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
|Condition or disease||Intervention/treatment|
|Non-cardiac Surgery||Device: Functioning Aerus air filtration/sterilization Device: Deactivated Aerus air filtration/sterilization|
|Study Type :||Observational|
|Estimated Enrollment :||86639 participants|
|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|
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.
- Composite outcome of postoperative complications [ Time Frame: 30 days after surgery ]A composite of mortality, major surgical site infection, and healing-related wound complications
- 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
- 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.
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
|Contact: Roberta Johnsonemail@example.com|
|Contact: Mauro Bravo, MDfirstname.lastname@example.org|
|Principal Investigator:||Daniel I Sessler, MD||The Cleveland Clinic|