Operating Room Air Filtration/Sterilization

NCT04610294 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 20-656
• Study Type: interventional
• Target: 66,273
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Serious surgical site infections and related complication in previously uninfected surgical inpatients and outpatients

  30 days after surgery

Study Arms (2)

Aerus air sterilization

EXPERIMENTAL

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

Device: Functioning Aerus air filtration/sterilization

Conventional air handling

ACTIVE COMPARATOR

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

Device: Deactivated Aerus air filtration/sterilization

Interventions

Deactivated Aerus air filtration/sterilization DEVICE

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.

Conventional air handling

Functioning Aerus air filtration/sterilization DEVICE

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.

Aerus air sterilization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Interventions

Sterilization, Reproductive

Intervention Hierarchy (Ancestors)

Contraception; Reproductive Techniques; Therapeutics; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Daniel I Sessler, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Identical-looking test devices are either active or inactive. None of the investigators, clinicians, patients, or outcome assessors knows which are which.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized multiple crossover cluster trial

Study Record Dates

• First Submitted: October 26, 2020
• First Posted: October 30, 2020
• Study Start: May 1, 2021
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 1 year after publication of the main trial paper.
• Access Criteria: Contact principal investigator.

Locations

US (1)