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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
Information provided by:
Rigshospitalet, Denmark Identifier:
First received: September 12, 2005
Last updated: September 16, 2005
Last verified: September 2005
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.

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
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Please refer to this study by its identifier: NCT00192985

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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00192985     History of Changes
Other Study ID Numbers: KF 01-160/02 Catheter
Study First Received: September 12, 2005
Last Updated: September 16, 2005

Additional relevant MeSH terms:
Urinary Tract Infections
Urologic Diseases processed this record on September 21, 2017