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Does a Nitrofurazone Coated Bladder Catheter Reduce the Number of Urinary Tract Infections in Trauma

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ClinicalTrials.gov Identifier: NCT00192985
Recruitment Status : Unknown
Verified September 2005 by Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
First Posted : September 19, 2005
Last Update Posted : September 19, 2005
Sponsor:
Information provided by:
Rigshospitalet, Denmark

Brief Summary:
Urinary tract infections occurs in trauma. We investigate whether a nitrofurazone coated can reduce the number of urinary tract infections.

Condition or disease Intervention/treatment Phase
Trauma Urinary Tract Infections Device: Nitrofuranzone coated bladder catheter Phase 3

Detailed Description:
Urinary tract infection occurs in one in five patients as a complication following severe trauma. A new and approved urinary bladder catheter (Releen NF) has been introduced by the Danish company Coloplast A/S. Releen NF is expected to reduce the number of urinary tract infections, but this effect has not been investigated in trauma patients.

Study Type : Interventional  (Clinical Trial)
Enrollment : 216 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention
Study Start Date : May 2003
Study Completion Date : September 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. urinary tract infections

Secondary Outcome Measures :
  1. length of stay


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical suspicion of multiple trauma
  • Age >/= 18 years
  • Direct referral from scene of accident
  • Indication for urinary bladder catherization

Exclusion Criteria:

  • Major burn injury
  • HIV positiv
  • Pregnancy

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00192985


Locations
Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark, DK-2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Study Chair: Jakob Stensballe, MD Rigshospitalet, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00192985     History of Changes
Other Study ID Numbers: KF 01-160/02 Catheter
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: September 19, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Infection
Urinary Tract Infections
Urologic Diseases