Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization

Not Applicable

• Conditions: Catheter Infection; Urinary Tract Infections; Catheter-Related Infections; Infection
• Interventions: Device: Urethral catheter

• Registration Number: NCT04825314
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2020-05-21
• Study First Submitted: 2021-03-28
• Study First Submitted QC: 2021-03-28
• Status Verified: 2021-04
• Study First Posted: 2021-04-01
• Last Update Submitted: 2021-04-04
• Last Update Posted: 2021-04-08
• Primary Completion: 2021-05-21
• Study Completion: 2021-06-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Silicone Foley urethral catheter	Urethral catheter	Group B: Fifty Patients with urethral catheter using silicone Foley catheter (Well Lead, Guangzhou, China).
Bactiguard urethral catheter	Urethral catheter	Group A: Fifty Patients with urethral catheter using noble metal alloy coated catheter (Bactiguard AB, Stockholm ,Sweden).

Primary Outcome Measures

Name	Time	Method
Urinary tract infection	14 days	incidence of culture documented symotomatic urinary tract infection

Secondary Outcome Measures

Name	Time	Method
Catheter tolerance	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.

Trial Locations

Locations (1)

Alexandria University Hospitals; 🇪🇬 Alexandria, Egypt