NCT04610294

Operating Room Air Filtration/Sterilization

Operating Room Air Filtration/Sterilization and Surgical Site Infection: A Randomized Multiple Cross-over Cluster Trial

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 66,273 (estimated)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Surgery

Interventions

Type	Name	Description
DEVICE	Functioning Aerus air filtration/sterilization	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.
DEVICE	Deactivated Aerus air filtration/sterilization	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.

Timeline

• Start date: 2021-05-01
• Primary completion: 2026-01-01
• Completion: 2026-12-01
• First posted: 2020-10-30
• Last updated: 2025-10-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study