Prevention of surgical site infection in low-resource settings
WHO defines universal health coverage (UHC) as “access to needed essential health services, without financial hardship”.
UHC requires about US$100 per head for an essential package of 218 interventions, and approximately $50 per head for a basic package of 108 of the highest priority interventions.
Yet, estimates in 2016 suggested that only nine of the 49 low-income and middle-income countries (LMICs) could afford the essential package, and that 16 countries could afford the 108 highest priority interventions of the basic package.
At an average government spend on health in low-income countries of only $9 per head in 2018 (1•2% of Gross National Product), literally every cent counts.
Surgical care is an indivisible component of UHC, yet the outcomes in low-income countries are poor.
Provision of quality surgical care in these countries is difficult because resources and finances are limited. International guidelines that are blind to these barriers can unwittingly compromise quality care elsewhere when scarce financial resources are wasted to comply with guidelines that have a poor evidence base. Availability of a stable surgical supply chain is a challenge for low-income countries, especially because production is often international and procurement is expensive. The resultant costs of surgical supplies are commonly transferred to the patients, often leading to catastrophic out-of-pocket expenditure.
Those who cannot afford these costs often do not receive surgical care. To realise the aspiration of UHC, affordable, sustainable solutions to the surgical needs of patients are needed.
Reported in The Lancet, the FALCON trial is an important surgical trial for advancing UHC in low-income settings. Surgical site infections (SSI) predominate perioperative complication with a higher burden and more antibiotic resistance in low-income countries.
The need for appropriate global guidelines for prevention of SSI is therefore important.
However, some recommendations are based on little evidence, with a negative financial effect in low-income countries. The FALCON trial provides the evidence necessary to inform the appropriateness of the WHO recommendation of 2% alcoholic chlorhexidine skin preparation and triclosan-coated sutures to prevent SSI in abdominal surgery in LMICs. Before this study, the evidence was generally weak, with little data from LMICs to support such a recommendation.
The FALCON trial found that neither 2% alcoholic chlorhexidine skin preparation nor triclosan-coated sutures provided benefit when compared with povidone–iodine skin preparation and non-coated sutures. The implications of these findings are that cheaper skin preparations and sutures can be safely used in low-resource environments with equivalent efficacy to prevent SSI, freeing up funds to improve the quality of care elsewhere.
The FALCON trial provides robust data for the prevention of SSI in LMICs. The trial included 5788 participants (61% were female), from 54 hospitals in seven LMICs, and included children (14%) and those needing emergency surgery (67%). The trial is powered at 90% for both clean-contaminated and contaminated or dirty surgery, which is important because of potentially differing SSIs associated with exposure and non-exposure to bowel contents. There are numerous appropriate sensitivity analyses that are all consistent with the primary outcome of the trial. It is therefore likely that the findings are generalisable to patients from LMICs having abdominal surgery. There are some trial limitations, including unmasked theatre staff, and the introduction of telephonic follow-ups during the COVID-19 pandemic. However, we believe that these limitations have not significantly compromised the trial findings to detract from the robust trial signal.
Similar to FALCON, evidence is needed to challenge other controversial practice guidelines in low-income countries, such as the WHO recommendation for the use of liberal inspired oxygen concentrations of 80% during surgery to prevent SSI.
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The retraction of several trials has raised further concerns regarding the evidence base.
The COVID-19 pandemic has highlighted the importance of oxygen as a scarce health-care resource, emphasising the need to establish the evidence for the recommendation for liberal inspired oxygen to prevent SSI. This issue is being addressed in another large pragmatic trial (PErioperative respiratory care and outcomes for patieNts Undergoing hIgh risk abdomiNal surgery [PENGUIN], NCT04256798) also led by the NIHR Global Health Research Unit on Global Surgery.
Source : Lancet