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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-05-31

Study Completion Date

2006-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Trauma Urinary Tract Infections

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Interventions

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Nitrofuranzone coated bladder catheter

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Jakob Stensballe, MD

Role: STUDY_CHAIR

Rigshospitalet, Denmark

Locations

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Rigshospitalet, Copenhagen University Hospital

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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Stensballe J, Tvede M, Looms D, Lippert FK, Dahl B, Tonnesen E, Rasmussen LS. Infection risk with nitrofurazone-impregnated urinary catheters in trauma patients: a randomized trial. Ann Intern Med. 2007 Sep 4;147(5):285-93. doi: 10.7326/0003-4819-147-5-200709040-00002.

Reference Type DERIVED

PMID: 17785483 (View on PubMed)

Other Identifiers

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KF 01-160/02 Catheter

Identifier Type: -

Identifier Source: org_study_id