Dataset Information

Effect of Antimicrobial Prophylaxis Duration on Health Care-Associated Infections After Clean Orthopedic Surgery: A Cluster Randomized Trial.

ABSTRACT:

Importance

Postoperative health care-associated infections are associated with a greater deterioration in patients' general health status and social and economic burden, with at least 1 occurring in approximately 4% of acute care hospital patients. Antimicrobial prophylaxis prevents surgical site infections in various orthopedic procedures; however, its relationship with health care-associated infections remains unknown.

Objective

To examine whether a shorter antimicrobial prophylaxis duration of less than 24 hours after surgery is not inferior to a longer duration in preventing health care-associated infections after clean orthopedic surgery.

Design, setting, and participants

This open-label, multicenter, cluster randomized, noninferiority clinical trial was conducted in 5 tertiary referral hospitals in greater Tokyo metropolitan area, Japan, from May to December 2018. Adult patients undergoing clean orthopedic surgery were recruited until the planned number of participants was achieved (500 participants per group). Statistical analysis was conducted from July to December 2019.

Interventions

Antimicrobial prophylaxis was discontinued within 24 hours after surgery in group 24 and 24 to 48 hours after surgery in group 48. Group allocation was switched every 2 or 4 months according to the facility-based cluster rule. Study-group assignments were masked from participants.

Main outcomes and measures

The primary outcome was the incidence of health care-associated infections requiring antibiotic therapies within 30 days after surgery. The noninferiority margin was 4%.

Results

Of the 1211 participants who underwent cluster allocation, 633 participants were in group 24 (median [IQR] age, 73 [61-80] years; 250 men [39.5%] and 383 women [60.5%]), 578 participants were in group 48 (median [IQR] age, 74 [62-81] years; 204 men [35.3%] and 374 women [64.7%]), and all were eligible for the intention-to-treat analyses. Health care-associated infections occurred in 29 patients (4.6%) in group 24 and 38 patients (6.6%) in group 48. Intention-to-treat analyses showed a risk difference of -1.99 percentage points (95% CI, -5.05 to 1.06 percentage points; P < .001 for noninferiority) between groups, indicating noninferiority. Results of adjusted intention-to-treat, per-protocol, and per designated procedure population analyses supported this result, without a risk of antibiotic resistance and prolonged hospitalization.

Conclusions and relevance

This cluster randomized trial found noninferiority of a shorter antimicrobial prophylaxis duration in preventing health care-associated infections without an increase in antibiotic resistance risk. These findings lend support to the global movement against antimicrobial resistance and provide additional information on adequate antimicrobial prophylaxis for clean orthopedic surgery.

Trial registration

Identifier: UMIN000030929.

SUBMITTER: Nagata K

PROVIDER: S-EPMC9006110 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Effect of Antimicrobial Prophylaxis Duration on Health Care-Associated Infections After Clean Orthopedic Surgery: A Cluster Randomized Trial.

Nagata Kosei K Yamada Koji K Shinozaki Tomohiro T Miyazaki Tsuyoshi T Tokimura Fumiaki F Tajiri Yasuhito Y Matsumoto Takuya T Yamakawa Kiyofumi K Oka Hiroyuki H Higashikawa Akiro A Sato Toshihide T Kawano Kenichi K Karita Tatsuro T Koyama Takuya T Hozumi Takahiro T Abe Hiroaki H Hodohara Makoto M Kohata Kazuhiro K Toyonaga Masato M Oshima Yasushi Y Tanaka Sakae S Okazaki Hiroshi H

JAMA network open 20220401 4

<h4>Importance</h4>Postoperative health care-associated infections are associated with a greater deterioration in patients' general health status and social and economic burden, with at least 1 occurring in approximately 4% of acute care hospital patients. Antimicrobial prophylaxis prevents surgical site infections in various orthopedic procedures; however, its relationship with health care-associated infections remains unknown.<h4>Objective</h4>To examine whether a shorter antimicrobial prophyl ...[more]

