SP7.8 The SUNRRISE Trial – Single Use Negative pRessure dressing for Reduction in Surgical site infection following Emergency laparotomy

Abstract

Purpose/Background: Surgical Site Infections (SSI) are common after abdominal surgery, and more so after emergency laparotomy. Many aids and devices have been proposed to reduce the incidence and consequences, but few have been robustly tested in randomised trials. Despite Single Use Negative Pressure Dressings (SUNPDs) being expensive and having mixed evidence about their effectiveness, they are being increasingly used in clinical practice and are recommended in the WHO SSI Prevention guidelines. SUNRRISE is a multi-national, multi-centre, trainee devised, led and delivered randomised controlled trial, funded by the NIHR (UK) and MRFF (Australia). It investigates whether a SUNPD reduces the risk of wound infection within 30 days of emergency laparotomy patients. We present the results of this trial. Methods/Interventions: 840 patients were 1:1 randomised between SUNPD (PICO7 ©, Smith and Nephew) and surgeon's choice at 12 centres in Australia (304 patients) and 22 centres (536 patients) in England and Scotland between 2019 and 2021. Patients were eligible if they underwent an emergency laparotomy with an incision of at least 5cm that was primarily closed at the end of the operation. SSI was assessed at day 5-10 (or discharge if earlier), via a patient diary while the patient was at home and at day 30-44 by a blinded, trained wound assessor. Results/Outcomes: Patient recruitment was completed in May 2021. Data is being cleaned and analysed and results will be ready before the end of the year. Through collaboration between the UK and Australia the trial continued to recruit despite the global pandemic. SUNRRISE was the first trainee trial to collaborate across continents and the first to be funded and complete in Australia. Conclusion/Discussion: This trial will demonstrate clinical efficacy or not of SUNPD as an adjunct to reduce SSI after emergency laparotomy. It will demonstrate the cost utility of this if it is shown to be clinically effective. SUNRRISE has also demonstrated the resilience and efficacy of multi-national, multi-centre trainee delivered RCTs. SUNRRISE completed only modestly behind schedule in 2021, despite the disruption to non-COVID research in 2020/21, as it was able to increase recruitment in Australia to offset the reduction in the UK.