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Routine use of expensive products during surgery of the abdomen (the area between chest and groin) does not reduce the risk of surgery infections. New research in low and middle income countries found infections were no more likely when cheaper alternatives were used.

Infection of the site of surgery is one of the most common complications of surgery worldwide. In 2016, the World Health Organization (WHO) made a series of recommendations about ways to reduce infections. These included an ointment to clean the skin (alcoholic chlorhexidine) and sutures (stitches) that were coated with an anti-bacterial compound (triclosan). These products are more expensive than commonly-used alternatives. There was little evidence about how well they work, especially in low or middle income countries.

The new trial, called FALCON, included 5,788 patients having abdominal surgery in low and middle income countries. Researchers found no benefit from alcoholic chlorhexidine skin preparation, compared with the cheaper alternative (povidone–iodine). Triclosan-coated stitches were similarly no better than uncoated stitches.

The researchers have passed their findings on to the WHO, and recommend that the guidance is revised. They say surgeons may choose not to use the more expensive products routinely.

What’s the issue?

More than 4 million people die within 30 days of surgery each year, more than from HIV, malaria and tuberculosis combined. People in low and middle income countries are 3 times more likely to die after surgery than those in wealthier countries. The NIHR’s Global Health Research Unit on Global Surgery was set up to address this challenge and funded this study.

The study, called FALCON, looked at infection of the surgical wound (where skin is cut). It is one of the most common complications of surgery, causes pain and distress, and slows people’s healing and recovery. Surgical site infection can also increase the risk of further complications.

The WHO stated that alcoholic chlorhexidine cleans the skin before surgery more effectively than standard iodine ointment. It also said that a coating of triclosan on stitches can reduce the growth of bacteria and fungi (compared to stitches with no coating). These measures are therefore believed reduce surgical infections.

However, the WHO recommendations are based on an analysis which included only one high-quality trial. This trial was carried out in the US and did not include surgery with a higher risk of infection, for example because the wound has been exposed to poo (faeces) from the gut (classified as contaminated or dirty).

Chlorhexidine and triclosan-coated sutures are more expensive than alternatives. The FALCON team wanted to know whether these products reduce surgical site infections in low and middle income countries, and in contaminated wounds. They wanted to see if the extra cost was justified.

What’s new?

The study was carried out in 54 hospitals in 7 countries: Benin, Ghana, India, Mexico, Nigeria, Rwanda and South Africa. It included people of all ages and those having emergency, as well as planned, surgery. Surgeons randomly assigned patients to receive:

  • alcoholic chlorhexidine or cheaper (povidone–iodine) skin preparation
  • triclosan-coated stitches or cheaper non-coated stitches.

Patients were grouped according to the degree of wound contamination present or expected. The study included 3,091 people whose surgery was expected to have a low risk of infection (clean or clean-contaminated); plus 2697 with contaminated or dirty wounds. All other procedures were followed as usual.

The main outcome was surgical site infection in the 30 days after surgery. The study found that neither chlorhexidine ointment nor triclosan-coated stitches made any difference to the results, at any level of contamination.

Overall, surgical site infection was common and occurred 1 in 5 (22%) people. As expected, more people (30%) with contaminated or dirty wounds - and fewer (15%) of those with clean or clean-contaminated wounds - had an infected surgical wound.

The researchers looked at a range of other outcomes and found, again, that the more expensive products (chlorhexidine ointment and triclosan-coated stitches) were no more beneficial than cheaper products. Within 30 days of surgery, there was no improvement in how long people stayed in hospital, whether they needed to be readmitted and to have further surgery, or whether they could return to normal activities.

The findings held true whether surgery was emergency or planned, and in all age groups, including children.

Why is this important?

FALCON is larger than the combined total of all other trials looking at contaminated and dirty surgery. It included people who are often under-represented in trials such as children, those who are having emergency surgery, have contaminated or dirty wounds, and are in rural hospitals in low income countries.

It found that routine use of more expensive products did not reduce surgical site infections. The study concluded that surgeons are justified in using lower-cost products as there is no clear benefit from the more expensive products. This is particularly important where resources are most limited.

Costs are covered by patients as well as by providers and must be used for maximum benefit. These findings are relevant in countries beyond those included in the study

The study also shows the importance of conducting large-scale, high quality trials in low income countries, where the problem of infected surgical wounds is greatest. This ensures that recommendations about care are relevant to those countries.

