Operating Room Air Filtration/Sterilization (ORACLE)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Surgery
• Intervention / Treatment: Device: Functioning Aerus air filtration/sterilization; Device: Deactivated Aerus air filtration/sterilization

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 Type: Interventional
• Enrollment (Estimated): 66273
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

The trial will take place in the adult operating rooms of the Cleveland Clinic Main Campus, specifically ORs 1-25 in E and 28-38 in H, 40-50 in G, and J operating rooms. Because of the cohort design, all patients who have surgery in these operating rooms will be included.

Description

Inclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Aerus air sterilization; Aerus air sterilization system will be used in an operating room, in addition to routine room air filtration	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.
Active Comparator: Conventional air handling; Only routine room air filtration will be used in an operation room.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Daniel I Sessler, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 26, 2020
• First Submitted That Met QC Criteria: October 26, 2020
• First Posted (Actual): October 30, 2020

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 1, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Therapeutics; Surgical Procedures, Operative; Reproductive Techniques; Urogenital Surgical Procedures; Contraception; Sterilization, Reproductive
• Other Study ID Numbers: 20-656

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient level data will be shared collaboratively. Sharing will require approval of the trial steering committee and appropriate institutions approvals and data-sharing contracts.
• IPD Sharing Time Frame: 1 year after publication of the main trial paper.
• IPD Sharing Access Criteria: Contact principal investigator.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No