Operating Room Air Filtration/Sterilization

Surgery Clinical Trial

— ORACLE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04610294
• Other study ID #: 20-656
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: October 2023
• Source: The Cleveland Clinic
• Contact: Fabio Rodriguez Patarroyo, MD
• Phone: ?(216) 507-3610?
• Email: Rodrigf3[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 66273
• Est. completion date: December 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients in designated adult operating rooms

• American Society of Anesthesiologists physical status 1-4.

• Surgery lasting at least 1 hour.

Related Conditions & MeSH terms

• Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Cleveland Clinic	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	30 days after surgery
Secondary	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	30 days after surgery