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Clinical Trials/NCT00192985
NCT00192985UnknownPhase 3

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

Rigshospitalet, Denmark2 sites in 1 country216 target enrollmentStarted: May 2003Last updated:
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Conditions

Trial Snapshot

Phase
Phase 3
Enrollment
216
Locations
2
Primary Endpoint
urinary tract infections
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
Single

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Outcomes

Primary Outcomes

urinary tract infections

Secondary Outcomes

  • length of stay

Investigators

Sponsor Class
Other

Study Sites (2)

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