A randomized controlled trial for the prophylaxis of infection after cardiac implanted device replacement

Of the 195 patients included (mean age 70.2 ± 13.6years, 55.4% women), with an average follow-up period of 54.3±28.9 months. The primary outcome occurred in 4 (2.1%), and there was no significant difference between the two groups (3.1% vs 1.0%, p=0.606). Hematoma was occurred in 10 patients (3.1% vs 7.1%, p=0.338), one of them required wound revision. In multivariable analysis, the occurrence of hematoma was the only independent risk factor associated with device infection. (HR 13.6, 95% CI 1.02-181.15, p=0.048)