ROSSINI 2 is a Multi-arm, multi-stage (MAMS) pragmatic, multicentre, randomised controlled trial, with an internal pilot, exploring the use of three separate in-theatre interventions, use alone or in combination, to reduce SSI. A non-factorial design with allocation of various combinations of the three interventions to be used during the same operation, via seven possible intervention arms plus a control arm initially.
The trial would be the first of its kind in a surgical setting. In addition to generating new knowledge in our primary research area, by utilising this advanced design in the context of our relatively simple primary endpoint of SSI, it will also pave the way for future efficient and rapid trials in other aspects of surgical care.
The three interventions chosen in ROSSINI 2 impact different phases of perioperative case and as such can be used either in isolation or in conjunction with each other and although there may potentially be interaction between the interventions (positive or negative) they appear to be mechanistically disparate.
The interventions are:
- 2% alcoholic chlorhexidine skin prep
- Iodophor-impregnated incise drapes
- Gentamicin-impregnated implants/sponge
10 local NHS hospitals will participate in the pilot phase of ROSSINI 2 and at least 60 NHS hospitals in the UK will participant in the main phase of ROSSINI 2.
Approximately 6610 patients will be required to detect a 5% absolute risk reduction in the interventions arm(s) (15% to 10%) with 85% power.