Operating Room Air Filtration/Sterilization

Not Applicable

Active, not recruiting

• Conditions: Surgery
• Interventions: Device: Functioning Aerus air filtration/sterilization; Device: Deactivated Aerus air filtration/sterilization

• Registration Number: NCT04610294
• Lead Sponsor: The Cleveland Clinic

Brief 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.

Study Timeline

• Study First Submitted: 2020-10-26
• Study First Submitted QC: 2020-10-26
• Study First Posted: 2020-10-30
• Study Start: 2021-05-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-10
• Primary Completion: 2025-08
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 66273

Inclusion Criteria

• All patients in designated adult operating rooms
• American Society of Anesthesiologists physical status 1-4.
• Surgery lasting at least 1 hour.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Aerus air sterilization	Functioning Aerus air filtration/sterilization	Aerus air sterilization system will be used in an operating room, in addition to routine room air filtration
Conventional air handling	Deactivated Aerus air filtration/sterilization	Only routine room air filtration will be used in an operation room.

Primary Outcome Measures

Name	Time	Method
Serious surgical site infections and related complication in previously uninfected surgical inpatients	30 days after surgery	Composite of serious surgical site infections, infection-related complications, and death in surgical inpatients without present-on-admission composite infection components

Secondary Outcome Measures

Name	Time	Method
Serious surgical site infections and related complication in previously uninfected surgical inpatients and outpatients	30 days after surgery	Composite of serious surgical site infections, infection-related complications, and death in surgical inpatients and outpatients without present-on-admission composite infection components

Trial Locations

Locations (1)

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States