This trial is active, not recruiting.

Conditions trauma, urinary tract infections
Treatment nitrofuranzone coated bladder catheter
Phase phase 3
Sponsor Rigshospitalet, Denmark
Start date May 2003
End date September 2006
Trial size 216 participants
Trial identifier NCT00192985, KF 01-160/02 Catheter


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking single blind
Primary purpose prevention

Primary Outcomes

urinary tract infections
time frame:

Secondary Outcomes

length of stay
time frame:

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2005.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.