Trial Background & Rational
Surgical site infection (SSI) represents a major burden for patients, doctors, and health systems across all settings. SSI is the commonest postoperative complication worldwide and the commonest healthcare-associated infection in low and middle income countries (LMICs). SSIs cause pain, discomfort, disability, and increase the time taken to return to work. SSIs increase health costs and this can have a major impact on patients, communities, and providers in LMICs where personal income is low and patients may be required to pay for their own treatment. SSI has also been associated with one-third of postoperative deaths and accounts for 8% of all deaths caused by a nosocomial infection.
The GlobalSurg-2 cohort study captured data on 12539 patients undergoing abdominal surgery across 343 hospitals in 66 countries, with a primary outcome measure of SSI. The overall SSI rate was 12.3% (1538/12539), which more than doubled across high, middle, and low human development index (HDI) countries (9.4%, 14.0%, 23.2%, respectively, p<0.001). The overall SSI rate in LMICs was 16.3% (847/5200). After risk adjustment for patient, disease, operative, and hospital factors, patients in low-income countries remained at greater risk of SSI than those in high-income countries (adjusted OR 1.60, 95% confidence interval 1.05-2.37, p=0.030). The overall SSI rates in children and adults were similar (12.1% vs. 12.3%).
Improving surgical outcomes is a global health priority, highlighted by the Lancet Commission on Global Surgery. Recent World Health Organisation (WHO) guidelines made 29 recommendations for intraoperative and postoperative measures to prevent SSI, including global perspectives relevant to LMICs. Despite inclusion of strongly graded recommendations, there was little high quality evidence in support of most interventions. In addition, none of the evidence used was derived from resource limited settings, leading to uncertainty about implementation of measures in these settings. A randomised trial with the potential to evaluate multiple interventions would establish a high quality evidence base that will inform guidance, and influence revisions to the WHO Surgical Safety Checklist. The specific interventions to be tested in the trial were selected by a Delphi process from a longlist of potential interventions based on the WHO guidelines.