The Clinical Trials Network Australia and New Zealand (CTANZ) is one network consisting of 16 different Clinical Trial Networks (CTNs) within the Royal Australasian College of Surgeons (RACS). Of those networks, there are 10 different surgical specialties or subspecialties. CTANZ’s unique structure, and its close working relationship with its sister organisation in the UK, the Royal College of Surgeons Clinical Trials Network UK (CTN-UK), allows the group to conduct large investigator-led clinical trials across Australia and internationally.
SUNRRISE
One product of this collaboration is the Single Use Negative pRessure dressing for Reduction In Surgical site infection following Emergency laparotomy (SUNRRISE) trial, a collaboration between CTANZ, CTN-UK and the University of Birmingham in England.
The SUNRRISE trial aims to take patients having emergency abdominal surgery and randomise them to a standard wound dressing post-surgery or a single-use negative pressure dressing. The negative pressure dressing is a device that puts suction on the wound and is claimed to reduce wound infection-post surgery. However, Professor David Watson, Clinical Director of CTANZ suggests that the evidence for effectiveness is anecdotal and the devices need to be investigated further to build higher-quality evidence to determine whether the devices work or not.
“The devices aren’t cheap—they’re about $400 a pop, so it’s really worthwhile to look at whether they work. And if they do, you could make a case for using them routinely. If they don’t work, you shouldn’t use them,” said Prof Watson.
The study was originally developed in 2018 in Birmingham, UK. The UK group proposed recruiting 630 patients to achieve a significant outcome. CTANZ proposed an additional cohort in Australia, and were subsequently funded for an additional 210 patients, to increase the evidential power to 90%.
Prof Watson considers himself lucky that the trial began before the COVID-19 outbreak. Despite the virus, SUNRRISE is recruiting at four times the expected rate, partially due to the embedded nature of the trial. Nearly 50% of the recruitment target has been achieved in just over three months.
“Essentially we’re taking patients who are having emergency surgery on their abdomen and they just have to consent to being randomised one of these two dressings. They have to agree to allow us to collect data and they have to agree to a telehealth or face-to-face interview at one month. We built telehealth into it because of geographic reasons in Australia, but the British groups didn’t. And that turned out to be a stroke of luck, because we’re now doing all of the follow-ups remotely.”
Originally, the group in Birmingham was recruiting 75% of participants for the study. Because the UK has now been significantly impacted by the COVID-19 virus, all clinical research has been halted. In the meantime, CTANZ has continued recruiting, with potential to go beyond their initially expected cohort. CTANZ's ongoing contribution has ensured the success of this trial, and that the recruitment target will be met.
“We decided that as long as we’re not adding clinical contact above what would be considered standard clinical care, there is no reason to stop the trial in Australia. We’re performing routine practice and all the follow-up can be done remotely, so there’s no reason that this trial can’t continue.
“We also set aside some resources for a proper health economics assessment. The dressing is around $400 but a standard hospital bed costs around $800-$1000 dollars a day. If you can reduce the length of stay by preventing wound infections then it makes sense, but you need to prove that,” said Prof Watson.
Responding to COVID-19 with COVIDsurg
While tighter government restrictions can restrict trials, as demonstrated by the halting of trials in the UK, CTANZ has responded by using its network and experience to facilitate COVID-19 related trials.
Teaming up with Birmingham and other collaborators once more, CTANZ has been contributing to a large international data collection around surgical outcomes for patients who have been infected with the COVID virus.
COVIDsurg is working across Europe, North America, Asia, Africa, Australia and New Zealand; with up to half of the larger public hospitals in Australia and New Zealand now actively involved. The study aims to gather data on at least 2,000-3,000 patients who have the coronavirus at the time of surgery. That person may be admitted to hospital and is known to have the virus and requires surgery, or it may be someone who has been diagnosed with a COVID-19 infection in the week after surgery.
“Early outcomes from this study have now been accepted for publication in The Lancet, and suggest that if you have surgery of any sort, you’re looking at a death rate of at least 20% if you’re diagnosed with COVID-19 after surgery,” said Prof Watson, “Basically we’re trying to find out what the issues are, and should we be changing practice?”
A similar study out of Wuhan suggests that due to the impact COVID-19 has on the respiratory system, if a patient has major surgery that requires anaesthetic (which impacts lung function), the risk of dying in surgery increases to almost 40%.
“The interesting thing is that COVIDsurg highlights the problems we have with research ethics and governance, and different approaches in different regions and hospitals, and accentuates the need for a more consistent national process,” Prof Watson said.
The study took only two weeks to start in many hospitals. Although the data-collection hasn’t been running for long, CTANZ is already facilitating a secondary study off the back of COVIDsurg to review the ethics and governance processes with the idea of collating and reporting results as a way of encouraging some consistency post-COVID-19.
The need for streamlined national ethics and governance
“In some states COVIDsurg has been put forward as a low-risk audit and no formal ethics have been required, but other states have required a legal process to formalise participation. By the time that gets through the process, the opportunity will be lost. So this really demonstrates the need for a streamlined national system,” said Prof Watson.
The results of the ethics and governance review are now being collated, and will be submitted for publication in coming weeks.