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

Phase 3

• Conditions: Urinary Tract Infections; Trauma

• Registration Number: NCT00192985
• Lead Sponsor: Rigshospitalet, Denmark

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.

Study Timeline

• Study Start: 2003-05
• Status Verified: 2005-09
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-16
• Last Update Submitted: 2005-09-16
• Study First Posted: 2005-09-19
• Last Update Posted: 2005-09-19
• Study Completion: 2006-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 216

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
urinary tract infections

Secondary Outcome Measures

Name	Time	Method
length of stay

Trial Locations

Locations (1)

Rigshospitalet, Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark