Benefits and harms of perioperative high fraction inspired oxygen for surgical site infection prevention: a protocol for a systematic review and meta-analysis of individual patient data of randomised controlled trials.

INTRODUCTION: The use of high fraction of inspired oxygen (FiO2) intraoperatively for the prevention of surgical site infection (SSI) remains controversial. Promising results of early randomised controlled trials (RCT) have been replicated with varying success and subsequent meta-analysis are equivocal. Recent advancements in perioperative care, including the increased use of laparoscopic surgery and pneumoperitoneum and shifts in fluid and temperature management, can affect peripheral oxygen delivery and may explain the inconsistency in reproducibility. However, the published data provides insufficient detail on the participant level to test these hypotheses. The purpose of this individual participant data meta-analysis is to assess the described benefits and harms of intraoperative high FiO2compared with regular (0.21-0.40) FiO2 and its potential effect modifiers. METHODS AND ANALYSIS: Two reviewers will search medical databases and online trial registries, including MEDLINE, Embase, CENTRAL, CINAHL, ClinicalTrials.gov and WHO regional databases, for randomised and quasi-RCT comparing the effect of intraoperative high FiO2 (0.60-1.00) to regular FiO2 (0.21-0.40) on SSI within 90 days after surgery in adult patients. Secondary outcome will be all-cause mortality within the longest available follow-up. Investigators of the identified trials will be invited to collaborate. Data will be analysed with the one-step approach using the generalised linear mixed model framework and the statistical model appropriate for the type of outcome being analysed (logistic and cox regression, respectively), with a random treatment effect term to account for the clustering of patients within studies. The bias will be assessed using the Cochrane risk-of-bias tool for randomised trials V.2 and the certainty of evidence using Grading of Recommendations, Assessment, Development and Evaluation methodology. Prespecified subgroup analyses include use of mechanical ventilation, nitrous oxide, preoperative antibiotic prophylaxis, temperature (<35°C), fluid supplementation (<15 mL/kg/hour) and procedure duration (>2.5 hour). ETHICS AND DISSEMINATION: Ethics approval is not required. Investigators will deidentify individual participant data before it is shared. The results will be submitted to a peer-review journal. PROSPERO REGISTRATION NUMBER: CRD42018090261.

General practitioners' clinical practice on the management of cystitis in Normandy, France: A clinical vignettes-based study.

RATIONALE, AIMS, AND OBJECTIVES: The objective was to measure the quality of clinical practice for the management of cystitis in adult women in general practice by collaborating with quality circles and the regional centre for antibiotic counsel. METHOD: This descriptive cross-sectional study was performed in 2018 in Normandy, France. A questionnaire composed of clinical vignettes was used to evaluate practices of general practitioners (GPs) with regard to cystitis classified into four categories: simple, at risk of complication, recurrent, and caused by multidrug-resistant bacteria. The 2017 French Infectious Diseases Society's guidelines were used as a reference. RESULTS: A total of 142 GPs participated in the study (45.5% of the solicited). Fosfomycin-trometamol and pivmecillinam were cited as first-line treatments for simple cystitis by 134 (94%) and 38 (27%) participants, respectively. For at risk of complication cystitis, the treatments cited were cefixime by 64 participants (45%), ofloxacin by 50 (35%), pivmecillinam by 49 (35%), fosfomycin-trometamol by 38 (27%), nitrofurantoin by 36 (25%), and amoxicillin-clavulanic acid by 28 (20%). Mean compliance rates were 85% for simple cystitis, 39% for at risk of complication cystitis, 60% for recurrent cystitis and 14% for cystitis caused by multidrug-resistant bacteria. Two criteria had less than 10% of the compliant answers: comprehensive knowledge of cystitis complication risk factors (9%) and positivity thresholds of urine cultures (10%). CONCLUSIONS: In this study, diagnostic means, follow-up testing, and simple cystitis treatment (with fosfomycin predominantly mentioned) were broadly compliant. The use of critical antibiotics was too frequent for at risk of complication cystitis. There may be a need to improve the knowledge of professionals on antibiotic resistance and appropriate antibiotic use.

Hemodialysis in satellite dialysis units: incidence of patient fallback to the in-center dialysis unit.

BACKGROUND: Patient fallbacks occur when a patient treated in a satellite dialysis unit (SDU) must be transferred to an in-center dialysis unit. Fallbacks have an impact on the in-center dialysis unit organization. This study was carried out to estimate the incidence and risk factors of patient fallback. METHODS: Between 01/01/2006 and 31/12/2010 there were 193 patients starting dialysis in SDUs in one French region. The primary outcome was the incidence of temporary and permanent fallbacks with or without hospitalization. A survival analysis and binomial negative regression were used for the statistical analysis. RESULTS: Among the 193 patients, 117 (60.6%; 95% confidence interval [CI]: 53.3-67.6) had at least one fallback, which occurred within a median of 249 days (interquartile range [IQR]: 71-469) after the first session in the SDU. The median number of fallbacks by subject was 1 (IQR: 0-4). The median duration of the fallback period was 4 days (IQR: 1-8) and median number of dialysis sessions during the fallback time was 1 (IQR: 1-3). Of the 494 temporary fallbacks, 210 were due to patient hospitalization, the main cause of which was cardiovascular disease. At univariate analysis, patients permanently transferred to in-center hemodialysis units were older, had more peripheral arteriopathy, cancer and arrhythmia. At multivariate analysis, peripheral arteriopathy (relative risk [RR] 2.06, 95% CI 1.05-4.09) and the center (center 2: RR 0.42, 95% CI 0.21-0.84; center 3: RR 2.88, 95% CI 1.20-6.91) were significantly associated with the number of fallbacks. CONCLUSION: Fallback is a common event in hemodialysis patients treated in SDUs. Yet, the SDU system operates well since a third of patients treated in these units are still in SDUs at 2 years of follow-up. Factors associated with patient fallback are the center and cardiovascular disease.

Enterobacteriaceae surgical site infection after cardiac surgery: the hypothetical role of vancomycin.

BACKGROUND: In the middle of October 2011, the Hygiene Department of Caen University Hospital suspected an outbreak of surgical site infections (SSI) after open-heart operations with an unusually high proportion of microorganisms belonging to the Enterobacteriaceae family. The attack rate was 3.8%, significantly different (p = 0.035) from the attack rate of 1.2% in 2010 over the equivalent period. A case-control study was conducted to search specifically for risk factors for Enterobacteriaceae infections after median sternotomy in cardiac patients. METHODS: Case patients were defined retrospectively as patients with superficial or deep surgical site infection with Enterobacteriaceae within 30 days of median sternotomy. Four control patients were selected per case patient from patients matched for date of operation (± 15 days) and European System for Cardiac Operative Risk Evaluation (<5, [5-10], >10). RESULTS: Univariate analysis identified the following risk factors: inappropriate skin preparation on the morning of the intervention (p = 0.046), use of vancomycin (p = 0.030), and number of sternotomy dressings (p = 0.033). A multivariate logistic regression analysis found that vancomycin use was independently associated with an increased risk of postoperative SSI with Enterobacteriaceae (p = 0.019; odds ratio = 7.4). CONCLUSIONS: Although vancomycin is known to be effective for preventing infection with methicillin-sensitive organisms, our results suggest that it was associated with a risk for the development of SSI with gram-negative organisms after median sternotomy. This study led to a multidisciplinary meeting that defined new guidelines for prophylactic antibiotic therapy before open-heart operations.

Effect of perioperative oxygen supplementation on 30-day surgical site infection rate in abdominal, gynecologic, and breast surgery: the ISO2 randomized controlled trial.

BACKGROUND: Benefits and limitations of supplementation with 80% fraction of inspired oxygen for preventing surgical site infections have not yet been clearly defined. Some studies have reported benefits in colorectal surgery, whereas trials in abdominal and gynecologic surgery have reported either no effect or a deleterious effect. METHODS: Controlled, randomized, assessor-blind multicenter trial, the ISO2 study, comparing the effects of hyperoxygenation (fraction of inspired oxygen, 80%) with those of 30% oxygen on the frequency of surgical site infections in routine abdominal, gynecologic, and breast surgery on 434 patients. Patients not seen in consultation after discharge were contacted. RESULTS: In total, 208 patients received 30% perioperative oxygen and 226 received 80%. There was no difference between the two groups for baseline, intraoperative, and postoperative characteristics, except for oxygen saturation at closure, higher in the 80% group (P=0.01). The frequency of 30-day surgical site infections was 7.2% (15/208) in the 30% group and 6.6% (15/226) in the 80% group (relative risk, 0.92; 95% CI [0.46-1.84], P=0.81). Frequency of adverse events (nausea and vomiting, sternal pain, cough, hypotension) was similar in the two groups. Desaturation and bradycardia were more frequent in the 30% group. In an updated meta-analysis including the result of this trial and those of eight published randomized trials, the overall relative risk was 0.97; 95% CI (0.68-1.40), I2 (inconsistency degree)=73%, (P=0.88). CONCLUSIONS: The routine use of hyperoxygenation throughout abdominal, gynecologic, and breast surgery had no effect on the frequency of 30-day surgical site infections and was not accompanied by more frequent adverse effects.

Surgical site infection associated with the use of bovine serum albumine-glutaraldehyde surgical adhesive (BioGlue) in cranial surgery: a case-control study.

