SummaryBackgroundSurgical 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,...

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Background: Hypersensitivity reactions (HSRs) to components of cardiac implantable electronic devices (CIEDs) are rare but difficult to differentiate from device infection. Data on best management strategies of HSRs to CIEDs are lacking. The aims of this systematic review are to summarise the available literature on the aetiology, diagnosis and management of HSR in CIED patients and to provide guidance on best management strategies for these patients. Methods and Results: A systematic search for publications on HSR to CIED in PubMed from January 1970 to November 2022 was conducted, resulting in 43 publications reporting on 57 individual cases. The quality of data was low. The mean age was 57 ± 21 years, and 48% of patients were women. The mean time from implant to diagnosis was 29 ± 59 months. Multiple allergens were identified in 11 patients (19%). In 14 cases (25%) no allergen was identified. Blood tests were mostly normal (55%), but eosinophilia (23%), raised inflammatory markers (18%) and raised immunoglobulin E (5%) were also encountered. Symptoms included local reactions, systemic reactions or both in 77%, 21% and 7% of patients, respectively. Explantation of CIED and reimplantation of another CIED coated with a non-allergenic material was usually successful. Use of topical or systemic steroids was associated with high failure rates. Conclusion: Based on the limited data available, the treatment of choice for HSRs to CIEDs is full CIED removal, reassessment of CIED indication and reimplantation of devices coated in non-allergenic materials. Steroids (topical/systemic) have limited efficiency and should not be used. There is an urgent need for further research in this field.

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