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

Overview

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 Title of Study: “Multicentric, Controlled, Randomized Clinical Trial to Assess the Efficacy and Cost-effectiveness of Urinary Catheters With Silver Alloy Coating Versus Conventional Catheters in Spinal Cord Injured Patients”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2015

Detailed 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.

Interventions

  • Device: Silver Alloy-Coated Urinary Catheters
  • Device: Conventional Urinary Catheter

Arms, Groups and Cohorts

  • Experimental: Silver Alloy-Coated Urinary Catheters
    • 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.
  • Other: Conventional Urinary Catheter
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of catheter associated urinary tract infection
    • Time Frame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
    • Is considered that a patient suffer a urinary tract infection if they have at least one suggestive sign or symptom with no other recognized cause and a positive urine culture with no more than 2 species of microorganisms. An urinary tract infection is considered catheter associated if the specimen collection is performed at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first).

Secondary Measures

  • Asymptomatic urinary tract infection
    • Time Frame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
    • A positive urine culture with no more than 2 species of microorganisms(collected at any time from catheterization procedure and 30th day, catheter removal or catheter replacement, whichever occurs first), and no signs or symptoms.
  • Bacteremic urinary tract infection
    • Time Frame: at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)
    • Those with the primary outcome and with a positive blood culture with at least 1 matching uropathogen microorganism to the urine culture.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundació Institut de Recerca de l’Hospital de la Santa Creu i Sant Pau
  • Collaborator
    • Asociacion Colaboracion Cochrane Iberoamericana
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xavier Bonfill, MD, PhD, Principal Investigator, Asociacion Colaboracion Cochrane Iberoamericana

References

Bonfill X, Rigau D, Jauregui-Abrisqueta ML, Barrera Chacon JM, de la Barrera SS, Aleman-Sanchez CM, Bea-Munoz M, Moraleda Perez S, Borau Duran A, Espinosa Quiros JR, Ledesma Romano L, Fuertes ME, Araya I, Martinez-Zapata MJ. A randomized controlled trial to assess the efficacy and cost-effectiveness of urinary catheters with silver alloy coating in spinal cord injured patients: trial protocol. BMC Urol. 2013 Jul 30;13:38. doi: 10.1186/1471-2490-13-38.

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