PURPOSE: To enhance the water tightness of dura mater closure in cranial surgery, an organic glue called BioGlue was used in our neurosurgical department between January 2006 and June 2007. During this period of time, we noticed an important increase in the surgical site infection (SSI) incidence. We conducted a case-control study to identify risk factors for these infections. Our objective was to test the hypothesis that BioGlue was one of the risk factors. METHODS: Cases with infection were defined retrospectively. We included two controls per case. Study data were age, sex, time of year, in stay hospital preoperative time, length of surgery, type of surgery, surgeon, use of BioGlue, and use of duraplasty. We first performed a univariate analysis and then the significant variables were introduced in a logistic regression model. RESULTS: Thirty patients were defined as cases (60 controls). In multivariate analysis, risk factors were young age (p = 0.04), extended operative length (p = 0.02) and the use of BioGlue (p = 0.007). The combined use of BioGlue and Neuropatch appeared to be a significant risk factor for SSI (p = 0.002). CONCLUSIONS: BioGlue seems to increase the risk of SSI for patients who underwent craniotomy, especially when associated with synthetic dural graft. BioGlue triggers an intense inflammatory response, which causes wound breaches allowing bacteria to spread down in the wound, and then creates an ideal environment for bacterial growth.

Elevated D-dimer level in the differential diagnosis of venous malformations.

OBJECTIVE: To evaluate if elevated D-dimer level is specific for venous malformations (VMs) and thus useful for differential diagnosis, which can be problematic even in specialized interdisciplinary centers. Localized intravascular coagulopathy, characterized by elevated D-dimer levels, has been observed in approximately 40% of patients with VMs. DESIGN: Prospective convenience sample accrued from 2 interdisciplinary sites. SETTING: Two interdisciplinary centers for vascular anomalies in Brussels, Belgium, and Caen, France PARTICIPANTS: The study population comprised 280 patients with clinical data, Doppler ultrasonograms (for 251 patients), and coagulation parameter measurements. Main Outcome Measure Measurement of D-dimer levels. RESULTS: A VM was diagnosed in 195 of 280 patients (69.6%), and 83 of them had elevated D-dimer levels; the sensitivity of D-dimer dosage was 42.6% (95% confidence interval, 35.6%-49.5%). Among the 85 patients without VM, D-dimer levels were elevated only in 3 patients; the specificity of the dosage was 96.5% (95% confidence interval, 92.5%-100%). CONCLUSIONS: Elevated D-dimer level is highly specific for VMs (pure, combined, or syndromic), and therefore this easy and inexpensive biomarker test should become part of the clinical evaluation of vascular anomalies. It can detect hidden VMs and help differentiate glomuvenous malformation (normal D-dimer levels) from other multifocal venous lesions. Elevated D-dimer level also differentiates a VM from a lymphatic malformation. Moreover, slow-flow Klippel-Trenaunay syndrome (capillaro-lymphatico-venous malformation with limb hypertrophy) can be distinguished from fast-flow Parkes Weber syndrome (capillary malformation with underlying multiple microfistulas and limb hypertrophy). For these reasons, D-dimer level measurement is a useful complementary tool for diagnosing vascular anomalies in everyday practice.

Hand-rubbing with an aqueous alcoholic solution vs traditional surgical hand-scrubbing and 30-day surgical site infection rates: a randomized equivalence study.

CONTEXT: Surgical site infections prolong hospital stays, are among the leading nosocomial causes of morbidity, and a source of excess medical costs. Clinical studies comparing the risk of nosocomial infection after different hand antisepsis protocols are scarce. OBJECTIVE: To compare the effectiveness of hand-cleansing protocols in preventing surgical site infections during routine surgical practice. DESIGN: Randomized equivalence trial. SETTING: Six surgical services from teaching and nonteaching hospitals in France. PATIENTS: A total of 4387 consecutive patients who underwent clean and clean-contaminated surgery between January 1, 2000, and May 1, 2001. INTERVENTIONS: Surgical services used 2 hand-cleansing methods alternately every other month: a hand-rubbing protocol with 75% aqueous alcoholic solution containing propanol-1, propanol-2, and mecetronium etilsulfate; and a hand-scrubbing protocol with antiseptic preparation containing 4% povidone iodine or 4% chlorhexidine gluconate. MAIN OUTCOME MEASURES: Thirty-day surgical site infection rates were the primary end point; operating department teams' tolerance of and compliance with hand antisepsis were secondary end points. RESULTS: The 2 protocols were comparable in regard to surgical site infection risk factors. Surgical site infection rates were 55 of 2252 (2.44%) in the hand-rubbing protocol and 53 of 2135 (2.48%) in the hand-scrubbing protocol, for a difference of 0.04% (95% confidence interval, -0.88% to 0.96%). Based on subsets of personnel, compliance with the recommended duration of hand antisepsis was better in the hand-rubbing protocol of the study compared with the hand-scrubbing protocol (44% vs 28%, respectively; P =.008), as was tolerance, with less skin dryness and less skin irritation after aqueous solution use. CONCLUSIONS: Hand-rubbing with aqueous alcoholic solution, preceded by a 1-minute nonantiseptic hand wash before each surgeon's first procedure of the day and before any other procedure if the hands were soiled, was as effective as traditional hand-scrubbing with antiseptic soap in preventing surgical site infections. The hand-rubbing protocol was better tolerated by the surgical teams and improved compliance with hygiene guidelines. Hand-rubbing with liquid aqueous alcoholic solution can thus be safely used as an alternative to traditional surgical hand-scrubbing.