Clinical validation and efficacy of a temperature-controlled ventilation system (TcAF) in the OR to reduce surgical site infections

Abstract

Microbiological burden of room-air in operating theatres is a known risk factor for surgical site infections. However, it is unclear how to best evaluate efficacy and efficiency under routine clinical conditions. Moreover, there still is a lack of data to assess the impact on infection rates. The aim of this study was to evaluate a temperature-controlled ventilation system (TcAF) under routine clinical conditions and assess its impact on infection rates. 10 clinical installations of the TcAF system Opragon (Avidicare AB, Sweden) were assessed during live surgeries according to the Swedish SIS TS 39: 2015 standard. Furthermore, a retrospective analysis of 1,000 consecutive cases of primary total joint arthroplasty (hip, knee) before and 1000 after installation of the TcAF system was performed. Endpoints for clinical outcome were length of stay and infection rates. Our results show that requirements of the Swedish standard were met or significantly exceeded by the TcAF system reliably and robustly ensuring "ultra-clean" air in the entire operating theatre and demonstrating the capability to reduce the risk of airborne microbial transmission under routine clinical conditions. The study shows positive impact on key clinical outcome parameters in line with previous research by Charnley and Lidwell.

Keywords

• temperature controlled airflow
• surgical site infection (ssi)
• ultraclean air
• operating room