ROSSINI 2 is a multi-arm, multi-stage (MAMS) pragmatic, multicentre, RCT exploring the use of three separate in-theatre interventions to reduce SSI. It’s non-factorial design, allocation of various combinations of the three interventions are to be used during the same operation, via eight possible treatment arms initially (See diagram above). Predefined interim analyses will be undertaken at two points during the trial; two arms will be dropped after each analysis using a composite analysis of clinical effectiveness and adherence to arm allocation.
The study is funded by the National Institute for Health Research (NIHR) Health Technology Assessment and is sponsored by Birmingham Clinical Trials Unit. More information about the trial and how to join can be found here.
Chief Investigator: Mr Thomas Pinkney