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

NCT01803919 | Terminated DMC

• 2 other identifiers: IIBSP-SUR-2011-68112210
• Study Type: interventional
• Target: 489
• Locations: 5 countries
• Sites: 20

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.

Conditions

Urinary Tract Infection

Keywords

Spinal cord injuries; Urinary tract infection; Urinary catheters; Protocol; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Incidence of catheter associated urinary tract infection

  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).

  at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)

Secondary Outcomes (2)

• Asymptomatic urinary tract infection

  at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)

• Bacteremic urinary tract infection

  at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)

Other Outcomes (2)

• Direct costs

  From catheterization procedure and 30th day, catheter removal or catheter replacement or finalization of complication(s) or related treatment(s), whichever last longer.

• Number of participants with adverse events related to catheterization as a Measure of Safety and Tolerability

  at any time from catheterization procedure and 30th day, catheter removal or catheter replacement (whichever occurs first)

Study Arms (2)

Silver Alloy-Coated Urinary Catheters

EXPERIMENTAL

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.

Device: Silver Alloy-Coated Urinary Catheters

Conventional Urinary Catheter

OTHER

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.

Device: Conventional Urinary Catheter

Interventions

Silver Alloy-Coated Urinary Catheters DEVICE

Also known as: BIP Foley catheter - Silicone Bactiguard Infection Protection

Silver Alloy-Coated Urinary Catheters

Conventional Urinary Catheter DEVICE

Also known as: 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)

Conventional Urinary Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage, reflex voiding or use of an external collector.
• 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.

Sponsors & Collaborators

• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: lead
• Asociacion Colaboracion Cochrane Iberoamericana: collaborator
• European Clinical Research Infrastructure Network: collaborator

Study Sites (20)

Mutual de la Seguridad Chilena

Santiago, 4848, Chile

Location

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

Ancona, Italy

Location

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

Bari, 70124, Italy

Location

Unità Operative Recupero e Riabilitazione Funzionale e Gravi Cerebrolesioni Acquisite

Ceglie Messapica, 72013, Italy

Location

Unità Spinale Unipolare

Rome, 00142, Italy

Location

Centro de Medicina de Reabilitação de Alcoitão

Alcoitão, Alcabideche, 2649-506, Portugal

Location

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

Braga, 4710-243, Portugal

Location

Centro Hospitalar do Porto

Porto, 4099-001, Portugal

Location

Complexo Hospitalario Universitario A Coruña

A Coruña, A Coruña, Spain

Location

Hospital de Neurorrehabilitación Instituto Guttmann

Badalona, Barcelona, Spain

Location

Hospital Universitario Puerta del Mar

Cadiz, Cadiz, Spain

Location

Complejo Hospitalario Universitario Insular - Materno Infantil de Canarias

Las Palmas de Gran Canaria, Las Palmas, Spain

Location

Hospital Universitario La Paz

Madrid, Madrid, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital Universitario Virgen del Rocío

Seville, Sevilla, Spain

Location

Hospital Nacional de Parapléjicos

Toledo, Toledo, Spain

Location

Hospital Universitario Cruces

Barakaldo, Vizcaya, Spain

Location

Hospital Universitario Miguel Servet

Zaragoza, Zaragoza, Spain

Location

Dokuz Eylul University Dept. of Physical Medicine and Rehabilitation

Alsancak, İzmir, 35210, Turkey (Türkiye)

Location

Ege University Dept. of Physical Medicine and Rehabilitation

Bornova, İzmir, 35040, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 23895463 BACKGROUND

MeSH Terms

Conditions

Urinary Tract Infections; Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Xavier Bonfill, MD, PhD

  Asociacion Colaboracion Cochrane Iberoamericana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2013
• First Posted: March 4, 2013
• Study Start: November 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

CL (1); TU (2); IT (4); ES (10); PT (3)