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.