The ASPIRE-SSI study team is happy to announce the enrollment completion of the anticipated 5,000 subjects in the study. After an enrollment period of nearly 3 years, the 5.000th subject was enrolled on 30 October 2019. This is a major achievement for the team and the COMBACTE community.
Logistical challenges and Flexibility
Exactly one year after its WP6a companion-study, ASPIRE-ICU, finished recruitment, ASPIRE-SSI completed its recruitment phase. The ASPIRE-SSI study was conducted in 33 hospitals across 10 countries in the European Union. Patients participating in the study underwent one of the following types of surgery: craniotomy, mastectomy, open cardiac surgery, ICD implantation, trauma surgery and emergency, hip prosthesis surgery, knee prosthesis surgery, laminectomy, spinal fusion, central artery reconstruction surgery or peripheral artery bypass. It is truly a great achievement of the local teams who performed screening and follow-up activities, with many different wards and departments from their institutions involved. Flexibility and expertise of the CLIN-Net research teams has been shown with this study during the past three years!
About 10% of the 5000 patients are still in active follow-up and the last patient is projected to complete the follow-up period of the study at the end of January 2020. In the meantime, the study team is focused on final data collection and cleaning. Once sample collection is completed, the local teams will be consulted by the central lab on the organisation of the transport to LAB-Net at the University of Antwerp. The central lab will check for completeness and generate queries if applicable. Also during this last phase of the study, the ASPIRE-SSI team continues to work closely with the local teams to resolve the last queries, and everyone is looking forward to database lock in early 2020.
The ASPIRE-SSI study team is proud of the enormous number of collaborating experts who have made the enrollment in this study a success. This includes investigators, sub-investigators, research nurses, microbiologists, lab staff, COMBACTE partners, collaborating national coordinators, and of course the patients who participated in the study.
This milestone was achieved thanks to the tremendous dedication and hard work of all those involved. A long journey made possible by their continuous commitment!
ASPIRE-SSI (Advanced understanding of StaPhylococcus aureus Infections in EuRopE – Surgical SiteInfections) is a prospective, observational, multicenter cohort study performed with adult surgical patients as subjects. The study aims to engender advanced understanding of Staphylococcus aureus infections in Europe (ASPIRE) incurred in surgical site infections (SSIs).