PMID: 35412627

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Project description:BACKGROUND:This study assessed incidence, risk factors, and outcomes of Staphylococcus aureus infections (SAI) following endoprosthetic hip or knee, or spine surgeries. METHODS:Adult patients with at least one of the selected surgeries from 2012 to 2015 captured in a German sickness fund database were included. SAI were identified using S. aureus-specific ICD-10 codes. Patients with certain prior surgeries and infections were excluded. Cumulative incidence and incidence density of post-surgical SAI were assessed. Risk factors, mortality, healthcare resource utilization and direct costs were compared between SAI and non-SAI groups using multivariable analyses over the 1 year follow-up. RESULTS:Overall, 74,327 patients who underwent a knee (28.6%), hip (39.6%), or spine surgery (31.8%) were included. The majority were female (61.58%), with a mean age of 69.59 years and a mean Charlson Comorbidity Index (CCI) of 2.3. Overall, 1.92% of observed patients (20.20 SAI per 1000 person-years (PY)) experienced a SAI within 1 year of index hospitalization. Knee surgeries were associated with lower SAI risk compared with hip surgeries (Hazard Ratio (HR) = 0.8; p = 0.024), whereas spine surgeries did not differ significantly from hip surgeries. Compared with non-SAI group, the SAI group had on average 4.4 times the number of hospitalizations (3.1 vs. 0.7) and 7.7 times the number of hospital days (53.5 vs. 6.9) excluding the index hospitalization (p < 0.001). One year post-orthopedic mortality was 22.38% in the SAI and 5.31% in the non-SAI group (p < 0.001). The total medical costs were significantly higher in the SAI group compared to non-SAI group (42,834€ vs. 13,781€; p < 0.001). Adjusting for confounders, the SAI group had nearly 2 times the all-cause direct healthcare costs (exp(b) = 1.9; p < 0.001); and 1.72 times higher risk of death (HR = 1.72; p < 0.001). CONCLUSIONS:SAI risk after orthopedic surgeries persists and is associated with significant economic burden and risk of mortality. Hence, risk reduction and prevention methods are of utmost importance.

Project description:BackgroundSurgical site infection (SSI) is a common and serious complication of elective clean orthopedic surgery that can lead to severe adverse outcomes. However, the prognostic efficacy of the current staging systems remains uncertain for patients undergoing elective aseptic orthopedic procedures. This study aimed to identify high-risk factors independently associated with SSI and develop a nomogram prediction model to accurately predict the occurrence of SSI.MethodsA total of 20,960 patients underwent elective clean orthopedic surgery in our hospital between January 2020 and December 2021, of whom 39 developed SSI; we selected all 39 patients with a postoperative diagnosis of SSI and 305 patients who did not develop postoperative SSI for the final analysis. The patients were randomly divided into training and validation cohorts in a 7:3 ratio. Univariate and multivariate logistic regression analyses were conducted in the training cohort to screen for independent risk factors of SSI, and a nomogram prediction model was developed. The predictive performance of the nomogram was compared with that of the National Nosocomial Infections Surveillance (NNIS) system. Decision curve analysis (DCA) was used to assess the clinical decision-making value of the nomogram.ResultsThe SSI incidence was 0.186%. Univariate and multivariate logistic regression analysis identified the American Society of Anesthesiology (ASA) class (odds ratio [OR] 1.564 [95% confidence interval (CI) 1.029-5.99, P = 0.046]), operative time (OR 1.003 [95% CI 1.006-1.019, P < 0.001]), and D-dimer level (OR 1.055 [95% CI 1.022-1.29, P = 0.046]) as risk factors for postoperative SSI. We constructed a nomogram prediction model based on these independent risk factors. In the training and validation cohorts, our predictive model had concordance indices (C-indices) of 0.777 (95% CI 0.672-0.882) and 0.732 (95% CI 0.603-0.861), respectively, both of which were superior to the C-indices of the NNIS system (0.668 and 0.543, respectively). Calibration curves and DCA confirmed that our nomogram model had good consistency and clinical predictive value, respectively.ConclusionsOperative time, ASA class, and D-dimer levels are important clinical predictive indicators of postoperative SSI in patients undergoing elective clean orthopedic surgery. The nomogram predictive model based on the three clinical features demonstrated strong predictive performance, calibration capabilities, and clinical decision-making abilities for SSI.

