Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization
Noble Metal Alloy Coated Versus Silicone Foley Catheter in Patients With Long Term Catheterization: A Prospective Randomized Controlled Study
1 other identifier
interventional
100
1 country
1
Brief Summary
Eighty percent of nosocomial UTI caused by indwelling urinary catheters and so known-as catheter-associated UTI. CAUTI leads to multiple local and systemic derangements such as suprapubic pain, dysuria, cystitis, pyelonephritis, septicemia, and even septic shock. This study will be conducted up on 100 patients (50 per each group) with long term catheterization to assess efficacy of noble metal alloy coated catheter in reducing CAUTI.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 21, 2020
CompletedFirst Submitted
Initial submission to the registry
March 28, 2021
CompletedFirst Posted
Study publicly available on registry
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 21, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 21, 2021
CompletedApril 8, 2021
April 1, 2021
1 year
March 28, 2021
April 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Urinary tract infection
incidence of culture documented symotomatic urinary tract infection
14 days
Secondary Outcomes (1)
Catheter tolerance
14 days
Study Arms (2)
Bactiguard urethral catheter
ACTIVE COMPARATORGroup A: Fifty Patients with urethral catheter using noble metal alloy coated catheter (Bactiguard AB, Stockholm ,Sweden).
Silicone Foley urethral catheter
ACTIVE COMPARATORGroup B: Fifty Patients with urethral catheter using silicone Foley catheter (Well Lead, Guangzhou, China).
Interventions
All Patients will have urethral catheterization with either Noble Metal Alloy coated catheter or Silicon Foley catheter.
Eligibility Criteria
You may qualify if:
- \- Patient under age of 80 years old who need prolonged urethral catheterization (more than 2 weeks) as a method of bladder drainage.
You may not qualify if:
- Patients with current or recent symptomatic urinary tract infection.
- Known hypersensitivity to latex, silver salts or hydrogel.
- Patients with recent surgical intervention in the urinary tract.
- Patients with anatomic or functional upper urinary tract issues (e.g reflux, stones, etc.)
- Uncontrolled DM. Patients on corticosteroid treatment. Immunosuppressed patients. Patients received pelvic irradiation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandria University Hospitals
Alexandria, 21646, Egypt
Related Publications (1)
Aljohi AA, Hassan HE, Gupta RK. The efficacy of noble metal alloy urinary catheters in reducing catheter-associated urinary tract infection. Urol Ann. 2016 Oct-Dec;8(4):423-429. doi: 10.4103/0974-7796.192099.
PMID: 28057985BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 28, 2021
First Posted
April 1, 2021
Study Start
May 21, 2020
Primary Completion
May 21, 2021
Study Completion
June 21, 2021
Last Updated
April 8, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share