Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients (ESCALE)

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Status: Terminated

Conditions: Urinary Tract Infection

Treatments: Device: Conventional Urinary Catheter; Device: Silver Alloy-Coated Urinary Catheters

Study type: Interventional

Funder types: Other

Identifiers

NCT01803919

112210 (Other Grant/Funding Number)

IIBSP-SUR-2011-68

Details and patient eligibility

About

The purpose of this trial is to make a comparison between the use of antiseptic silver alloy-coated silicone urinary catheters and the use of conventional silicone urinary catheters in spinal cord injured patients to prevent urinary infections.

Full description

Antiseptic Silver Alloy-Coated Silicone Urinary Catheters seems to be a promising intervention to reduce urinary tract infections; however, research evidence cannot be extrapolated to spinal cord injured patients.

The study is an open, randomized, multicentric, and parallel clinical trial with blinded assessment. The study includes spinal cord injured patients who require at least seven days of urethral catheterization as a method of bladder voiding. Participants are on-line centrally randomized and allocated to one of the two interventions (Antiseptic Urinary Catheters or Conventional Catheters). Catheters are used for a maximum period of 30 days or removed earlier at the clinician criteria.

The main outcome is the incidence of urinary tract infections by the time of catheter removal or at day 30 after catheterization, the event that occurs first. Intention-to-treat analysis will be performed, as well as a primary analysis of all patients.

The aim of this study is to assess whether silver alloy-coated silicone urinary catheters reduce urinary infections in spinal cord injured patients.

Enrollment: 489 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients with traumatic or medical spinal cord injury
• Age of 18 years or above
• Patients who need an indwelling urinary catheter as a method of bladder drainage for at least 7 days.
• Patients who are willing to participate in the study and give their written informed consent (If a patient is unable to give written consent because of physical or mental disability, an affirmation of consent will be taken in his presence from his relative or legal guardian).

Exclusion criteria

• Patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage, reflex voiding or use of an external collector.
• Patients with urinary tract infection at the moment of inclusion
• Current antibiotic use or use within 7 days prior to inclusion
• Outpatients with sporadic medical examinations (less than one per month)
• Known allergy to latex, silver salts or hydrogels.
• Patients with surgical interventions in the urinary tract that may interfere, at the investigator criteria, with the study results.
• Pregnant or breastfeeding woman.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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489 participants in 2 patient groups

Silver Alloy-Coated Urinary Catheters

Experimental group

Description:

Bactiguard® Infection Protection coating consists of noble metals such as gold, palladium and silver. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study.

Treatment:

Device: Silver Alloy-Coated Urinary Catheters

Conventional Urinary Catheter

Other group

Description:

Conventional or standard urinary catheters are those commonly used in each study center, most of them made of silicone or silicone-latex. Trained health staff performs urethral catheterization and select the most adequate catheter size. To ensure aseptic conditions they are asked to strictly follow the current protocol in their respective centers. Indwelling urethral catheters are periodically replaced about 30 days of use; to not interfere with current clinical practice, the policy of each center (or the investigator criteria) for catheter replacement and removal is considered valid for this study.

Treatment:

Device: Conventional Urinary Catheter