Status:
TERMINATED
Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients
Lead Sponsor:
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Collaborating Sponsors:
Asociacion Colaboracion Cochrane Iberoamericana
European Clinical Research Infrastructure Network
Conditions:
Urinary Tract Infection
Eligibility:
All Genders
18+ years
Phase:
NA
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 inj...
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 inju...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
489 Patients enrolled
Trial Details
Trial ID
NCT01803919
Start Date
November 1 2012
End Date
January 1 2016
Last Update
September 20 2016
Active Locations (20)
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1
Mutual de la Seguridad Chilena
Santiago, Chile, 4848
2
Azienda Ospedaliero-Universitaria - Ospedali Riuniti di Ancona - Unità Spinale
Ancona, Italy
3
Azienda Ospedaliero-Universitaria Policlinico di Bari- Unità Operativa di Medicina Fisica e Riabilitazione e Unità Spinale Unipolare
Bari, Italy, 70124
4
Unità Operative Recupero e Riabilitazione Funzionale e Gravi Cerebrolesioni Acquisite
Ceglie Messapica, Italy, 72013