What’s next?

The research team is currently pooling results from many studies (in a meta-analysis) to summarise the evidence on the topic, including the new trial. The researchers will present the information to the WHO and to the UK’s National Institute for Health and Care Excellence (NICE). They hope that recommendations about routine use of expensive products will be revised.

You may be interested to read

This Alert is based on: NIHR Global Research Health Unit on Global Surgery. Reducing surgical site infections in low-income and middle-income countries (FALCON): a pragmatic, multicentre, stratified, randomised controlled trial. Lancet 2021;398:1687-1699

The website of the NIHR Global Health Research Unit on NIHR Global Health Research Unit on Global Surgery has information about ongoing trials addressing surgical safety worldwide

Case study: Improving global surgical outcomes through collaborative research - from the NIHR Global Health Research Unit.

Funding: This research was funded by the NIHR using UK Government aid to support global health research.

Conflicts of Interest: The study authors declare no conflicts of interest.

Disclaimer: NIHR Alerts are not a substitute for professional medical advice. They provide information about research which is funded or supported by the NIHR. Please note that views expressed in NIHR Alerts are those of the author(s) and reviewer(s) and not necessarily those of the NHS, the NIHR or the Department of Health and Social Care.


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Comments

Study author

Fundamentally, we could find no evidence to support routine use of either intervention. Our suggestion is that people don’t use them routinely, because there is no definite benefit. They might use them in selected cases.

It is about ensuring that spending is as efficient as possible, as justified as possible. Here we can justify using the lower cost options.

These findings will have an impact both in the global South and in the NHS, because they are relevant to patients everywhere. They will have an impact beyond the countries included, which is really interesting.

Aneel Bhangu, NIHR Clinical Scientist in Global Surgery, Global Health Research Unit on Global Surgery, Institute of Translational Medicine, Birmingham

Royal College of Surgeons 

FALCON is a major practice changing trial and the authors are to be congratulated. Current World Health Organization (WHO) guidelines recommend the use of alcoholic chlorhexidine for skin preparation and triclosan-coated sutures for fascial closure, in order to reduce the risk of surgical site infections (SSI), postoperatively. FALCON was a stratified, randomised controlled trial, conducted in seven low-income and middle-income countries, that aimed to establish if the postoperative SSI rate differed between patients receiving 2% alcoholic chlorhexidine or 10% aqueous povidone-iodine for skin preparation, or between patients undergoing fascial closure with a triclosan-coated or a non-coated suture. There was no significant difference in postoperative SSI rates between the groups. Neither triclosan-coating of sutures for fascial closure, nor alcoholic chlorhexidine, as opposed to povidone-iodine, for skin preparation, conferred a clinical benefit in the reduction of the SSI rate in patients with clean-contaminated or contaminated-dirty wounds. Further, triclosan-coated sutures and alcoholic chlorhexidine are not cost-efficient interventions, as they are significantly more expensive, and less accessible, than alternatives. This trial does not support the routine use of these recommended interventions over cheaper, more accessible alternatives, in resource-limited settings.

Natalie Simon and Peter Hutchinson, University of Cambridge & Royal College of Surgeons of England

Surgeon

Many guidelines before now are directed at high income countries where there are lots of resources. Many low and middle income countries don’t have these opportunities. It’s therefore difficult for them to ‘cut and paste’ and use guidelines from high income countries.

This study is the largest and most comprehensive in print to date, with the most rigorous methodology to avoid bias. Its clear result is that there is no difference. That implies that surgeons in low and middle income countries who cannot afford antibiotic-impregnated sutures – which are about 5 times more expensive than plain sutures – can confidently use those sutures without thinking they have done their patients any disservice. That is a huge relief for patients. Some end up in poverty because of healthcare costs, selling their lands, farm, losing their properties.

I’m a paediatric surgeon. I’m now more confident to talk to the parents of my patients and say we’re comfortable and confident with what we’re using in surgery. We can tell them on the strength of evidence, from over 6,000 patients across different geopolitical zones in low and middle income countries, we have found there is no difference.

Adesoji O Ademuyiwa, Professor of Surgery, University of Lagos, and Honorary Consultant Paediatric Surgeon, Lagos University Teaching Hospital, Nigeria.

Member of the Public

This paper will have most impact in the countries surveyed. Surgeons and other clinicians in these countries need to know about this research.

James Whittell, Public Contributor, Surrey 

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