Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization

Infection Clinical Trial

Official title:

Noble Metal Alloy Coated Versus Silicone Foley Catheter in Patients With Long Term Catheterization: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04825314
• Other study ID #: 0106462
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2020
• Est. completion date: June 21, 2021

Study information

• Verified date: April 2021
• Source: Alexandria University
• Contact: Tamer A Abou Youssif, MD
• Phone: +201101200076
• Email: tamer.abouyoussif[@]alexmed.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 21, 2021
• Est. primary completion date: May 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Catheter Infection
• Catheter-Related Infections
• Communicable Diseases
• Infection
• Urinary Tract Infections

Intervention

Device:
• Urethral catheter
All Patients will have urethral catheterization with either Noble Metal Alloy coated catheter or Silicon Foley catheter.

Locations

Country	Name	City	State
Egypt	Alexandria University Hospitals	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary tract infection	incidence of culture documented symotomatic urinary tract infection	14 days
Secondary	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.	14 days