NCT02157415

Prospective Cohort Study on Tolerability & Safety of Uro-Tainer® Polihexanide 0.02%

Prospective Cohort Study on the Tolerability and Safety of Uro-Tainer® Polihexanide 0.02% in Long-term Indwelling Catheterized Patients.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: B. Braun Ltd. Centre of Excellence Infection Control · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Complications; Catheter, Urinary (Indwelling Catheter) (Suprapubic)

Interventions

Type	Name	Description
DEVICE	Uro-Tainer Polihexanide 0.02%	Catheters will be rinsed by gravity feed with 100ml solution of UT-P 0.02% once a day for a maximum of 5 instillations.

Timeline

• Start date: 2013-08-01
• Primary completion: 2018-07-01
• Completion: 2018-07-01
• First posted: 2014-06-06
• Last updated: 2018-08-02

Locations

5 sites across 3 countries: Belgium, Germany, Switzerland