Catheter in the Prevention of Urinary Tract Infections and Crystallization Study(CPUTICS)

T

Tongji University

Status

Not yet enrolling

Conditions

Urinary Catheter

Treatments

Other: Types of catheters

Study type

Interventional

Funder types

Other

Identifiers

NCT06230042
CPUTICS-01

Details and patient eligibility

About

This is a single-center randomized controlled trial in comparison of Parylene-Coated versus Silicone Catheters in the Prevention of Urinary Tract Infections and Crystallization.

Full description

This study was a single-center randomized controlled trial, enrolling patients with indwelling urinary catheterization time greater than 2 weeks, and comparing the incidence of urinary tract infections in the two groups with different indwelling urinary catheter times by retaining mid-stream urine specimens for bacterial cultures on the 3rd, 7th, 10th, and 14th days after urinary catheter placement. And after removal of the urinary catheter,1-cm sections were taken from the head end and center of each urinary catheter, and the crystal deposition inside the catheter was observed using a scanning electron microscope. The incidence of urinary tract infections and crystal deposition on the inner wall of the catheter were compared between the patients in the matte catheter group (Parylene-coated) and the patients in the glossy catheter group (plain silicone) during the period of catheterization, so as to evaluate the effectiveness of the two types of catheters in the clinical application.

Enrollment

80 estimated patients

Sex

Male

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. age greater than 18 years;
  2. indwelling urinary catheter for ≥14 days;
  3. fully understand the clinical trial protocol and sign the informed consent;

Exclusion criteria

  1. patients with confirmed urinary tract infection before indwelling urinary catheter;
  2. those with renal dysfunction;
  3. those who are allergic to silicone or silicone material;
  4. those with low immunity susceptible to infection;
  5. those who have participated in other clinical trials within 3 months;
  6. others who are judged by the investigator to be unsuitable for clinical trials;

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

80 participants in 2 patient groups

Parylene-Coated Catheter
Experimental group
Description:
The type of catheter used during a patient's indwelling urinary catheterization is Parylene-Coated Catheter
Treatment:
Other: Types of catheters
Silicone Catheter
Active Comparator group
Description:
The type of catheter used during a patient's indwelling urinary catheterization is Silicone Catheter
Treatment:
Other: Types of catheters

Trial contacts and locations

1

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Central trial contact

shuaidong wang; haifeng wang

Data sourced from clinicaltrials.gov

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