Negative Pressure Dressings to Prevent Surgical Site Infection After Emergency Laparotomy: The SUNRRISE Randomized Clinical Trial

Importance: Patients undergoing unplanned abdominal surgery are at increased risk of surgical site infection (SSI). It is not known if incisional negative pressure wound therapy (iNPWT) can reduce SSI rates in this setting.

Objective: To evaluate the effectiveness of iNPWT in reducing the rate of SSI in adults undergoing emergency laparotomy with primary skin closure.

Design, Setting, and Participants: SUNRRISE was an assessor-masked, pragmatic, phase 3, individual participant randomized controlled trial. Adult patients undergoing emergency laparotomy in 22 hospitals in the UK and 12 in Australia between 18 December 2018 and 25 May 2021 were recruited. Patients were followed-up for 30 days post-operation; database closure was 25 August 2021.

Interventions: Participants were randomized 1:1 to receive iNPWT (n = 411), which involved a specialized dressing used to create negative pressure over the closed wound versus the surgeons’ choice of wound dressing (n = 410). Randomization and dressing application occurred in the theatre at the end of surgery.

Main outcomes and measures: The primary outcome measure was SSI up to 30-days post-surgery, evaluated by an assessor masked to the randomized allocation and using the criteria from the US Centers for Disease Control and Prevention. There were 7 secondary outcomes, including length of hospital stay, postoperative complications up to 30 days, hospital re-admission for wound-related complications within 30 days, wound pain, and quality of life.

Results: 840 patients were randomized (536 from the UK, 304 from Australia). Overall, 52% were female; the mean age was 63.8 years (range 18.8 to 95.3). After post-randomization exclusions (N=52), 394 participants per group were included in the primary analysis. The number of participants who had an SSI in the iNPWT group was 112 of 394 (28.4%) compared with 108 of 394 (27.4%) in the surgeon’s preference group (relative risk 1.03, 95%CI 0.83 to 1.28, p=0.78). This finding was consistent across the pre-planned subgroup analyses including degree of contamination, presence of a stoma, participant body mass index, and skin preparation used and across all pre-planned sensitivity analyses. Of 7 secondary outcomes, 6 showed no significant difference including hospital readmission, quality of life, and hospital stay (median [IQR], 8 days [6-14 days] in the iNPWT and 9 days [6-14.5 days] for the surgeon’s preference group [ratio of geometric means=0.96, 95%CI 0.88-1.06, p=0.21]).

Conclusions and relevance: Routine application of iNPWT to the closed surgical wound after emergency laparotomy did not prevent SSI.

Funding: SUNRRISE was investigator-initiated and led. It was funded by the NIHR Research for Patient Benefit Programme (PB-PG-0416-20045) in the UK and the Medical Research Future Fund (MRFF) International Clinical Trials Collaboration Program (2019/MRF1179938) in Australia. PICO7 dressings were provided free of charge by Smith and Nephew®. The funders had no role in the study design, data collection, data analysis, data interpretation, writing of the report, or the decision to publish.

Trial Registration: The study was registered at ISCTRN (17599457) and ACTRN (12619000496112).