Impact of wound edge protection devices on surgical site infection after laparotomy: multicentre randomised controlled trial (ROSSINI Trial)

Thomas D Pinkney, Melanie Calvert, David C Bartlett, Adrian Gheorghe, Val Redman, George Dowswell, William Hawkins, Tony Mak, Haney Youssef, Caroline Richardson, Steven Hornby, Laura Magill, Richard Haslop, Sue Wilson, Dion Morton, West Midlands Research Collaborative, ROSSINI Trial Investigators

Abstract

Objective: To determine the clinical effectiveness of wound edge protection devices in reducing surgical site infection after abdominal surgery.

Design: Multicentre observer blinded randomised controlled trial.

Participants: Patients undergoing laparotomy at 21 UK hospitals.

Interventions: Standard care or the use of a wound edge protection device during surgery.

Main outcome measures: Surgical site infection within 30 days of surgery, assessed by blinded clinicians at seven and 30 days and by patient's self report for the intervening period. Secondary outcomes included quality of life, duration of stay in hospital, and the effect of characteristics of the patient and operation on the efficacy of the device.

Results: 760 patients were enrolled with 382 patients assigned to the device group and 378 to the control group. Six patients in the device group and five in the control group did not undergo laparotomy. Fourteen patients, seven in each group, were lost to follow-up. A total of 184 patients experienced surgical site infection within 30 days of surgery, 91/369 (24.7%) in the device group and 93/366 (25.4%) in the control group (odds ratio 0.97, 95% confidence interval 0.69 to 1.36; P=0.85). This lack of benefit was consistent across wound assessments performed by clinicians and those reported by patients and across all secondary outcomes. In the secondary analyses no subgroup could be identified in which there was evidence of clinical benefit associated with use of the device.

Conclusions: Wound edge protection devices do not reduce the rate of surgical site infection in patients undergoing laparotomy, and therefore their routine use for this role cannot be recommended.

Trial registration: Current Controlled Trials ISRCTN 40402832.

Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf (available on request from the corresponding author) and declare: no support from any organisation for the submitted work; no financial relationships with any organisations that might have an interest in the submitted work in the previous three years; no other relationships or activities that could appear to have influenced the submitted work.

Figures

https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4793420/bin/pint010255.f1_default.jpg
Fig 1 Wound edge protection device being used during surgery via midline laparotomy incision
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4793420/bin/pint010255.f2_default.jpg
Fig 2 Trial profile of patients in study of effect of wound edge protection devices during laparotomy
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4793420/bin/pint010255.f3_default.jpg
Fig 3 Rates of surgical site infection by treatment group within 30 days in patients allocated to surgery with use of wound protection device (WEPD) or standard care
https://www.ncbi.nlm.nih.gov/pmc/articles/instance/4793420/bin/pint010255.f4_default.jpg
Fig 4 Subgroup analyses for primary outcome in patients allocated to surgery with use of wound protection device (WEPD) or standard care

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Source: PubMed

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