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

NCT ID: NCT00482547

Last Updated: 2017-02-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

1188 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2008-08-31

Brief Summary

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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

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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

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Catheterization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Silver-coated catheter

Bard Hydrogel Silver Salts Coated Latex Urinary Catheter System

Group Type EXPERIMENTAL

Hydrogel Silver Salts Coated Latex Urinary Catheter System

Intervention Type DEVICE

Silver-coated catheter

Silicone-coated catheter

Bard silicone elastomer coated latex catheter system

Group Type PLACEBO_COMPARATOR

Bard silicone elastomer coated latex catheter system

Intervention Type DEVICE

Silicone-coated catheter

Interventions

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Hydrogel Silver Salts Coated Latex Urinary Catheter System

Silver-coated catheter

Intervention Type DEVICE

Bard silicone elastomer coated latex catheter system

Silicone-coated catheter

Intervention Type DEVICE

Other Intervention Names

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AgSC arm SiCS arm

Eligibility Criteria

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Inclusion Criteria

* male or female at least 18 years of age
* life expectancy of 3 months or more
* expected to require a urinary catheter for at least 48 hours

Exclusion Criteria

* recent urinary tract surgery or instrumentation
* presence of a urinary tract device
* concurrent genitourinary tract infection
* recent indwelling urinary catheter
* requires use of a non-study urinary catheter
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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C. R. Bard

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mark Rupp, MD

Role: PRINCIPAL_INVESTIGATOR

University of Nebraska

Locations

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Henry Ford Hospital

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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BMD-6003

Identifier Type: -

Identifier Source: org_study_id

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