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

C. R. Bard

Status and phase: Terminated; Phase 4

Conditions: Catheterization

Treatments: Device: Bard silicone elastomer coated latex catheter system; Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00482547

BMD-6003

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,188 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,188 participants in 2 patient groups, including a placebo group

Silver-coated catheter

Experimental group

Description:

Bard Hydrogel Silver Salts Coated Latex Urinary Catheter System

Treatment:

Device: Hydrogel Silver Salts Coated Latex Urinary Catheter System

Silicone-coated catheter

Placebo Comparator group

Description:

Bard silicone elastomer coated latex catheter system

Treatment:

Device: Bard silicone elastomer coated latex catheter system