Operating Room Air Filtration/Sterilization (ORACLE)

NeuroTherapia, Inc.

Status: Active, not recruiting

Conditions: Surgery

Treatments: Device: Functioning Aerus air filtration/sterilization; Device: Deactivated Aerus air filtration/sterilization

Study type: Interventional

Funder types: Other

Identifiers

NCT04610294

20-656

Details and patient eligibility

About

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.

Full 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.

Enrollment: 66,273 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• All patients in designated adult operating rooms
• American Society of Anesthesiologists physical status 1-4.
• Surgery lasting at least 1 hour.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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66,273 participants in 2 patient groups

Aerus air sterilization

Experimental group

Description:

Aerus air sterilization system will be used in an operating room, in addition to routine room air filtration

Treatment:

Device: Functioning Aerus air filtration/sterilization

Conventional air handling

Active Comparator group

Description:

Only routine room air filtration will be used in an operation room.

Treatment:

Device: Deactivated Aerus air filtration/sterilization