Outcomes
The primary effectiveness outcome (infection recurrence) occurred in 4 patients (4.3%) who died from worsening sepsis: 3 in the capsulectomy group and 1 in the CHG group (p=0.346). Individual characteristics of patients who died of sepsis are included in Table 3 . There were no cases of reinfection of newly implanted devices or need for reintervention due to local infection. The primary safety outcome (hematoma formation) occurred in 7 patients (13%) in the capsulectomy group vs. none in the CHG group (p=0.014). There were no immediate or 30-day complications associated with chlorhexidine use. Consequently, post-procedural complications (i.e., hematoma or recurrent infection) were significantly more frequent in patients undergoing capsulectomy than in patients undergoing CHG scrubbing. The procedural time was significantly longer in patients undergoing capsulectomy (133.7±78.5vs. 89.9±51.8 minutes, p=0.002) (Central Illustration).