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Completed

NCT Number: NCT01054690

Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)

This study is a single blinded (Outcome Assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. Patients requiring urinary catheterization will be randomized into two groups and receive either the silver alloyed catheter (test) or a silicone catheter (control).

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Key information

Conditions

Urinary Tract Infection Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Male Urogenital Diseases Urinary Tract Infections Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ortopedkliniken, Hässleholms Sjukhus, Hässleholm, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults in elective surgery requiring urinary catheterization

Exclusion criteria

  • Patients who has or recently (within 3 weeks) had a urinary catheter
  • Signs of urinary tracts infection
  • Previous radiation therapy in lower pelvis
  • Latex allergy
  • Cognitive impaired
  • Do not understand Swedish language.

Treatment and study plan

Bactiguard Infection Protection (BIP) Cathter.

Device

Silicone Urinary Catheter

Device

Primary outcomes

  1. To determine whether a silver alloyed catheter with antibacterial properties will decrease the incidence of catheter associated urinary tract infection in patients undergoing elective surgery.

    Time frame: At catheter withdrawal (normally 1-3 days after catheter insertion).

Secondary outcomes

  1. Patient´s evaluation of the catheterization and overall satisfaction.

    Time frame: At catheter withdrawal and 7-10 days after catheter withdrawal.

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Bactiguard AB, Sweden

Registry information

Official study title

A Comparative Study to Investigate if Silver Alloyed Urinary Catheters Can Reduce the Incidence of Catheter Acquired Urinary Tract Infections in Patients Undergoing Elective Surgery

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 22, 2010
Registry last updated
Jan 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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