The phase I effort on the testing and performance of a biocidal device (Foley Guard) placed between the catheters and urinary leg bags to prevent ascending infections from leg bags into the urinary catheters was successfully completed. An in vitro apparatus mimicking a catheterized bladder with infected leg bags was used. A multi channel pump and manifolds allowed comparison between the controls and the experimental devices under the same conditions. The addition of a biocidal device as an accessory to the leg bags resulted in the complete absence of any microorganisms near the catheter base for over 10-14 days, which was the duration of the experiment. All of the corresponding controls showed high levels of the bacteria near the catheter base within 3-9 days. These in vitro tests suggest a useful role for the device in controlling infection in patients undergoing short and long term indwelling catheterization. A continuous challenge of three pathogens in human urine medium, showed that for up to 30 days the materials inhibited all the bacteria completely. The broad-spectrum activities of the phase I biocidal material used in this Foley guard has been well established by the PI. (toward bacteria, mold, and candida-type yeast species). A two week rabbit- muscle implantation study of the biocidal material resulted in a non-toxic response. The phase II will optimize the formulation and the manufacturing protocols. A series of microbiological tests using the strains from catheterized patients will be performed to assess: the biocidal potency per unit weight of the material, the potency before and after extensive washing in synthetic urine and the bactericidal activity and the longevity of the device under in vitro conditions. The biocide release concentrations will be established firmly for our claims. Finally, human clinical trials will be conducted to establish the efficacy and performance and compared to controls.
In 1992 the number of urogenital devices in North America was substantial. About 1.6 billion incontinence pads and devices, 16 million catheters and 58 billion diapers were reportedly used. (Reid, 1994 J. of industrial microbiology, 13 90-96) Estimates of the cost of treating catheter-related UTI have ranged as high as $39,960 per patient per year including the increase in nursing care required. As the senior population grows this problem is becoming more common. We believe if our accessories are used by 20% of the leg bag users, a market at least million accessories exists.
| Leuck, Anne-Marie; Johnson, James R; Hunt, Matthew A et al. (2015) Safety and efficacy of a novel silver-impregnated urinary catheter system for preventing catheter-associated bacteriuria: a pilot randomized clinical trial. Am J Infect Control 43:260-5 |
