Surgery · 3 h ago
ORACLE Trial Finds No Infection Benefit from Supplemental Operating-Room Air Purification
In the cluster-randomized, blinded ORACLE trial, 110,538 surgical patients were enrolled across 68 operating rooms; 107,334 qualified for analysis. Supplemental active air purification did not reduce the composite of surgical wound infection, infection-related complications, or death within 30 days.
- The blinded cluster-randomized trial included 68 operating rooms.
- Inpatient composite outcomes occurred in 8.1% versus 8.2%.
- No significant benefit was found across inpatient and outpatient surgeries.
- ActivePure funded the study and approved the original protocol.
The ORACLE trial randomized operating rooms in four-week blocks to active supplemental air purification or an identical-looking sham device. Investigators, clinicians, and patients were blinded. The analysis included adults undergoing surgery lasting at least one hour without evidence of a pre-existing wound infection. The primary outcome was a composite of surgical wound infection, infection-related complications, or death within 30 days after inpatient surgery; the same composite across inpatient and outpatient procedures was a secondary outcome.
Across 68 operating rooms, 110,538 patients were enrolled and 107,334 qualified for analysis. Enrollment stopped after a planned interim analysis crossed the futility boundary. Among inpatients, the primary composite occurred in 8.1% of the active-purification group and 8.2% of the sham group (odds ratio 0.98; 95% CI 0.92–1.05; P=0.609). Across all patients, rates were 5.5% and 5.6%, respectively (odds ratio 0.98; 95% CI 0.93–1.05; P=0.669).
The findings do not show a reduction in these outcomes from supplemental air purification in the populations studied. The trial was funded by a grant from ActivePure to the Cleveland Clinic; the company approved the original protocol but was not involved in data acquisition, analysis, or manuscript preparation. The authors suggest focusing infection-control efforts on limiting direct wound contamination.
In practice
For adults undergoing surgery lasting at least an hour without pre-existing wound infection, this large blinded cluster-randomized trial found no reduction in the 30-day composite of surgical wound infection, infection-related complications, or death with supplemental operating-room air purification. The close event rates and confidence intervals provide no evidence of benefit in the populations studied, although they do not establish equivalence for every procedure or setting. The findings do not support adding this intervention to prevent the measured outcomes on the basis of this trial.
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Anesthesiology: Operating Room Air Filtration-Sterilization and Surgical Infections: The ORACLE Randomized Trial in 110,538 Surgeries ↗This is an automated AI-condensed summary that has not yet been reviewed by an editor. Always consult the full item at the original source.