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Operating Room Air Filtration/Sterilization

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ClinicalTrials.gov Identifier: NCT04610294
Recruitment Status : Not yet recruiting
First Posted : October 30, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
The Cleveland Clinic

Study Description
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Brief Summary:
Determine whether operating room air filtration and sterilization with the Aerus system reduces a composite of serious surgical site infections, infection-related complications, and death within 30 days after surgery.

Condition or disease Intervention/treatment
Non-cardiac Surgery Device: Functioning Aerus air filtration/sterilization Device: Deactivated Aerus air filtration/sterilization

Detailed Description:
The investigators primary goal is thus to determine whether 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 investigators will determine the effect of air filtration and sterilization on serious surgical site infections, and on the cost of care. infections, and on the cost of care.
Study Design
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Study Type : Observational
Estimated Enrollment : 86639 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Operating Room Air Filtration/Sterilization and Surgical Site Infection: A Randomized Multiple Cross-over Cluster Trial
Estimated Study Start Date : May 2021
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : June 2024

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Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
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.


Outcome Measures
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Primary Outcome Measures :
  1. Composite outcome of postoperative complications [ Time Frame: 30 days after surgery ]
    A composite of mortality, major surgical site infection, and healing-related wound complications


Secondary Outcome Measures :
  1. Serious surgical site infection [ Time Frame: 30 days after surgery ]
    Deep or organ-space surgical site infection will be evaluated by analysis of International Classification of Disease revision 10 (ICD-10) diagnosis codes

  2. Cost-of-care [ Time Frame: 30 days after surgery ]
    Our economic analysis will estimate the cost-effectiveness ratio, defined as the difference in average total hospital costs divided by the difference in the proportion with any of the components of the composite, and expressed as average cost per 1 percent improvement in the composite outcome.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
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.
Criteria

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:

  • patients with present-on-admission infections
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04610294


Contacts
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Contact: Roberta Johnson 216-444-9950 johnsor13@ccf.org
Contact: Mauro Bravo, MD 216-636-9449 bravom2@ccf.org

Locations
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United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Roberta Johnson    216-444-9950    johnsor13@ccf.org   
Contact: Mauro Bravo, MD    216-636-9449    bravom2@ccf.org   
Principal Investigator: Daniel I Sessler, MD         
Sponsors and Collaborators
The Cleveland Clinic
Investigators
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Principal Investigator: Daniel I Sessler, MD The Cleveland Clinic
More Information
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Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT04610294    
Other Study ID Numbers: 20-656
First Posted: October 30, 2020    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Device Product: No