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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
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

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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

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

Publications automatically indexed to this study by Identifier (NCT Number): 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:
Urinary Tract Infections
Urologic Diseases