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Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization

Primary Purpose

Urinary Tract Infections, Catheter Infection, Catheter-Related Infections

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Urethral catheter
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urinary Tract Infections focused on measuring catheter, UTI, Foley catheter, Nobel Metal Alloy catheter

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Alexandria University HospitalsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Bactiguard urethral catheter

Silicone Foley urethral catheter

Arm Description

Group A: Fifty Patients with urethral catheter using noble metal alloy coated catheter (Bactiguard AB, Stockholm ,Sweden).

Group B: Fifty Patients with urethral catheter using silicone Foley catheter (Well Lead, Guangzhou, China).

Outcomes

Primary Outcome Measures

Urinary tract infection
incidence of culture documented symotomatic urinary tract infection

Secondary Outcome Measures

Catheter tolerance
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.

Full Information

First Posted
March 28, 2021
Last Updated
April 4, 2021
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT04825314
Brief Title
Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization
Official Title
Noble Metal Alloy Coated Versus Silicone Foley Catheter in Patients With Long Term Catheterization: A Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2020 (Actual)
Primary Completion Date
May 21, 2021 (Anticipated)
Study Completion Date
June 21, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Tract Infections, Catheter Infection, Catheter-Related Infections, Infection
Keywords
catheter, UTI, Foley catheter, Nobel Metal Alloy catheter

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bactiguard urethral catheter
Arm Type
Active Comparator
Arm Description
Group A: Fifty Patients with urethral catheter using noble metal alloy coated catheter (Bactiguard AB, Stockholm ,Sweden).
Arm Title
Silicone Foley urethral catheter
Arm Type
Active Comparator
Arm Description
Group B: Fifty Patients with urethral catheter using silicone Foley catheter (Well Lead, Guangzhou, China).
Intervention Type
Device
Intervention Name(s)
Urethral catheter
Intervention Description
All Patients will have urethral catheterization with either Noble Metal Alloy coated catheter or Silicon Foley catheter.
Primary Outcome Measure Information:
Title
Urinary tract infection
Description
incidence of culture documented symotomatic urinary tract infection
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Catheter tolerance
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tamer A Abou Youssif, MD
Phone
+201101200076
Email
tamer.abouyoussif@alexmed.edu.eg
Facility Information:
Facility Name
Alexandria University Hospitals
City
Alexandria
ZIP/Postal Code
21646
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alaa Abdel Hady, MBBCH
Phone
+201223641864
Email
medical_alaa@yahoo.com
First Name & Middle Initial & Last Name & Degree
Tamer A Abou Youssif, MD
Phone
+201101200076
Email
tamer.abouyoussif@alexmed.edu.eg

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28057985
Citation
Aljohi AA, Hassan HE, Gupta RK. The efficacy of noble metal alloy urinary catheters in reducing catheter-associated urinary tract infection. Urol Ann. 2016 Oct-Dec;8(4):423-429. doi: 10.4103/0974-7796.192099.
Results Reference
background

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Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization

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