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NCT00192985 Clinical Trial

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

Trauma Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00192985
Other study ID # KF 01-160/02 Catheter
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received September 12, 2005
Last updated September 16, 2005
Start date May 2003
Est. completion date September 2006

Study information
Verified date September 2005
Source Rigshospitalet, Denmark
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Interventional

Clinical Trial Summary

Urinary tract infections occurs in trauma. We investigate whether a nitrofurazone coated can reduce the number of urinary tract infections.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 216
Est. completion date September 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Device:
• Nitrofuranzone coated bladder catheter

Locations
Country Name City State
Denmark Rigshospitalet, Copenhagen University Hospital Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary urinary tract infections
Secondary length of stay
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