Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic) Clinical Trial
Official title:
Prospective Cohort Study on the Tolerability and Safety of Uro-Tainer® Polihexanide 0.02% in Long-term Indwelling Catheterized Patients.
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.
The objective of this study is to assess the tolerability and safety of Uro-Tainer®
Polihexadine 0.02% intended as routine rinsing and bacterial decolonization of urinary
catheters in long-term catheterized patients. After each instillation patients will be
assessed for vital signs, skin reactions and other symptoms suggesting intolerance or
sensitivity and/or allergic reaction. In addition, pain will be assessed in the first 5
patients and any other patients with sustained pain sensation in the bladder.
Catheters will be rinsed by gravity feed with 100ml solution of UT-P 0.02% once a day for a
maximum of 5 instillations. A minimum interval of 24 hours must be guaranteed for the
enrolment of the first 5 patients and their first irrigation with the investigational
product.
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