ROSSINI 2 - Reduction of Surgical Site Infection Using Several Novel Interventions
Status:
Recruiting
Trial end date:
2022-02-01
Target enrollment:
Participant gender:
Summary
This is a Phase III, multi-arm, multi-stage (MAMS) pragmatic, blinded (patient and outcome
assessor) multicentre, randomised controlled trial (RCT) with an internal pilot, to evaluate
the use of three in-theatre interventions to reduce SSI rates in patients undergoing surgery
with an abdominal incision. ROSSINI 2 is a non-factorial superiority design with allocation
of various combinations of the three interventions to be used during the same operation, via
seven possible treatment arms plus one control arm initially.
Phase:
Phase 3
Details
Lead Sponsor:
University of Birmingham
Collaborators:
National Institute for Health Research, United Kingdom University College, London