The ROSSINI-Platform Trial: A basket factorial multi-arm multi-stage (MAMS) platform randomised controlled trial (RCT) to evaluate the use of multiple interventions to reduce surgical site infection (SSI) across several types of surgery.

We will open 100 hospitals across the UK and recruit 26,000 patients undergoing surgery in 6 surgical specialties (‘pillars’): ​

• Vascular groin, ​
• Lower limb amputation (LLA),​
• Obstetric, ​
• Breast, ​
• Neurosurgery, or​
• Cardiac Surgery.

Consisting of 6 individual full-scale pragmatic, outcome assessor blinded, stratified, multi-arm multi-stage 2x2x2 factorial RCTs, which means a total, of 18 interventions are being assessed in the trial, with examples including:

• using state-of-the-art wound cleaning solutions during surgery
• using special wound dressings after surgery,
• applying antibiotics differently during surgery,
• changing gloves and instruments at certain points during surgery,
• waxing or epilation around the surgical site

To determine whether several specific peri-operative interventions result in decreased risks of SSI, up to 30 days postoperatively, in patients undergoing surgery across different surgical specialties including: ‘vascular groin’, lower limb amputation (LLA), breast, cardiac surgery, obstetrics and neurosurgery.

Primary Outcome:

SSI within 30 days of surgery according to the modified Centers for Disease Control (CDC) criteria, assessed by local research teams at hospital discharge and then remotely through the CDWH augmented by patient questionnaires and wound photographs collected weekly via a patient-facing App.

Secondary Outcomes:

• 30-day and 90-day postoperative mortality rate (POMR).
• 30-day postoperative worst wound complication (Clavien-Dindo or / Landriel-Ibanez classification).
• Risk of wound-related or intervention-related Serious Adverse Events up to 30 and 90 days post-surgery.
• Length of hospital stay after surgery as measured from the date of surgery to the date fit for discharge collected via hospital records.
• Risk of hospital re-admission for wound related complications within 30 and 90 days post-discharge.
• Risk of wound reopening and/or re-operations within 30 and 90 days post-surgery.
• Preference-based Quality of Life (QoL EQ-5D-5L) at Baseline, Day of Discharge and weekly until Day 30 post-surgery via Isla.
• Cost effectiveness (Resource Use Questionnaire; RUQ).

A multi-speciality ‘Basket Factorial MAMS’ platform trial, in which multiple phase III factorial MAMS RCTs will be run in parallel within different surgical cohorts (‘pillars’), under one overall master protocol and governance structure. Individual trials in each pillar are pragmatic, MAMS 2x2x2 factorial RCTs with blinded assessment of outcomes. Internal pilot phases are planned at platform, pillar and intervention levels.

The Trial is receiving £10 million funding over 5 years from NIHR

27th February 2025: University of Birmingham: "Largest ever UK surgical trial to make future operations safer"

To express an interest in taking part, or to request more information on the trial, please contact the ROSSINI Platform study team:

 rossini-platform@contacts.bham.ac.uk