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.” |