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NEW surgical randomised clinical trial

ROSSINI2 - Reduction OSurgical Site Infection using several Novel Interventions 

A traineed led multi-arm, multi-stage pragmatic multicentre RCT

The need for this trial

Surgical site infection (SSI) is a significant problem for patients and the health service, but it is potentially preventable. SSI affects patients across all settings but is particularly prevalent in abdominal operations, where as many as 25% of patients get an SSI when the operation involves the bowel.  It has been estimated that SSIs currently cost the NHS around £700 million a year. There is a significant health need for research to address the problem of SSI, with benefit to both patients and the NHS. 

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Trial design

The ROSSINI 2 study will assess several interventions in the reduction of SSI. The trial builds on the success of the ROSSINI 1 trial which published in the BMJ in 2013. This was the first trial to come out of the West Midlands Research Collaborative (WMRC). This new study is a randomised controlled trial using a MAMS design. This innovative, efficient study will simultaneously investigate three in-theatre interventions. Patients will be randomly allocated to receive all, none or some of these in any combination.

Eligibility – abdominal surgery for any indication

Adults undergoing open abdominal surgery for any indication; including colorectal, hepatobiliary, upper GI, urological, vascular, gynaecological operations, via any incisions; both emergency and elective. Laparoscopic assisted surgery with an incision site greater than 5cm in length is also included.

Funder, the trial team, and current status

The trial is funded by the NIHR Health Technology Assessment (HTA) programme, and will be lead by CI Mr Thomas Pinkney. The co-ordinating centre for the trial is the Birmingham Clinical Trials Unit (BCTU). The team at BCTU and the WMRC are currently finalising the protocol and drafting CRFs, and the TMG met formally, in person, for the first time in October 2017.

Would your centre be interested in participating in the study?

If you would like to register your interest please email ROSSINI2@trials.bham.ac.uk. We will register your details and contact you at a later date with further information.

Consultants and trainees at individual sites involved in the research will be recognised as co-authors in future publications.

Initially NHS hospitals in the UK can register. Later there may be potential for expansion into Northern European countries with equitable healthcare systems, e.g. Denmark, Sweden, the Netherlands, and Germany.