Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization

  • STATUS
    Recruiting
  • days left to enroll
    42
  • participants needed
    100
  • sponsor
    Alexandria University
Updated on 17 April 2021

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.

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.

Details
Condition Catheter related infection, Infection, Infection, Urinary tract infection, Recurrent Urinary Tract Infection, Recurrent Urinary Tract Infections, Catheter Infection, Urinary Tract Infections, catheter-related infection, infections, catheter-associated, urinary tract infection (uti), urinary infection, recurrent utis, catheter infections
Treatment Urethral catheter, Urethral catheter
Clinical Study IdentifierNCT04825314
SponsorAlexandria University
Last Modified on17 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have any of these conditions: Recurrent Urinary Tract Infection or catheter infections or Catheter related infection or urinary tract infection (uti) or recurrent utis or Catheter ...?
Do you have any of these conditions: recurrent utis or Catheter Infection or Catheter related infection or Urinary tract infection or catheter-related infection or Recurrent Urinary Tract...?
Do you have any of these conditions: Recurrent Urinary Tract Infection or catheter-related infection or Catheter Infection or infections, catheter-associated or urinary tract infection (u...?
Do you have any of these conditions: Urinary Tract Infections or catheter-related infection or Urinary tract infection or urinary tract infection (uti) or Infection or recurrent utis or R...?
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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