Explore the vast range of titles available.

Surgical site infection (SSI) remains the most common complication of surgery around the world. WHO does not make recommendations for changing gloves and instruments before wound closure owing to a lack of evidence. This study aimed to test whether a routine change of gloves and instruments before wound closure reduced abdominal SSI. ChEETAh was a multicentre, cluster randomised trial in seven low-income and middle-income countries (Benin, Ghana, India, Mexico, Nigeria, Rwanda, South Africa). Any hospitals (clusters) doing abdominal surgery in participating countries were eligible. Clusters were randomly assigned to current practice (42) versus intervention (39; routine change of gloves and instruments before wound closure for the whole scrub team). Consecutive adults and children undergoing emergency or elective abdominal surgery (excluding caesarean section) for a clean–contaminated, contaminated, or dirty operation within each cluster were identified and included. It was not possible to mask the site investigators, nor the outcome assessors, but patients were masked to the treatment allocation. The primary outcome was SSI within 30 days after surgery (participant-level), assessed by US Centers for Disease Control and Prevention criteria and on the basis of the intention-to-treat principle. The trial has 90% power to detect a minimum reduction in the primary outcome from 16% to 12%, requiring 12 800 participants from at least 64 clusters. The trial was registered with ClinicalTrials.gov, NCT03700749. Between June 24, 2020 and March 31, 2022, 81 clusters were randomly assigned, which included a total of 13 301 consecutive patients (7157 to current practice and 6144 to intervention group). Overall, 11 825 (88·9%) of 13 301 patients were adults, 6125 (46·0%) of 13 301 underwent elective surgery, and 8086 (60·8%) of 13 301 underwent surgery that was clean–contaminated or 5215 (39·2%) of 13 301 underwent surgery that was contaminated–dirty. Glove and instrument change took place in 58 (0·8%) of 7157 patients in the current practice group and 6044 (98·3%) of 6144 patients in the intervention group. The SSI rate was 1280 (18·9%) of 6768 in the current practice group versus 931 (16·0%) of 5789 in the intervention group (adjusted risk ratio: 0·87, 95% CI 0·79–0·95; p=0·0032). There was no evidence to suggest heterogeneity of effect across any of the prespecified subgroup analyses. We did not anticipate or collect any specific data on serious adverse events. This trial showed a robust benefit to routinely changing gloves and instruments before abdominal wound closure. We suggest that it should be widely implemented into surgical practice around the world. National Institute for Health Research (NIHR) Clinician Scientist Award, NIHR Global Health Research Unit Grant, Mölnlycke Healthcare.

First referral hospitals, often known as district hospitals, are neglected in the discourse on universal health coverage in low-income and middle-income countries (LMICs). However, these hospitals are important for delivering safe surgery for 313 million people. This study aims to understand the structures, processes and outcomes of patients undergoing surgery in these centres in LMICs. This is a preplanned secondary analysis using data from two high-quality randomised controlled trials undergoing major abdominal surgery across six LMICs. Type of hospital was the main explanatory variable, defined according to the WHO taxonomy as first referral (ie, district or rural) and referral (ie, secondary or tertiary). Of the included 15 657 patients across 80 hospitals from 6 countries, 3562 patients underwent surgery in first referral and 12 149 patients underwent surgery in referral centres. First referral centres have lower full-time surgeons (median: 1 vs 20, p<0.001) and medically trained anaesthetists (28.6% vs 87.1%, p<0.001) compared with referral centres. Patients undergoing surgery in first referral centres were more likely to have lower rates of American Society of Anaesthesiologist (ASA) grades III–V (8.1% vs 22.7%, p<0.001), but higher rates of emergency procedures (65.1% vs 56.6%, p<0.001). In first referral centres, there was a significantly higher use of WHO surgical safety checklist (99.4% vs 93.3%, p<0.001) compared with referral centres. In adjusted analyses, there were no differences in 30-day mortality (OR 1.09, 95% CI 0.73 to 1.62) and surgical site infection (OR 1.30, 95% CI 0.89 to 1.90) between first referral and referral centres. Postoperative mortality and surgical site infection remain similar between first referral and referral centres in LMICs. There may be a clear need to upscale surgical volume safely in first referral centres to meet global surgical needs. High-quality research is needed to drive safe expansion of surgical workforce and strengthen referral pathways within these surgical health systems in LMICs.

Background Cluster randomised controlled trials (cRCT) present challenges regarding risks of bias and chance imbalances by arm. This paper reports strategies to minimise and monitor biases and imbalances in the ChEETAh cRCT. Methods ChEETAh was an international cRCT (hospitals as clusters) evaluating whether changing sterile gloves and instruments prior to abdominal wound closure reduces surgical site infection at 30 days postoperative. ChEETAh planned to recruit 12,800 consecutive patients from 64 hospitals in seven low-middle income countries. Eight strategies to minimise and monitor bias were pre-specified: (1) minimum of 4 hospitals per country; (2) pre-randomisation identification of units of exposure (operating theatres, lists, teams or sessions) within clusters; (3) minimisation of randomisation by country and hospital type; (4) site training delivered after randomisation; (5) dedicated ‘warm-up week’ to train teams; (6) trial specific sticker and patient register to monitor consecutive patient identification; (7) monitoring characteristics of patients and units of exposure; and (8) low-burden outcome-assessment. Results This analysis includes 10,686 patients from 70 clusters. The results aligned to the eight strategies were (1) 6 out of 7 countries included ≥ 4 hospitals; (2) 87.1% (61/70) of hospitals maintained their planned operating theatres (82% [27/33] and 92% [34/37] in the intervention and control arms); (3) minimisation maintained balance of key factors in both arms; (4) post-randomisation training was conducted for all hospitals; (5) the ‘warm-up week’ was conducted at all sites, and feedback used to refine processes; (6) the sticker and trial register were maintained, with an overall inclusion of 98.1% (10,686/10,894) of eligible patients; (7) monitoring allowed swift identification of problems in patient inclusion and key patient characteristics were reported: malignancy (20.3% intervention vs 12.6% control), midline incisions (68.4% vs 58.9%) and elective surgery (52.4% vs 42.6%); and (8) 0.4% (41/9187) of patients refused consent for outcome assessment. Conclusion cRCTs in surgery have several potential sources of bias that include varying units of exposure and the need for consecutive inclusion of all eligible patients across complex settings. We report a system that monitored and minimised the risks of bias and imbalances by arm, with important lessons for future cRCTs within hospitals.