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

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00192985
Enrollment
216
Registered
2005-09-19
Start date
2003-05-31
Completion date
2006-09-30
Last updated
2005-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trauma, Urinary Tract Infections

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.

Interventions

DEVICENitrofuranzone coated bladder catheter

Sponsors

Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
urinary tract infections

Secondary

MeasureTime frame
length of stay

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 6, 2026