Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization

Last updated: April 4, 2021
Sponsor: Alexandria University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Catheter Complications

Urinary Tract Infections

Treatment

N/A

Clinical Study ID

NCT04825314
0106462
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 100
Study Start date:
May 21, 2020
Estimated Completion Date:
June 21, 2021

Study 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.

Connect with a study center

  • Alexandria University Hospitals

    Alexandria, 21646
    Egypt

    Active - Recruiting

+−

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.