Clinical trials of a new polytetrafluoroethylene-silicone graft

A self-sealing polytetrafluoroethelene (PTFE)-silicone graft designed to be used early after implantation was placed in 30 end-stage renal disease patients. Thirty-five conventional PTFE grafts were used in the control group. All patients were followed for 1 year. In the PTFE-silicone graft group, median time for first use was 1 day after implantation. Conventional PTFE grafts were first used 2 to 4 weeks after implantation. Early punctures of the PTFE-silicone grafts (first 10 sessions), although more difficult to perform than late punctures, were not more difficult than punctures of conventional PTFE grafts. Late punctures in PTFE-silicone grafts were easier than conventional PTFE graft punctures. Bleeding after needle removal was significantly decreased after early and late punctures of PTFE-silicone grafts compared with conventional PTFE grafts (p less than 0.001). The PTFE-silicone graft can be used immediately after implantation, sparing patients additional access procedures for short-term dialysis. This results in less morbidity, decreased bleeding complications, shorter hospital stay, and a significant reduction in expenses.