Operating Room Air Filtration-Sterilization and Surgical Infections: The ORACLE Randomized Trial in 110,538 Surgeries
Primary result · Collapsed composite of surgical wound infections, infection-related complications, or death (inpatients)Result — go to the resultOdds ratio 0.98 95% CI 0.92–1.05Authors' conclusion
Supplemental active purification did not reduce surgical wound infections or mortality in surgical patients. Infection-control efforts might better focus on limiting direct wound contamination.Trial registration:A priori registration at ClinicTrials.gov: NCT04610294.Funding: Supported by a grant from ActivePure (Bristol, VA) to the Cleveland Clinic. The funder approved the original protocol which was written by the lead author. The funder was not involved in data acquisition, analysis, or manuscript preparation. A draft of the manuscript was provided to the funder as a courtesy.
Study context
- Population
- Adults who had inpatient or outpatient surgery lasting at least an hour without evidence of pre-existing wound infectionscombined inpatients and outpatients enrolled across 68 operating rooms, 107,334 qualifying for analysis · randomized inpatients 58,938
- Participants
- 110,538 adults
- Comparison
- Active vs identical-looking sham supplemental air sterilization
- Primary endpoint
- Collapsed composite of:
- Surgical wound infections
- Infection-related complications
- Death (inpatients)
- Follow-up
- Within 30 days after inpatient surgery
Methodological detailscluster (operating rooms) randomized in 4-week blocks, sham-controlled, fully blinded, intent-to-treat
- Cluster (operating rooms) randomized in 4-week blocks
- Sham-controlled
- Fully blinded
- Intent-to-treat
Primary result
As reported in the abstract
Odds ratio
0.98
95% CI 0.92–1.05
P = 0.609
Events by treatment group
Further findings
| Outcome | Active purification | Sham purification | Odds ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Secondary composite outcome, all patients (inpatient and outpatient) | 5.5% | 5.6% | 0.98 (0.93–1.05) | P = 0.669 | |
| 0.512Odds ratio (log scale) |
Treatment effect over time
- Treatment effect did not vary over the weeks in the randomized periods
Study conduct
- At the third interim analysis, the futility boundary on the composite outcome was crossed for inpatients and for all patients; enrollment stopped
Original publication
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