Stopped: After consultation with a medical expert the Notified Body confirmed premature termination of the study.
It is the first clinical study aimed at assessing the safety and tolerability of UT-P as routine rinsing and bacterial decolonization solution device for urinary catheters. The study will be conducted in hospitalized adult patients who had an urethral or suprapubic catheter in place for longer than two consecutive weeks and who are able to provide written consent. This is an open-label prospective observational cohort study. No comparative control group is planned as no other preventing infection solution is commercially available at this time.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
to assess the tolerability of Uro-Tainer® Polihexanide 0.02%
Timeframe: Day 1, Day 2, Day 3, Day 4, Day 5