Safety Evaluation of Bactiseal Antibiotic-Impregnated Catheter in Hydrocephalus Patients A Multi-Center Retrospective Study Over 2 Years

What this Trial Is About

Researchers are conducting a multi-center, retrospective study to continuously evaluate the safety of the Bactiseal catheter, an antibiotic-impregnated device used in patients with hydrocephalus. The study focuses on monitoring adverse events, including infections, that occur within two years after catheter implantation. It aims to collect data from medical records on the general and intraoperative conditions of patients and the catheters performance. The study involves hydrocephalus patients who have had the Bactiseal catheter implanted to shunt cerebrospinal fluid. This single-arm study will retrospectively enroll 200 subjects who received the catheter between January 1, 2019, and June 30, 2022. Data collected includes adverse events, bacterial cultures, and drug resistance tests if infections occurred. Participants medical information will be reviewed for up to two years following catheter implantation. Researchers will assess safety outcomes and infections related to the catheter. Information on previous surgeries, catheter details, and postoperative complications will be gathered to better understand the devices safety. The study does not involve additional interventions or visits, as it is based on existing medical records.

Bactiseal Catheter Safety Registry Study