Wound infections are the most common postoperative complication, particularly in developing and low-income countries. Surgeons are recommended by WHO and the UK’s National Institute of Health Research guidelines to use alcoholic chlorhexidine skin preparation and triclosan coated sutures to prevent Surgical Site Infection (SSI).
However, findings from the FALCON trial, carried out in Benin, Ghana, India, Mexico, Nigeria, Rwanda, and South Africa, did not demonstrate superiority of these interventions over lower-cost alternatives.
Researchers who participated in the trial are advocating for the revision of global guidelines. Aneel Bhangu, co-author from the University of Birmingham, commented that SSI is 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,” he said.
Patients who develop SSI experience pain, disability, poor healing with risk of wound breakdown, prolonged recovery times, and psychological challenges. Co-author Professor Adesoji Ademuyiwa, from the University of Lagos, commented: “The overall SSI rate was very high at 22 per cent, 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.”
In an interview, Aneel further explained how these findings are immensely vital for a wide range of care providers in LMICs. “Following existing WHO and NICE guidelines, have significant cost implications for organisations which have limited resources.”
Can you tell us more about the genesis of the study, and why was it crucial to be carried out?
The interventions we tested within the study are included in clinical guidelines from the World Health Organisation. Before technologies, devices and drugs are placed in clinical practice, they need robust testing within a trial. Over 24 months, this trial was conducted and evidence toward the benefits and the risks were outlined. Cost is an important factor, in some parts of the world, especially in low- and middle-income countries, patients often pay for everything that is used during treatment. I believe the patient should only be paying if the treatment will work and there is proof of benefit.
We need to be researching and innovating more for the future. One of the risks of COVID moving forward is that we only provide basic health care, without the layers of innovation and research which we need. For example, keyhole surgery is an innovation that has proven benefits, and unless we continue to innovate, devices and techniques will not progress.
Continuing high-quality research is key in the present and post COVID era as it will guide improvements in treatment areas for our patients over the next decade.
How will findings from the study help steer future solutions in the right direction?
We are already conducting our next set of trials on this topic; the CHEETAH trial has recruited 9000 out of 12,800 patients. Changing instruments such as gloves before stitching up the wound will help determine if there is a decrease in infection rates. Therefore, we are testing more complicated behavioural and team-based approaches. By evaluating more complex areas, we will be able to prove or disprove benefits.
Can you tell us about the consequences of SSI?
Wound infection is the most common complication following an operation and they range from very minor to major complications. Wound breakdowns prolong for months, and this may affect a member of the household who is the breadwinner, which in turn can cause financial strain for the family and by large the community through living costs. Catastrophic expenditure is when a household spends 10 or 20 per cent of their annual income on their health care. Wound infections are a source of catastrophic expenditure, and once the family is plunged in, it can take years to recover.
Catastrophic expenditure can be worsened by a patient paying for treatments of no benefit to them. The most effective way to understand successful treatments is through evidence accumulated from a series of randomised trials and surgery. There are two aspects to this, the first is what is the cost of the wound infection? The cost of living varies in different societies.
The very first study we will produce is on what is the cost of wound infection in these countries. This is crucial, because if we can make the argument that reducing one wound infection will save the hospital $8,000 a year and save the patient $3,000 a year, then it becomes far easier to get policymakers and governments to make positive recommendations for this specific trial when we'll do a health economic analysis.
However, if the trial did not show a benefit then there is no cost-benefit. Nevertheless, it is still vital that we prove that some of these measures are either more cost-effective or expensive as we need to link the research to policymakers. Currently, there is a gap between the research paper and the policymaker, and we are working very hard to close that gap.
The study also touched upon a formal health economic analysis in a future paper, which will describe the global costs and potential savings based on FALCON results – can you elaborate on this?
Moving forward in COVID, we need to ensure that our systems are strengthened, research and testing of innovations should be of high quality along, with observations made smaller and more controllable. Keyhole techniques reduce costs, with reduced wound infections and hernias. However, surgery is best when it's put into a pathway for the patient. Presently, it's seen as via the end of that past pathway, as an expensive luxury or as a damage control procedure. What we want is to see surgery shifted right to the start of that pathway. For example, if you have bad appendicitis or cancer that ruptures in the abdomen, you will require major surgery, this can be avoided if a patient is diagnosed earlier and undergoes a less complex surgery with lower costs. Recovery is easier; therefore, surgery should be isolated but should be seen as an integrated pathway that can support whole communities.
The impact on patients and communities is significant, as surgery is expensive for hospitals and patients. Research is key in making surgery as effective and affordable as possible, some countries around the world, especially in low-income settings have low rates of surgery. Boosting the rate of surgery is important as it can limit the impact of diseases such as cancer. This needs to be done with safety and cost in mind to ensure that families live without the consequences of lifelong costs or infections.