This is a Phase 3, randomized, double-blind, controlled, adaptive, 2-arm, multicenter study to demonstrate the efficacy and safety of DefenCath in adult participants receiving home Total Parenteral Nutrition (TPN) via Central Venous Catheter (CVC) compared with heparin.
Participants who are resident within the US and Türkiye.
Participants who are male or female, aged ≥18 years at the time of consent.
Participants must sign and provide informed consent.
Participants who have a permanent tunneled CVC or permanent peripherally inserted central catheter (PICC) made of silicone or polyurethane, which has been in place for at least 7 days prior to enrollment.
Any participant unable or not willing to sign inform consent.
Any participant who has received systemic antibiotic within the last 14 days. Topical antibiotics are permitted. Use of metronidazole or rifaximin for treating small intestinal bacterial overgrowth (SIBO) is also permitted.
Any participant with visible evidence of compromised skin integrity present at the catheter exist site or catheter exit site infection.
Any participant with temporary, non-tunneled CVC or temporary PICC.