Dataset Information

Determining the worldwide epidemiology of surgical site infections after gastrointestinal resection surgery: protocol for a multicentre, international, prospective cohort study (GlobalSurg 2).

ABSTRACT: INTRODUCTION:Surgical site infection (SSI) is the most common complication following major gastrointestinal surgery, affecting between 25% and 40% of patients. The rate of SSI doubles from low-income to high-income settings, persisting after risk adjustment. The relative impact of antibiotic-resistant organisms and the effectiveness of antibiotic prophylaxis globally are unknown. This study aims to determine SSI rates following gastrointestinal surgery across worldwide hospital settings. METHODS AND ANALYSIS:This multicentre, international, prospective cohort study will be undertaken by any hospital providing emergency or elective gastroenterological surgical services. Centres will collect observational data on consecutive patients undergoing emergency or elective gastrointestinal resection, cholecystectomy or appendicectomy during a 6-month period. The primary outcome is the incidence of SSI with secondary outcomes describing the organisms causing SSIs, including their antibiotic susceptibility, and the microbiological tests used to identify them. ETHICS AND DISSEMINATION:This project will not affect clinical practice and has been classified as clinical audit following research ethics review. The protocol will be disseminated through the international GlobalSurg network. TRIAL REGISTRATION NUMBER:NCT02662231.

SUBMITTER: GlobalSurg Collaborative

PROVIDER: S-EPMC5577891 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Determining the worldwide epidemiology of surgical site infections after gastrointestinal resection surgery: protocol for a multicentre, international, prospective cohort study (GlobalSurg 2).

BMJ open 20170721 7

<h4>Introduction</h4>Surgical site infection (SSI) is the most common complication following major gastrointestinal surgery, affecting between 25% and 40% of patients. The rate of SSI doubles from low-income to high-income settings, persisting after risk adjustment. The relative impact of antibiotic-resistant organisms and the effectiveness of antibiotic prophylaxis globally are unknown. This study aims to determine SSI rates following gastrointestinal surgery across worldwide hospital settings. ...[more]

PMID: 28733294

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Project description:BackgroundSurgical site infection (SSI) is one of the most common infections associated with health care, but its importance as a global health priority is not fully understood. We quantified the burden of SSI after gastrointestinal surgery in countries in all parts of the world.MethodsThis international, prospective, multicentre cohort study included consecutive patients undergoing elective or emergency gastrointestinal resection within 2-week time periods at any health-care facility in any country. Countries with participating centres were stratified into high-income, middle-income, and low-income groups according to the UN's Human Development Index (HDI). Data variables from the GlobalSurg 1 study and other studies that have been found to affect the likelihood of SSI were entered into risk adjustment models. The primary outcome measure was the 30-day SSI incidence (defined by US Centers for Disease Control and Prevention criteria for superficial and deep incisional SSI). Relationships with explanatory variables were examined using Bayesian multilevel logistic regression models. This trial is registered with ClinicalTrials.gov, number NCT02662231.FindingsBetween Jan 4, 2016, and July 31, 2016, 13 265 records were submitted for analysis. 12 539 patients from 343 hospitals in 66 countries were included. 7339 (58·5%) patient were from high-HDI countries (193 hospitals in 30 countries), 3918 (31·2%) patients were from middle-HDI countries (82 hospitals in 18 countries), and 1282 (10·2%) patients were from low-HDI countries (68 hospitals in 18 countries). In total, 1538 (12·3%) patients had SSI within 30 days of surgery. The incidence of SSI varied between countries with high (691 [9·4%] of 7339 patients), middle (549 [14·0%] of 3918 patients), and low (298 [23·2%] of 1282) HDI (p<0·001). The highest SSI incidence in each HDI group was after dirty surgery (102 [17·8%] of 574 patients in high-HDI countries; 74 [31·4%] of 236 patients in middle-HDI countries; 72 [39·8%] of 181 patients in low-HDI countries). Following risk factor adjustment, patients in low-HDI countries were at greatest risk of SSI (adjusted odds ratio 1·60, 95% credible interval 1·05-2·37; p=0·030). 132 (21·6%) of 610 patients with an SSI and a microbiology culture result had an infection that was resistant to the prophylactic antibiotic used. Resistant infections were detected in 49 (16·6%) of 295 patients in high-HDI countries, in 37 (19·8%) of 187 patients in middle-HDI countries, and in 46 (35·9%) of 128 patients in low-HDI countries (p<0·001).InterpretationCountries with a low HDI carry a disproportionately greater burden of SSI than countries with a middle or high HDI and might have higher rates of antibiotic resistance. In view of WHO recommendations on SSI prevention that highlight the absence of high-quality interventional research, urgent, pragmatic, randomised trials based in LMICs are needed to assess measures aiming to reduce this preventable complication.FundingDFID-MRC-Wellcome Trust Joint Global Health Trial Development Grant, National Institute of Health Research Global Health Research Unit Grant.

