Urinary Infections Clinical Trial
Official title:
Prevention of Catheter Associated Lower Urinary Infections Using the Oxys Indwelling Catheter
The safety and efficacy of a urinary catheter designed to prevent catheter associated urinary infections is studied.
This study is an open randomized controlled trial of 4 weeks duration. The intervention is a
novel urinary catheter with an electromagnetic therapy to prevent catheter associated
infections. The catheter is used in patients which require longterm urinary catheterization
over at least 1 month.
The endpoint is bacteriological exam and the laboratory is blinded to the therapy status.
Weekly urinary cultures are drawn and a sonication culture of the catheter tip is performed
to detect and characterize the biofilm. A colonization rate of >95% is anticipated in the
control arm. Therefore a 50% reduction in colonization can be detected with 54 patients, a
90% reduction in colonization can be detected with 20 patients with a power of 0.9.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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