Silver Alloyed Urinary Catheters and Incidence of Cathete... | NCT01054690

Studies
Silver Alloyed Urinary Catheters and Incidence of Catheter Acquired Urinary Tract Infections (UTI)

NCT01054690

Sponsor

Region Skane

Status

Completed

Last Update Posted

Jan 22, 2010Estimated

Enrollment

511Actual

Phase

Not Applicable

Conditions

Urinary Tract Infection

Interventions

Bactiguard Infection Protection (BIP) Cathter.
Silicone Urinary Catheter

Countries

Sweden

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

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Aug 2009Actual

Completion Date

Aug 2009Actual

First Submitted Date

Jan 14, 2010

First Submission Date that Met QC Criteria

Jan 20, 2010

First Posted Date

Jan 22, 2010Estimated

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

Jan 20, 2010

Last Update Posted Date

Jan 22, 2010Estimated

Name	Class
Bactiguard AB, Sweden	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a single blinded (Outcome Assessors), multicenter randomized controlled study designed to investigate if a silver alloyed urinary catheter with antibacterial properties can reduce the incidence of catheter acquired urinary tract infections in patients undergoing elective surgery. Patients requiring urinary catheterization will be randomized into two groups and receive either the silver alloyed catheter (test) or a silicone catheter (control).

Detailed Description

Not provided

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

511Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Silver alloyed urinary catheter	Experimental		Device: Bactiguard Infection Protection (BIP) Cathter.
Silicone urinary catheter	Placebo Comparator		Device: Silicone Urinary Catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Bactiguard Infection Protection (BIP) Cathter.	Device		Silver alloyed urinary catheter
Silicone Urinary Catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To determine whether a silver alloyed catheter with antibacterial properties will decrease the incidence of catheter associated urinary tract infection in patients undergoing elective surgery.		At catheter withdrawal (normally 1-3 days after catheter insertion).

Secondary Outcomes

Measure	Description	Time Frame
Patient´s evaluation of the catheterization and overall satisfaction.		At catheter withdrawal and 7-10 days after catheter withdrawal.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adults in elective surgery requiring urinary catheterization

Exclusion Criteria:

Patients who has or recently (within 3 weeks) had a urinary catheter
Signs of urinary tracts infection
Previous radiation therapy in lower pelvis
Latex allergy
Cognitive impaired
Do not understand Swedish language.

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
Karin Stenzelius, PhD Nurse	Department Urology, University Hospital in Lund, Sweden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ortopedkliniken, Hässleholms Sjukhus		Hässleholm		281 25	Sweden
Ortopedklinien, Lunds Hospital

Condition Browse Module

MeSH Terms

ID	Term
D014552	Urinary Tract Infections

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided