Study Outcomes
The primary efficacy outcome was the recurrence of infection, defined as persistent infection, the presence of a pocket abscess with or without the need for surgical drainage or reintervention, or infection of a newly implanted device. The primary safety outcome was hematoma formation. Secondary outcomes included any adverse reaction to chlorhexidine (including allergic reactions and skin reactions), the need for reintervention (including surgical hematoma or abscess drainage), infection-related mortality, and total procedural time.