Clinical Trials Directory

Trials / Terminated

TerminatedNCT00482547

Study of a Urethral Catheter Coated With Eluting Silver Salts (SUCCESS)

Study of a Urethral Catheter Coated With Eluting Silver Salts

Status
Terminated
Phase
Phase 4
Study type
Interventional
Enrollment
1,188 (actual)
Sponsor
C. R. Bard · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

Urinary catheters are often needed in hospital patients, but their use can increase the chance that a catheter associated urinary tract infection (called a CAUTI) may occur. This study will try to determine if patients who get a new silver coated catheter will have slower to time to development of a CAUTI compared to patients who get an uncoated catheter.

Detailed description

This study is a prospective, multicenter, randomized controlled pivotal study designed to compare the time to occurrence and incidence of CAUTI in subjects catheterized with a new hydrogel-silver salts latex catheter (test) to those of subjects catheterized with a silicone elastomer-coated latex catheter (control).

Conditions

Interventions

TypeNameDescription
DEVICEHydrogel Silver Salts Coated Latex Urinary Catheter SystemSilver-coated catheter
DEVICEBard silicone elastomer coated latex catheter systemSilicone-coated catheter

Timeline

Start date
2007-06-01
Primary completion
2008-04-01
Completion
2008-08-01
First posted
2007-06-05
Last updated
2017-02-28
Results posted
2010-01-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00482547. Inclusion in this directory is not an endorsement.