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

• Sponsor: Region Skane (Other)
• Overall Status: Completed
• CT.gov ID: NCT01054690
• Collaborator: Bactiguard AB, Sweden (Other)
• Enrollment: 511
• Locations: 3
• Arms: 2
• Duration (Months): 10
• Patients Per Site: 170.3
• Patients Per Site Per Month: 17.1

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Urinary Tract Infection	Device: Bactiguard Infection Protection (BIP) Cathter.; Device: Silicone Urinary Catheter	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 511 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Comparative Study to Investigate if Silver Alloyed Urinary Catheters Can Reduce the Incidence of Catheter Acquired Urinary Tract Infections in Patients Undergoing Elective Surgery
• Study Start Date: Oct 1, 2008
• Actual Primary Completion Date: Aug 1, 2009
• Actual Study Completion Date: Aug 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Silver alloyed urinary catheter	Device: Bactiguard Infection Protection (BIP) Cathter.
Placebo Comparator: Silicone urinary catheter	Device: Silicone Urinary Catheter

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Patient´s evaluation of the catheterization and overall satisfaction. [At catheter withdrawal and 7-10 days after catheter withdrawal.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ortopedkliniken, Hässleholms Sjukhus	Hässleholm		Sweden	281 25
2	Ortopedklinien, Lunds Hospital	Lund		Sweden	221 85
3	Ortopedkliniken Lasarettet i Trelleborg	Trelleborg		Sweden	231 52

Sponsors and Collaborators

• Region Skane
• Bactiguard AB, Sweden

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT01054690
• Other Study ID Numbers: H15 315/2007
• First Posted: Jan 22, 2010
• Last Update Posted: Jan 22, 2010
• Last Verified: Jan 1, 2010

• Keywords provided by , ,: Catheterization; Urinary Tract Infection; Elective Surgery
• Additional relevant MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections

Study Results

No Results Posted as of Jan 22, 2010