Aerus Medical formally announced the start of a double-blind two-year clinical study to evaluate the impact the Aerus Medical Guardian with ActivePure Technology can have on reducing nosocomial infections, or healthcare-associated infections, also known as HAIs, from surgical operating room procedures.
Aerus Medical Guardian with ActivePure Technology, a U.S. FDA Class II Medical Device, reduces bacteria and viruses in the air by 99.99% within 30 minutes and surface contamination by more than 99% after several hours. The primary goal of the randomized trial will be to determine whether filtering and sterilizing operating room air with the Aerus Medical Guardian with ActivePure Technology air purifier reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery. Secondarily, the trial will determine the effect of air filtration and sterilization on serious surgical site infections and on the cost of care.
HAIs are a significant concern that can have serious medical, emotional, and financial consequences. These types of infections cost the U.S. healthcare system billions of dollars each year. According to the Centers for Disease Control and Prevention, on any given day, about one in 31 hospital patients has at least one HAI.
The Aerus Medical Study will use 50 noncardiac, adult operating rooms at Cleveland Clinic. The trial will be restricted to adults aged 18 years or older, having surgery lasting at least one hour. Patients with present-on-admission infections will be excluded from the study. Operating rooms will be randomized in one-month blocks to Aerus air sterilization or conventional air handling. A minimum of 67,653 patients with a maximum of 86,639 patients will be needed for this study.
The trial is expected to begin this year and last approximately two years.
The Aerus Medical Guardian with ActivePure Technology is roughly the size and configuration of carryon luggage (26.5″H x 11.5″W x 21.0″D) and weighs 48 pounds. It cleans 18,000 cubic feet of air per hour on its “high” setting. The system actively cleans the air with activated carbon, ActivePure Molecules, and high-efficiency particulate filtration.
The Aerus Medical study is sponsored by Aerus Medical LLC, the company that developed the surface and air purification unit Aerus Medical Guardian with ActivePure Technology.