Surgery
Conditions
Brief 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.
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.
Interventions
DEVICEFunctioning 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.
DEVICEDeactivated 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.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Identical-looking test devices are either active or inactive. None of the investigators, clinicians, patients, or outcome assessors knows which are which.
Intervention model description
Randomized multiple crossover cluster trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients in designated adult operating rooms * American Society of Anesthesiologists physical status 1-4. * Surgery lasting at least 1 hour.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serious surgical site infections and related complication in previously uninfected surgical inpatients | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serious surgical site infections and related complication in previously uninfected surgical inpatients and outpatients | 30 days after surgery | Composite of serious surgical site infections, infection-related complications, and death in surgical inpatients and outpatients without present-on-admission composite infection components |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDaniel I Sessler, MD
The Cleveland Clinic
Outcome results
None listed