ROSSINI-Platform - Reduction of surgical site infection with a platform trial utilising a 'Basket-MAMS' design - Application acceleration award

<ns3:p>Background Surgical site infection (SSI) is the most common surgical complication, resulting in significant morbidity, mortality, and major costs to health service providers. Multi-arm, multi-stage (MAMS) trials allow multiple individual interventions to be evaluated simultaneously, rendering them highly efficient at both speed and cost. Our group is running the successful ROSSINI 2 MAMS trial in abdominal SSI reduction, which was funded by HTA and proved that such trials are deliverable and effective in a modern surgical context. Our proposed platform study will run multiple parallel RCTs in different surgical cohorts, utilising a ‘Basket-MAMS’ design to simultaneously assess multiple interventions and will share learning between cohorts to take successful arms from one area to another for rapid testing. This would provide robust and context-specific evidence for rapidly improving patient care. Methods We identified a list of key methodological, logistical, health economic, PPI-related, and clinical design challenges. A large study team was assembled, consisting of both core experts and national clinical research leaders, including robust plans for capacity building, Chief Investigator (CI) development, and multi-level PPI engagement. The working groups designed a series of parallel work packages to address the identified challenges, both centrally and in clinical networks, convening regularly to discuss and plan the full application. Iterative modifications and improvements to the overall proposal were allowed and encouraged. Results We report the progress, activities undertaken, and decisions made throughout the application acceleration award project. This information may be beneficial to planning or preparing a similar large-scale and multi-specialty platform trial. Conclusions The acceleration grant allowed us to design a fundable and deliverable clinical trial for the HTA platform trial call in late 2023. The full trial has the potential to significantly impact the rates of this highly impactful complication, thereby benefitting both patients and health services worldwide.</ns3:p>