Development and characterization of an infection inhibiting urinary catheter.

Catheter associated bacturia is common in hospitals and nursing homes. The objective of this study was to develop an infection inhibiting urinary catheter for prolonged use. Methods were established to add chlorhexidine digluconate (CHG) to a silicone elastomer and to compression mold the material to form a urinary catheter. CHG was randomly dispersed in the elastomer to be released through elution. Samples of the material, with CHG concentrations ranging from 1 to 4% by weight, were tested for in vitro release characteristics over a 28 day period and for in vivo toxicity over a 7 day period. Release profiles followed a common pattern for each concentration: an initial peak during the first 24 hours was followed by a subsequent decline. CHG amounts released into the saline medium were directly related to the CHG concentration of the samples; 4% samples released the largest amounts and 1% samples released the least amounts. Both 3% and 4% CHG by weight samples released measurable amounts of CHG throughout the entire observation period, whereas 1% CHG by weight samples were depleted after 9 days, and 2% CHG by weight samples were depleted after 19 days. No samples were found to be toxic during in vivo evaluations. These studies suggest that CHG bearing silicone rubber urinary catheters could resist surface colonization and infection for extended periods without toxicity.