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

NCT02157415 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2018-08-02

No results posted yet for this study

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.

Conditions

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

Interventions

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.

Sponsors & Collaborators

  • B. Braun Ltd. Centre of Excellence Infection Control

    lead INDUSTRY

Principal Investigators

  • Jürgen Pannek, Prof. · Schweizer Paraplegikerzentrum Nottwil

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2018-07-31
Completion
2018-07-31

Countries

  • Belgium
  • Germany
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02157415 on ClinicalTrials.gov