outcomes were episodes of hypotension during surgery, acute kidney injury, postoperative organ failure, and length of stay in the hospital and intensive care unit during the 28 days after surgery. Results:Of the 2222 patients (mean age, 67 years [SD, 10 years]; 65% were male), 46% were being treated with angiotensin-converting enzyme inhibitors at baseline and 54% were being treated with angiotensin receptor blockers. The rate of all-cause mortality and major postoperative complications was 22% (245 of 1115 patients) in the RASI discontinuation group and 22% (247 of 1107 patients) in the RASI continuation group (risk ratio, 1.02 [95% CI, 0.87-1.19]; P = .85). Episodes of hypotension during surgery occurred in 41% of the patients in the RASI discontinuation group and in 54% of the patients in the RASI continuation group (risk ratio, 1.31 [95% CI, 1.19-1.44]). There were no other differences in the trial outcomes. Conclusions and Relevance:Among patients who underwent major noncardiac surgery, a continuation strategy of RASIs before surgery was not associated with a higher rate of postoperative complications than a discontinuation strategy. Trial Registration:ClinicalTrials.gov Identifier: NCT03374449.

BACKGROUND Stress due to surgical trauma decreases postoperative lymphocyte counts (LCs), potentially favouring the occurrence of postoperative infections (PIs). OBJECTIVES We aimed to determine whether postoperative lymphopaenia following thoracic or gastrointestinal cancer surgery is an independent risk factor for PIs and to identify modifiable factors related to anaesthesia and surgical procedures that might affect its occurrence. STUDY DESIGN The EVALYMPH study was a prospective, multicentre cohort study with a 30-day patient follow-up. Multivariate analyses were performed to determine the risk factors for PIs and for postoperative lymphopaenia. SETTING Patients were included from January 2016 to September 2017 in 25 French centres. PATIENTS Adult patients admitted for thoracic or gastrointestinal cancer surgery were eligible for inclusion. MAIN OUTCOME MEASURE PIs within 30 days after surgery were defined as urinary tract infections, pneumonia, surgical site infections and other infections (bloodstream infections or pleurisy). RESULTS Of 1207 patients included, 273 (22.6%) developed at least one infection within 30 days after surgery, with a median [IQR] time to onset of 8 [5 to 11] days. An increased risk of PI was significantly associated with an ASA score of IV: hazard ratio (HR) 4.27 (95% confidence interval (CI), 1.87 to 9.72), surgery > 200 min (HR 1.58 (1.15 to 2.17) and lymphopaenia on postoperative day 1 (POD1) (HR 1.56 (1.08 to 2.25). This risk was associated with changes in postoperative LC over time (P = 0.001) but not with preoperative LC (P = 0.536). POD1 lymphopenia was related to patient characteristics and duration of surgery but not to potentially modifiable other surgical or anaesthetics factors. CONCLUSIONS POD1 lymphopaenia was associated with PIs in patients undergoing thoracic or gastrointestinal cancer surgery. To individualise care, patient characteristics and surgery duration should be taken into account. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02799251

Les infections du site opératoire représentent la troisième cause d’infections associées aux soins en France et sont associées à une morbi-mortalité élevée. L’antibioprophylaxie est indiquée pour les chirurgies à haut risque d’infections du site opératoire, notamment celles exposant le site opératoire à l’ouverture du tractus digestif, du tractus respiratoire ou urogénital. Elle fait l’objet de recommandations générales communes à l’ensemble des spécialités chirurgicales et de recommandations spécifiques à chaque intervention. Sa réalisation repose sur quatre piliers : la bonne indication, le choix de la molécule, la bonne posologie et le moment adéquat. Pour les patients allergiques à la pénicilline, des protocoles de seconde intention doivent être mis en place, en veillant à la confirmation de l’allergie par des tests allergologiques. L’antibioprophylaxie est une stratégie efficace mais sa réalisation nécessite le respect des protocoles établis afin de minimiser les risques d’effets indésirables et d’assurer une protection optimale contre les infections du site opératoire.

BACKGROUND:Patients with acute brain injury are at high risk of ventilator-associated pneumonia (VAP). The benefit of short-term antibiotic prophylaxis remains debated. We aimed to establish the effect of an early, single dose of the antibiotic ceftriaxone on the incidence of early VAP in patients with severe brain injury who required mechanical ventilation. METHODS:PROPHY-VAP was a multicentre, randomised, double-blind, placebo-controlled, assessor-masked, superiority trial conducted in nine intensive care units in eight French university hospitals. We randomly assigned comatose (Glasgow Coma Scale score [GCS] ≤12) adult patients (age ≥18 years) who required mechanical ventilation for at least 48 h after acute brain injury to receive intravenous ceftriaxone 2 g or placebo once within the 12 h following tracheal intubation. Participants did not receive selective oropharyngeal and digestive tract decontamination. The primary outcome was the proportion of patients developing early VAP from the 2nd to the 7th day of mechanical ventilation, confirmed by masked assessors. The analysis was reported in the modified intention-to-treat population, which comprised all randomly assigned patients except those who withdrew or did not give consent to continue and those who did not receive the allocated treatment because they met a criterion for non-eligibility. The trial is registered with ClinicalTrials.gov, NCT02265406. FINDINGS:From Oct 14, 2015, to May 27, 2020, 345 patients were randomly assigned (1:1) to receive ceftriaxone (n=171) or placebo (n=174); 330 received the allocated intervention and 319 were included in the analysis (162 in the ceftriaxone group and 157 in the placebo group). 166 (52%) participants in the analysis were men and 153 (48%) were women. 15 patients did not receive the allocated intervention after randomisation and 11 withdrew their consent. Adjudication confirmed 93 cases of VAP, including 74 early infections. The incidence of early VAP was lower in the ceftriaxone group than in the placebo group (23 [14%] vs 51 [32%]; hazard ratio 0·60 [95% CI 0·38-0·95], p=0·030), with no microbiological impact and no adverse effects attributable to ceftriaxone. INTERPRETATION:In patients with acute brain injury, a single ceftriaxone dose decreased the risk of early VAP. On the basis of our findings, we recommend that an early, single dose of ceftriaxone be included in all bundles for the prevention of VAP in patients with brain injury who require mechanical ventilation. FUNDING:French Ministry of Social Affairs and Health.

Although uncommon, infections associated with peripheral intravenous catheters (PIVCs) may be responsible for severe life-threatening complications and increase healthcare costs. Few data are available on the relationship between PIVC insertion site and risk of infectious complications. We performed a post hoc analysis of the CLEAN 3 database, a randomized 2 × 2 factorial study comparing two skin disinfection procedures (2

Surgical site infections are the third leading cause of healthcare -associated infections in France and are associated with high morbidity and mortality. Surgical antibiotic prophylaxis is indicated for high -risk surgical procedures, particularly those involving the opening of the digestive, respiratory, or urogenital tracts. It is guided by general recommendations applicable to all surgical specialities and speci fi c recommendations for each type of surgery. The implementation of surgical antibiotic prophylaxis is based on four key pillars: appropriate indication, the choice of the antibiotic agent, the correct dosage, and the optimal timing. For patients allergic to penicillin, second -line protocols should be implemented, with con fi rmation of the allergy through allergo- logical testing. Surgical antibiotic prophylaxis is an effective strategy, but its execution requires strict adherence to established protocols to minimize the risk of adverse effects and ensure optimal protection against surgical site infections.