Back to resultsDoes a Nitrofurazone Coated Bladder Catheter Reduce the Number of Urinary Tract Infections in Trauma
Primary Purpose
Trauma, Urinary Tract Infections
Status
Unknown status
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Nitrofuranzone coated bladder catheter
Sponsored by
About this trial
This is an interventional prevention trial for Trauma
Eligibility 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
Sites / Locations
- Rigshospitalet, Copenhagen University Hospital
Outcomes
Primary Outcome Measures
urinary tract infections
Secondary Outcome Measures
length of stay
Full Information
NCT ID
NCT00192985
First Posted
September 12, 2005
Last Updated
September 16, 2005
Sponsor
Rigshospitalet, Denmark
1. Study Identification
Unique Protocol Identification Number
NCT00192985
Brief Title
Does a Nitrofurazone Coated Bladder Catheter Reduce the Number of Urinary Tract Infections in Trauma
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Unknown status
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2006 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Rigshospitalet, Denmark
4. Oversight
5. Study Description
Brief Summary
Urinary tract infections occurs in trauma. We investigate whether a nitrofurazone coated can reduce the number of urinary tract infections.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trauma, Urinary Tract Infections
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
216 (false)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Nitrofuranzone coated bladder catheter
Primary Outcome Measure Information:
Title
urinary tract infections
Secondary Outcome Measure Information:
Title
length of stay
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jakob Stensballe, MD
Organizational Affiliation
Rigshospitalet, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Rigshospitalet, Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
17785483
Citation
Stensballe J, Tvede M, Looms D, Lippert FK, Dahl B, Tonnesen E, Rasmussen LS. Infection risk with nitrofurazone-impregnated urinary catheters in trauma patients: a randomized trial. Ann Intern Med. 2007 Sep 4;147(5):285-93. doi: 10.7326/0003-4819-147-5-200709040-00002.
Results Reference
derived
Learn more about this trial
Does a Nitrofurazone Coated Bladder Catheter Reduce the Number of Urinary Tract Infections in Trauma
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