A central venous catheter with a new form of silver impregnation of the internal and external surfaces was investigated for antimicrobial activity and tolerance in patients in a controlled comparative, prospective and randomized clinical study. Commercially available catheters with no antimicrobial activity were used as controls. One hundred sixty-five catheters were included in the final evaluation. All catheters were percutaneously inserted for the first time with a duration of > or = 5 days and a microbiological examination of the catheter tip. Catheter location (> 90% internal jugular vein), mean duration of catheterization (8-9 days), patients' age and diagnosis were comparable in both groups. Silver-impregnated catheter tips showed an incidence of colonization in 14.2/1000 catheter days and control catheters in 22.8/1000 catheter days. This represents a reduction of 37.7%. Catheter-associated infections were diagnosed in the silver group in 5.26/1000 catheter days and 18.34/1000 catheter days in the control group, indicating a reduction rate of 71.3% (P < 0.05, chi 2-test). No complications or side effects were documented in either group.

The antimicrobial activity of a silver-impregnated polymer catheter (the Erlanger silver catheter) was demonstrated by determining the microbial adhesion to the surface of the catheter and by measuring the rate of proliferation (viability) of microorganisms at this site. On the surface of a catheter impregnated with silver, according to previously described methods, the bacterial adhesion of Staphylococcus epidermidis is reduced by 28-40%. Bacterial proliferation on the surface of the catheter and biofilm production are also substantially reduced by the elution of free silver ions from the catheter matrix. Bacteriostatic and bactericidal activities can be determined. The antimicrobial efficacy of the silver catheter is not reduced by blood components. There is no loss in antimicrobial activity for weeks after preincubation in water or phosphate buffered saline. The antimicrobial activity depends on the extent of the active silver surface.

Central venous long-term catheters offer reliable, large-lumen vascular access with high flow rates for delivery of nutrition or for cell-containing infusions and perfusions. Catheter-associated infections (CAI) pose the greatest threat to such vascular access, despite existing preventive measures. In this article one prospective and one retrospective study of CAI in pediatric therapy are presented. Study I: A retrospective investigation from 1990 through 1995 of 60 conventional long-term catheters in 50 patients. The total number of days in which the catheters were in place was 11,818. The calculated CAI incidence was 1 per 1,000 days of catheter insertion. Bacteriologically demonstrated CAI (identical isolate on the catheter tip and in a blood culture) occurred in three instances (5%). Five cases (8.3%) were diagnosed with a therapy-resistant, septic clinical picture. Study II: A prospective, randomized comparison of long-term silver-impregnated (Erlanger silver catheters) and control catheters (Quinton Instrument Co.) was made with 41 patients (20 with a silver catheter, 21 with a Quinton catheter). To date, the silver catheters have been distinguished by sterile bacteriological findings, whereas three cases of CAI have been demonstrated with the comparative catheters. One patient recently underwent intensive care after becoming unstable with signs of septic shock and demonstrable Pseudomonas aeruginosa, and two other patients manifested coagulase-negative staphylococci on the catheter tips. In three of nine control catheters an incidence of 1.18 per 1,000 days of indwelling catheters was found, whereas no CAI has occurred with the eight microbiologically tested silver catheters.

To date there have been no standard methods for assessing the thrombogenicity of central venous catheters. A procedure for testing the thrombogenicity of intravenous lines such as the silver-impregnated catheter by continuous blood flow in vitro was therefore developed. For this test, fresh blood was drawn from healthy human donors and anti-coagulated with sodium citrate (1:9). All material tested (catheter tubes with and without silver manufactured in the same way, polyethylene tubes and tubes with potentially thrombogenic material) were perfused through their lumen with anticoagulated blood for up to 31 hours. Blood samples were collected at different times from the test system at sites before and after the perfusion of the test catheters. The hemoglobin concentration, erythrocyte, leukocyte and thrombocyte counts and markers for thrombin activation (thrombin-antithrombin III-complex, F1 + 2)-prothrombin fragments) and for hyperfibrinolysis (d-dimers) were determined. No thrombin activation or signs of hyperfibrinolysis were detected in any material tested. Polyethylene tubes were found to cause hemolysis, as shown by a decrease in hemoglobin content from 15 g% to 4.5 g%. Tecothane tubes with and without silver did not induce hemolysis.

The Erlanger silver catheter consists of a new form of polyurethane, which contains finely dispersed metallic silver. The aim of this study was to establish the biocompatibility of this intravenous catheter by investigating the acute cytotoxicity of extracts from the Erlanger silver catheter on human fibroblasts and lymphocytes. Extracts of the Erlanger silver catheter were not cytotoxic for MRC-5 human fibroblasts nor for sensitized phytohemagglutinin (PHA)-stimulated human lymphocytes. The addition of silver powder of up to 2% by weight to the basic catheter polyurethane Tecothane led to no increase in acute cytotoxicity in comparison with untreated Tecothane. The Erlanger silver catheter is a new intravenous catheter with good biocompatibility.