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

NCT ID: NCT01803919

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 489 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-01-31

Brief Summary

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.

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.

Conditions

Urinary Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Silver Alloy-Coated Urinary Catheters

Intervention Type: DEVICE

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.

Group Type: OTHER

Conventional Urinary Catheter

Intervention Type: DEVICE

Interventions

Silver Alloy-Coated Urinary Catheters

Intervention Type: DEVICE

Conventional Urinary Catheter

Intervention Type: DEVICE

Other Intervention Names

BIP Foley catheter - Silicone Bactiguard Infection Protection; Foley silicona 100% (16 or 18 Ch); Foley Rüsch (16 or 18 Ch); Foley Bardex (16 or 18 Ch); Folysil (16 or 18 Ch); Foley Rochester (16 or 18 Ch); Foley Euromedical (16 or 18 Ch)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Asociacion Colaboracion Cochrane Iberoamericana

OTHER

Sponsor Role: collaborator

European Clinical Research Infrastructure Network

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xavier Bonfill, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Asociacion Colaboracion Cochrane Iberoamericana

Locations

Mutual de la Seguridad Chilena

Santiago, , Chile

Azienda Ospedaliero-Universitaria - Ospedali Riuniti di Ancona - Unità Spinale

Ancona, , Italy

Azienda Ospedaliero-Universitaria Policlinico di Bari- Unità Operativa di Medicina Fisica e Riabilitazione e Unità Spinale Unipolare

Bari, , Italy

Unità Operative Recupero e Riabilitazione Funzionale e Gravi Cerebrolesioni Acquisite

Ceglie Messapica, , Italy

Unità Spinale Unipolare

Rome, , Italy

Centro de Medicina de Reabilitação de Alcoitão

Alcoitão, Alcabideche, Portugal

Centro Clínico Académico - Braga, Associação (2CA-Braga)

Braga, , Portugal

Centro Hospitalar do Porto

Porto, , Portugal

Complexo Hospitalario Universitario A Coruña

A Coruña, A Coruña, Spain

Hospital de Neurorrehabilitación Instituto Guttmann

Badalona, Barcelona, Spain

Hospital Universitario Puerta del Mar

Cadiz, Cadiz, Spain

Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias

Las Palmas de Gran Canaria, Las Palmas, Spain

Hospital Universitario La Paz

Madrid, Madrid, Spain

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Hospital Nacional de Parapléjicos

Toledo, Toledo, Spain

Hospital Universitario Cruces

Barakaldo, Vizcaya, Spain

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, Spain

Dokuz Eylul University Dept. of Physical Medicine and Rehabilitation

Alsancak, İzmir, Turkey (Türkiye)

Ege University Dept. of Physical Medicine and Rehabilitation

Bornova, İzmir, Turkey (Türkiye)

Countries

Chile; Italy; Portugal; Spain; Turkey (Türkiye)

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.

Reference Type: BACKGROUND

PMID: 23895463 (View on PubMed)

Other Identifiers

112210

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IIBSP-SUR-2011-68

Identifier Type: -

Identifier Source: org_study_id