Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01054690
Other study ID # H15 315/2007
Secondary ID
Status Completed
Phase N/A
First received January 14, 2010
Last updated January 20, 2010
Start date October 2008
Est. completion date August 2009

Study information

Verified date January 2010
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority Sweden: The National Board of Health and Welfare
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 511
Est. completion date August 2009
Est. primary completion date August 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention


Intervention

Device:
Bactiguard Infection Protection (BIP) Cathter.

Silicone Urinary Catheter


Locations

Country Name City State
Sweden Ortopedkliniken, Hässleholms Sjukhus Hässleholm
Sweden Ortopedklinien, Lunds Hospital Lund
Sweden Ortopedkliniken Lasarettet i Trelleborg Trelleborg

Sponsors (2)

Lead Sponsor Collaborator
Region Skane Bactiguard AB, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). Yes
Secondary Patient´s evaluation of the catheterization and overall satisfaction. At catheter withdrawal and 7-10 days after catheter withdrawal. Yes
See also
  Status Clinical Trial Phase
Completed NCT03235947 - Perioperative Fosfomycin in the Prophylaxis of Urinary Tract Infection in Kidney Transplant Recipients Phase 4
Withdrawn NCT01881165 - Cranberry on Urinary Tract Infections Phase 4
Terminated NCT02198833 - Efficacy of Micro-Patterned Foley Catheter to Reduce Catheter-Associated Urinary Tract Infection N/A
Completed NCT01687114 - Urinary Proanthocyanidin-A2 as a Biomarker of Compliance to Intake of Cranberry Products N/A
Completed NCT02357758 - Effects of Antibiotic Prophylaxis on Recurrent UTI in Children Phase 4
Completed NCT01391793 - Corticosteroids for Children With Febrile Urinary Tract Infections Phase 3
Completed NCT01219595 - Cranberry Proanthocyanidins for Modification of Intestinal E. Coli Flora and Prevention of Urinary Tract Infections in UTI-Susceptible Women N/A
Completed NCT00365430 - SAFE or SORRY? Patient Safety Study of the Prevention of Adverse Patient Outcomes N/A
Recruiting NCT04502095 - Prophylactic Antibiotics for Urinary Tract Infections After Robot-Assisted Radical Cystectomy Phase 4
Completed NCT00976963 - Single Dose Monurol for Treatment of Acute Cystitis N/A
Recruiting NCT02568800 - Prolonged Infusion Cefepime and Nosocomial Infections Phase 3
Completed NCT02785445 - Healthy.io Method Comparison & User Performance Study N/A
Completed NCT02216253 - L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract to Prevent Postoperative Urinary Tract Infection. N/A
Completed NCT01478620 - Safety and Efficacy of Canephron® N in the Management of Uncomplicated Urinary Tract Infections (uUTI) Phase 3
Completed NCT00371631 - Colonizing Neurogenic Bladders With Benign Flora Phase 1
Terminated NCT03697993 - Safety and Efficacy Study of Oral Fosfomycin Versus Oral Levofloxacin to Treat Complicated Urinary Syndromes (FOCUS) Phase 4
Terminated NCT01803919 - Efficacy Study of Antimicrobial Catheters to Avoid Urinary Infections in Spinal Cord Injured Patients N/A
Enrolling by invitation NCT01231737 - Efficacy of Two Prophylactic Schedules (Prulifloxacin Versus Phosphomycin) Phase 2
Completed NCT01763008 - A Study of the Safety and Effectiveness of Doripenem in Filipino Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections Phase 4
Completed NCT00528476 - Risk Factors for Recurrent Urinary Tract Infection in Children N/A