Project description:Introduction: The objective of the analysis was to determine the epidemiology of healthcare-associated infections (HAIs) in neurosurgical patients, paying special attention to two time points, 2003 and 2017, in order to evaluate the effectiveness of a surveillance program introduced in 2003 and efforts to reduce infection rates. Materials and methods: Continuous surveillance during 2003⁻2017 carried out using the HAI-Net methodology allowed us to detect 476 cases of HAIs among 10,332 patients staying in a 42-bed neurosurgery unit. The intervention in this before⁻after study (2003⁻2017) comprised standardized HAI surveillance with regular analysis and feedback. Results: The HAI incidence during the whole study was 4.6%. Surgical site infections (SSIs) accounted for 33% of all HAIs with an incidence rate of 1.5%. The remaining infections were pneumonia (1.1%) and bloodstream infections (0.9%). The highest SSI incidence concerned spinal fusion (FUSN, 2.2%), craniotomy (1.9%), and ventricular shunt (5.1%) while the associated total HAI incidence rates were 4.1%, 8.0%, and 18.6%, respectively. A significant reduction was found in HAI incidence between 2003 and 2017 in regard to the most common surgery types: laminectomy (4.5% vs. 0.8%); FUSN (11.8% vs. 0.8%); and craniotomy (10.1% vs. 0.4%). Significant changes were also achieved in selected elements of the unit's work: pre-hospitalization duration, hospital stay, and surgery length reductions. Simultaneously, the general condition of patients became significantly worse: there was an increase in patients' age and decreases in their general condition as expressed by ASA scores (The American Society of Anesthesiologists physical status classification system). Conclusions: HAI epidemiology changed substantially during the study period. Among the main types of HAI, SSIs were slightly predominant, but non-surgical HAIs accounted for almost two thirds of all infections; this indicates the need for surveillance of infection types other than SSIs in surgical patients. The implementation of active surveillance based on regular analysis and feedback led to a significant reduction in HAI incidence.

Project description:BACKGROUND:Surgical site infections (SSIs) are among the most common hospital acquired infections. While the incidence of SSI in certain indicator procedures is the subject of ongoing surveillance efforts in hospitals and health care systems around the world, SSI rates vary markedly within surgical categories and are poorly represented by routinely monitored indicator procedures (eg, mastectomy or hernia surgery). Therefore, relying on indicator procedures to estimate the burden of SSI is imprecise and introduces bias as hospitals may take special precautions to achieve lower SSI rates. The most common cause of SSI is Staphylococcus aureus (S. aureus), as recently confirmed by a Europe-wide point-prevalence study conducted by the European Centre for Disease Prevention and Control (ECDC). OBJECTIVE:The primary objective of this study is to determine the overall and procedure-specific incidence of S. aureus SSI in Europe. Secondary objectives are the overall and procedure-specific outcomes as well as the economic burden of S. aureus SSI in Europe. Explorative objectives are to characterize the composition of the surgical patient population and to estimate the number of patients at risk for S. aureus SSI. METHODS:A retrospective, multinational, multicenter cohort study (Staphylococcus aureus Surgical Site Infection Multinational Epidemiology in Europe [SALT] study) with a nested case-control part will be conducted. The study will include all surgical procedures at a participating center in order to prevent selection bias and strengthen the understanding of SSI risk by determining the incidence for all common surgical procedures. Data will be assessed in the cohort population, including 150,000 adult patients who underwent any surgical procedure in 2016, and the case-control population. We will match patients establishing S. aureus SSI 1:1 with controls from the same center. Data on demographics, surgery, and microbiology will be exported from electronic files. More detailed data will be captured from the case-control population. The SALT study will include 13 major or academic surgical centers in Europe, comprising 3 in France, 4 in Germany, 2 in Italy, 3 in Spain, and 1 in the United Kingdom. Sites were selected using a feasibility questionnaire. RESULTS:The SALT study is currently recruiting patients. The aim is to complete recruitment in February 2018 and to close the database in September 2018. The final results are expected by the end of 2018. CONCLUSIONS:Results of the SALT study will help to better understand the precise risk of certain procedures. They will also provide insight into the overall and procedure-specific incidence and outcome as well as the economic burden of S. aureus SSI in Europe. Findings of the study may help guide the design of clinical trials for S. aureus vaccines. TRIAL REGISTRATION:ClinicalTrials.gov NCT03353532; https://clinicaltrials.gov/ct2/show/NCT03353532 (Archived by WebCite at http://www.webcitation.org/6xAK3gVmO).

Dataset Information

Determining the worldwide epidemiology of surgical site infections after gastrointestinal resection surgery: protocol for a multicentre, international, prospective cohort study (GlobalSurg 2).

Publications

Determining the worldwide epidemiology of surgical site infections after gastrointestinal resection surgery: protocol for a multicentre, international, prospective cohort study (GlobalSurg 2).

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