Determine whether operating room air filtration and sterilization with the ActivePure system reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery.
The investigators primary goal is thus to determine whether supplemental filtering and sterilizing operating room air reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery. The primary outcome will be restricted to inpatients. However, outpatients will be simultaneously enrolled given the trial's cluster design. Sample-size is based on our primary inpatient analysis, N= 66,273 inpatients. Available outpatients will be included for analysis of our secondary outcome which includes both inpatients and outpatients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
66,273
Two units of Aerus air sterilization system will be used in each operating room, and each will be set to "high." Units used for the trial will be modified internally to be active and will be sealed to prevent operating room personnel from opening the system and determining a unit's status.
Two units of Aerus air sterilization system will be used in each operating room, and each will be set to "high." Units used for the trial will be modified internally to be inactivated and will be sealed to prevent operating room personnel from opening the system and determining a unit's status. Units will be inactivated by removing the activated carbon, high-efficiency particulate filter, and ionization chamber. However, the fan will remain active as will the "run" lights.
Cleveland Clinic
Cleveland, Ohio, United States
Serious surgical site infections and related complication in previously uninfected surgical inpatients
Composite of serious surgical site infections, infection-related complications, and death in surgical inpatients without present-on-admission composite infection components
Time frame: 30 days after surgery
Serious surgical site infections and related complication in previously uninfected surgical inpatients and outpatients
Composite of serious surgical site infections, infection-related complications, and death in surgical inpatients and outpatients without present-on-admission composite infection components
Time frame: 30 days after surgery
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