Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization

Sponsor

Alexandria University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04825314

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

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	N/A

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 Design

Study Type:

Interventional

Anticipated 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

Anticipated Primary Completion Date :

May 21, 2021

Anticipated Study Completion Date :

Jun 21, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Urinary tract infection [14 days]
incidence of culture documented symotomatic urinary tract infection

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.