Abstract

Abstract Background Surgical Site Infections (SSI) are common after abdominal surgery, and more so after emergency laparotomy. Despite Single Use Negative Pressure Dressings (SUNPDs) having mixed evidence regarding effectiveness, they are recommended in the WHO SSI Prevention guidelines. SUNRRISE is an international, 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 SSI within 30 days of emergency laparotomy. Method Patients were randomised between SUNPD (PICO7©, Smith and Nephew) and surgeon's preference of dressing. 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, via a patient diary while the patient was at home and at day 30–44 by a blinded, trained wound assessor. Results 840 patients were randomised from 34 centres across the UK and Australia. Intention to treat analysis showed no difference in SSI between the two groups (SUNPD-28%, Control-27%, p=0.75). There was also no difference in all secondary outcomes- length of stay (9 vs 11, p=0.14), hospital readmission for wound related complications (3% vs 3%, p-0.96, rates of wound related complications (19% vs 18%, p-0.79), pain (1.8 vs 1.8, p-0.61) and quality of life (SF-12 & EQ5D-5L). Conclusion SUNRRISE is a multicentre, assessor blinded, phase III RCT that provides robust evidence that single-use negative pressure dressings are not effective in reducing surgical site infections in patients undergoing an emergency laparotomy.

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