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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 because the information has not been verified recently.
Verified September 2005 by Rigshospitalet, Denmark.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT00192985
First received: September 12, 2005
Last updated: September 16, 2005
Last verified: September 2005
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Prevention

Resource links provided by NLM:

U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Rigshospitalet, Denmark

Additional 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
Study First Received: September 12, 2005
Last Updated: September 16, 2005
Health Authority: Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Urinary Tract Infections
Wounds and Injuries
Infection
Urologic Diseases

ClinicalTrials.gov processed this record on May 16, 2013