Does a Nitrofurazone Coated Bladder Catheter Reduce the N... | NCT00192985

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

NCT00192985

Sponsor

Rigshospitalet, Denmark

Status

Unknown status

Last Update Posted

Sep 19, 2005Estimated

Enrollment

216

Phase

Phase 3

Conditions

Trauma
Urinary Tract Infections

Interventions

Nitrofuranzone coated bladder catheter

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Not provided

Completion Date

Sep 2006

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 16, 2005

First Posted Date

Sep 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2005

Last Update Posted Date

Sep 19, 2005Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

216

Name	Type	Description	Arm Group Labels	Other Names
Nitrofuranzone coated bladder catheter	Device

Measure	Description	Time Frame
urinary tract infections

Measure	Description	Time Frame
length of stay

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jakob Stensballe, MD	Rigshospitalet, Denmark	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet, Copenhagen University Hospital		Copenhagen		DK-2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17785483	Derived	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.

ID	Term
D014947	Wounds and Injuries
D014552	Urinary Tract Infections

ID	Term
D007239	Infections
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications