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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2005 by Rigshospitalet, Denmark.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00192985
First Posted: September 19, 2005
Last Update Posted: December 9, 2005
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.
Information provided by:
Rigshospitalet, Denmark
  Purpose
Urinary tract infections occurs in trauma. We investigate whether a nitrofurazone coated can reduce the number of urinary tract infections.

Condition Intervention Phase
Trauma Urinary Tract Infections Device: Nitrofuranzone coated bladder catheter Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • urinary tract infections

Secondary Outcome Measures:
  • length of stay

Estimated Enrollment: 216
Study Start Date: May 2003
Estimated Study Completion Date: September 2006
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.
  Eligibility

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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
  Contacts and Locations
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 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
  More Information

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 Submitted: September 12, 2005
First Posted: September 19, 2005
Last Update Posted: December 9, 2005
Last Verified: September 2005

Additional relevant MeSH terms:
Infection
Urinary Tract Infections
Urologic Diseases