SurgeryORACLENCT04610294
Operating Room Air Filtration/Sterilization
A study testing Functioning Aerus air filtration/sterilization and Deactivated Aerus air filtration/sterilization in people with Surgery, run by The Cleveland Clinic at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Surgery
- What is being tested?
- Functioning Aerus air filtration/sterilization and Deactivated Aerus air filtration/sterilization
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66,273 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2021to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients in designated adult operating rooms
- American Society of Anesthesiologists physical status 1-4.
- Surgery lasting at least 1 hour.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Being tested
- Functioning Aerus air filtration/sterilization, Deactivated Aerus air filtration/sterilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functioning Aerus air filtration/sterilizationDevice
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/sterilizationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Aerus air sterilization | Experimental | Aerus air sterilization system will be used in an operating room, in addition to routine room air filtration Receives: Device: Functioning Aerus air filtration/sterilization |
| Conventional air handling | Active comparator | Only routine room air filtration will be used in an operation room. Receives: Device: Deactivated Aerus air filtration/sterilization |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 30 days after surgery
Secondary outcomes (1)
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
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study start1 May 2021
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized multiple crossover cluster trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66,273 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I Sessler, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610294
- Sponsor's protocol ID
- 20-656
- Acronym
- ORACLE
- Status last verified
- Oct 2025
- First submitted
- 26 Oct 2020
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Patient level data will be shared collaboratively. Sharing will require approval of the trial steering committee and appropriate institutions approvals and data-sharing contracts.
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Operating Room Air Filtration/Sterilization and Surgical Site Infection: A Randomized Multiple Cross-over Cluster Trial
- ClinicalTrials.gov ID
- NCT04610294
- Acronym / sponsor ID
- ORACLE / 20-656
- Conditions
- Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 66,273 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized multiple crossover cluster trial
| Arm | Type | Receives |
|---|---|---|
| Aerus air sterilization | Experimental | Device: Functioning Aerus air filtration/sterilizationAerus air sterilization system will be used in an operating room, in addition to routine room air filtration |
| Conventional air handling | Active comparator | Device: Deactivated Aerus air filtration/sterilizationOnly routine room air filtration will be used in an operation room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients in designated adult operating rooms
- American Society of Anesthesiologists physical status 1-4.
- Surgery lasting at least 1 hour.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functioning Aerus air filtration/sterilizationTwo 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 | Aerus air sterilization |
| Deactivated Aerus air filtration/sterilizationTwo 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. | Device | Conventional air handling |
Primary outcome
Serious surgical site infections and related complication in previously uninfected surgical inpatients
Time frame: 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
1 secondary outcome
Serious surgical site infections and related complication in previously uninfected surgical inpatients and outpatients
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Individual participant dataSharing planned: Yes. Patient level data will be shared collaboratively. Sharing will require approval of the trial steering committee and appropriate institutions approvals and data-sharing contracts.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel I Sessler, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functioning Aerus air filtration/sterilization and Deactivated Aerus air filtration/sterilization in people with Surgery, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serious surgical site infections and related complication in previously uninfected surgical inpatients (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 28 Oct 2026.