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Table 13 PADIT: prevention of arrhythmia device infection

From: Heterogeneity in pragmatic randomised trials: sources and management

Patients: Patients with an implanted medical device

Centres: 28 Canadian centres

Intervention: Incremental periprocedural antibiotics, i.e. pre-procedural cefazolin plus vancomycin, intraprocedural bacitracin pocket wash, and 2-day post-procedural oral cephalexin

Control: Conventional periprocedural antibiotics, i.e. pre-procedural cefazolin infusion

Outcome: 1-year hospitalisation for device infection

Design: Cluster randomised cross-over trial

Ethical requirements

“All centers’ ethics boards approved the trial with waiver of consent for treatment. Ten centers required patient consent for data collection, which was generally obtained during follow-up.”