Urgent changes needed to global guidelines designed to stop surgical infection

Peer-Reviewed Publication

UNIVERSITY OF BIRMINGHAM

Wound infections are the most common problem after surgery, particularly in developing countries, but promised innovations to tackle the issue do not work and global guidance needs changing, a new study reveals.

Both World Health Organisation (WHO) and the UK’s National Institute of Health Research guidelines recommend that surgeons use alcoholic chlorhexidine skin preparation and triclosan coated sutures to prevent Surgical Site Infection (SSI).

However, the world’s largest wound infection trial could not demonstrate superiority of these interventions over lower cost alternatives.

Carried out in Benin, Ghana, India, Mexico, Nigeria, Rwanda and South Africa, the FALCON trial was funded by the UK’s National Institute for Health Research (NIHR).

Publishing their findings today in The Lancet, researchers participating in this study are calling for guidelines recommending these measures, either specifically to Low- and Middle-income Countries (LMIC) or at a general global level, to be revised.

Co-author Mr. Aneel Bhangu, from the University of Birmingham, commented: “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.”

Patients who develop SSI experience pain, disability, poor healing with risk of wound breakdown, prolonged recovery times and psychological challenges.

Those patients in LMICs are disproportionately affected by higher rates of SSI compared to those in high-income countries - increasing the risk of catastrophic expenditure, impoverishment, and wider negative community impact.

The NIHR Global Research Health Unit on Global Surgery trial covered 5,788 patients from 54 hospitals in seven countries - a broad and representative range including adults and children undergoing contaminated/dirty surgery, emergency surgery and caesarian section.

Co-author Professor Adesoji Ademuyiwa, from the University of Lagos, commented: “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.”

For further information, interviews or to request an embargoed copy of the research paper please contact Tony Moran, International Communications Manager, University of Birmingham on +44 (0)782 783 2312 or t.moran@bham.ac.uk. Out-of-hours, please call +44 (0) 7789 921 165.

Notes for editors

• The University of Birmingham is ranked amongst the world’s top 100 institutions. Its work brings people from across the world to Birmingham, including researchers, teachers and more than 6,500 international students from over 150 countries.
• ‘Reducing surgical site infections in low and middle income countries: a pragmatic, multicentre, stratified, randomised controlled trial (FALCON)’ - Adesoji O Ademuyiwa and Aneel Bhangu is published in The Lancet.
• Please feel free to include this post-embargo link in online articles: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01548-8/fulltext

The mission of the National Institute for Health Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:

• Funding high quality, timely research that benefits the NHS, public health and social care;
• Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
• Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
• Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
• Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
• Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.

NIHR is funded by the Department of Health and Social Care. Its work in low and middle income countries is principally funded through UK Aid from the UK government.

---

JOURNAL

The Lancet

METHOD OF RESEARCH

Data/statistical analysis

SUBJECT OF RESEARCH

People

ARTICLE TITLE

Reducing surgical site infections in low and middle income countries: a pragmatic, multicentre, stratified, randomised controlled trial (FALCON)

ARTICLE PUBLICATION DATE

25-Oct-2021