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Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization

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ClinicalTrials.gov Identifier: NCT04825314
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Tamer Abou Youssif, Alexandria University

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.


Condition or disease Intervention/treatment Phase
Urinary Tract Infections Catheter Infection Catheter-Related Infections Infection Device: Urethral catheter Not Applicable

Detailed Description:

This prospective controlled randomized study conducted upon 100 patients at Alexandria University hospital from 21 May 2020 to 21 December 2020. Patients enrolled will be divided into two equal groups according to the urethral catheter inserted

The institutional ethics committee for research approved the study. Written informed consent was obtained from all participants. In addition to taking the patients' medical history and completing general and physical examinations, physicians will choose proper catheter size all perform catheterization using aseptic technique according to guidelines of proper aseptic catheterization. Urologist ensures comparable catheter size and amount of balloon inflation.

An aseptic non-touch technique (ANTT) must be used to obtain catheter specimen urine following these steps:

  • After catheterization apply clamp 10 cm distal to meatus then after few minutes clean the drainage port with alcohol and allow to dry then insert the syringe tip into the drainage port.
  • Three to five ml of urine collected in sterile disposable plastic cup at day zero (within 2 hours of catheterization), day ten and day twenty post catheterization.
  • The urine subjected to routine urine analysis, urine culture and sensitivity.

Appropriate statistical tests will be used to indicate the frequency and type of CAUTI as well as to assess catheter tolerance in each arm, followed by a comparison to conclude the results.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Noble Metal Alloy Coated Versus Silicone Foley Catheter in Patients With Long Term Catheterization: A Prospective Randomized Controlled Study
Actual Study Start Date : May 21, 2020
Estimated Primary Completion Date : May 21, 2021
Estimated Study Completion Date : June 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bactiguard urethral catheter
Group A: Fifty Patients with urethral catheter using noble metal alloy coated catheter (Bactiguard AB, Stockholm ,Sweden).
Device: Urethral catheter
All Patients will have urethral catheterization with either Noble Metal Alloy coated catheter or Silicon Foley catheter.

Active Comparator: Silicone Foley urethral catheter
Group B: Fifty Patients with urethral catheter using silicone Foley catheter (Well Lead, Guangzhou, China).
Device: Urethral catheter
All Patients will have urethral catheterization with either Noble Metal Alloy coated catheter or Silicon Foley catheter.




Primary Outcome Measures :
  1. Urinary tract infection [ Time Frame: 14 days ]
    incidence of culture documented symotomatic urinary tract infection


Secondary Outcome Measures :
  1. Catheter tolerance [ Time Frame: 14 days ]
    Catheter tolerance looks for discomfort or pain. Discomfort is an uncomfortable sensation due to the presence of a foreign object in the urethra without pain. The presence of actual pain is measured using VAS scoring system from zero to ten, so that a zero means no pain and a tenth means very severe pain.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

- Patient under age of 80 years old who need prolonged urethral catheterization (more than 2 weeks) as a method of bladder drainage.

Exclusion Criteria:

  • Patients with current or recent symptomatic urinary tract infection.
  • Antibiotic use currently or within 7 days prior to inclusion.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04825314


Contacts
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Contact: Tamer A Abou Youssif, MD +201101200076 tamer.abouyoussif@alexmed.edu.eg

Locations
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Egypt
Alexandria University Hospitals Recruiting
Alexandria, Egypt, 21646
Contact: Alaa Abdel Hady, MBBCH    +201223641864    medical_alaa@yahoo.com   
Contact: Tamer A Abou Youssif, MD    +201101200076    tamer.abouyoussif@alexmed.edu.eg   
Sponsors and Collaborators
Alexandria University
Publications:
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Responsible Party: Tamer Abou Youssif, Associate Professor, Alexandria University
ClinicalTrials.gov Identifier: NCT04825314    
Other Study ID Numbers: 0106462
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tamer Abou Youssif, Alexandria University:
catheter
UTI
Foley catheter
Nobel Metal Alloy catheter
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Catheter-Related Infections
Urologic Diseases