Urgent changes are needed to global guidelines for preventing wound infections following surgery, researchers say today after completing a major study.
The World Health Organization (WHO) and the UK’s National Institute of Health Research guidelines recommend alcoholic chlorhexidine skin preparation and triclosan-coated sutures to prevent surgical site infection (SSI). But the world’s largest wound infection trial has been unable to demonstrate their superiority over lower-cost alternatives, researchers say.
The FALCON trial, led by the University of Birmingham, UK, is the first global surgical trial testing measures to reduce SSI following abdominal surgery in low and middle-income countries.
Launched in December 2018, it was carried out in Benin, Ghana, India, Mexico, Nigeria, Rwanda and South Africa, and the researchers found that the SSI rate was 22%.
Publishing their findings in The Lancet, they are now calling for guidelines to be revised either specifically to low- and middle-income countries (LMIC) or at a general global level.
Co-author Mr Aneel Bhangu, senior lecturer in surgery at the University of Birmingham, said: “Surgical site infection is the world’s most common postoperative complication, a major burden for both patients and health systems. We have delivered the biggest trial of its kind, where we could not demonstrate the superiority of these interventions over cheaper alternatives.
“Our findings are hugely important for a wide range of care providers in LMICs, as following existing WHO and NICE guidelines, which have significant cost implications for organisations which have limited resources.”
Co-author Professor Adesoji Ademuyiwa, of the University of Lagos, added: “The overall SSI rate was very high at 22% – a preventable complication that is causing unnecessary suffering and burden to patients and systems.
“It is clear that small randomised trials should now be avoided and should be replaced with larger trials that can provide more robust evidence on the incidence of SSI, ultimately leading to more effective measures to help tack this global healthcare challenge.”
Patients who develop SSI experience pain, disability, poor healing with risk of wound breakdown, prolonged recovery times and psychological challenges and patients in LMICs are disproportionately affected by higher rates.
The NIHR Global Research Health Unit on Global Surgery trial covered 5,788 patients from 54 hospitals in seven countries.
Ademuyiwa AO, Bhangu A et al. Reducing surgical site infections in low and middle income countries: a pragmatic, multicentre, stratified, randomised controlled trial (FALCON). Lancet 26 October 2021.
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