Operating Room Air Filtration/Sterilization

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Surgery

Intervention / Treatment
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* Device: Functioning Aerus air filtration/sterilization
* Device: Deactivated Aerus air filtration/sterilization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients in designated adult operating rooms American Society of Anesthesiologists physical status 1-4. Surgery lasting at least 1 hour.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized multiple crossover cluster trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aerus air sterilization<br>Aerus air sterilization system will be used in an operating room, in addition to routine room air filtration | Device: Functioning Aerus air filtration/sterilization<br>* 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.<br>|
| Active Comparator: Conventional air handling<br>Only routine room air filtration will be used in an operation room. | Device: Deactivated Aerus air filtration/sterilization<br>* 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.<br>|

What is the study measuring?
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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 |