Project description:ImportanceThe benefits of antimicrobial prophylaxis are limited to the first 24 hours postoperatively. Little is known about the harms associated with continuing antimicrobial prophylaxis after skin closure.ObjectiveTo characterize the association of type and duration of prophylaxis with surgical site infection (SSI), acute kidney injury (AKI), and Clostridium difficile infection.Design, setting, and participantsIn this multicenter, national retrospective cohort study, all patients within the national Veterans Affairs health care system who underwent cardiac, orthopedic total joint replacement, colorectal, and vascular procedures and who received planned manual review by a trained nurse reviewer for type and duration of surgical prophylaxis and for SSI from October 1, 2008, to September 30, 2013, were included. Data were analyzed using multivariable logistic regression, with adjustments for covariates determined a priori to be associated with the outcomes of interest. Data were analyzed from December 2016 to December 2018.ExposuresDuration of postoperative antimicrobial prophylaxis (<24 hours, 24-<48 hours, 48-<72 hours, and ≥72 hours).Main outcomes and measuresSurgical site infection, AKI, and C difficile infection.ResultsOf the 79 058 included patients, 76 109 (96.3%) were men, and the mean (SD) age was 64.8 (9.4) years. Among 79 058 surgical procedures in the cohort, all had SSI and C difficile outcome data available; 71 344 (90.2%) had AKI outcome data. After stratification by type of surgery and adjustment for age, sex, race, diabetes, smoking, American Society of Anesthesiologists score greater than 2, methicillin-resistant Staphylococcus aureus colonization, mupirocin, type of prophylaxis, and facility factors, SSI was not associated with duration of prophylaxis. Adjusted odds of AKI increased with each additional day of prophylaxis (cardiac procedure: 24-<48 hours: adjusted odds ratio [aOR], 1.03; 95% CI, 0.95-1.12; 48-<72 hours: aOR, 1.22; 95% CI, 1.08-1.39; ≥72 hours: aOR, 1.82; 95% CI, 1.54-2.16; noncardiac procedure: 24-<48 hours: aOR, 1.31; 95% CI, 1.21-1.42; 48-<72 hours: aOR, 1.72; 95% CI, 1.47-2.01; ≥72 hours: aOR, 1.79; 95% CI, 1.27-2.53). The risk of postoperative C difficile infection demonstrated a similar duration-dependent association (24-<48 hours: aOR 1.08; 95% CI, 0.89-1.31; 48-<72 hours: aOR, 2.43; 95% CI, 1.80-3.27; ≥72 hours: aOR, 3.65; 95% CI, 2.40-5.53). The unadjusted numbers needed to harm for AKI after 24 to less than 48 hours, 48 to less than 72 hours, and 72 hours or more of postoperative prophylaxis were 9, 6, and 4, respectively; and 2000, 90, and 50 for C difficile infection, respectively. Vancomycin receipt was also a significant risk factor for AKI (cardiac procedure: aOR, 1.17; 95% CI, 1.10-1.25; noncardiac procedure: aOR, 1.21; 95% CI, 1.13-1.30).Conclusions and relevanceIncreasing duration of antimicrobial prophylaxis was associated with higher odds of AKI and C difficile infection in a duration-dependent fashion; extended duration did not lead to additional SSI reduction. These findings highlight the notion that every day matters and suggest that stewardship efforts to limit duration of prophylaxis have the potential to reduce adverse events without increasing SSI.

Dataset Information

Effect of Antimicrobial Prophylaxis Duration on Health Care-Associated Infections After Clean Orthopedic Surgery: A Cluster Randomized Trial.

Importance

Objective

Design, setting, and participants

Interventions

Main outcomes and measures

Results

Conclusions and relevance

Trial registration

Publications

Effect of Antimicrobial Prophylaxis Duration on Health Care-Associated Infections After Clean Orthopedic Surgery: A Cluster Randomized Trial.

Similar Datasets

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