Parylene-Coated Versus Silicone Catheters in the Prevention of Urinary Tract Infections and Crystallization: A Single-Center Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Catheter
- Sponsor
- Shanghai East Hospital
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Catheter-Associated Urinary Tract Infection (CAUTI) Incidence
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •age greater than 18 years;
- •indwelling urinary catheter for ≥14 days;
- •fully understand the clinical trial protocol and sign the informed consent;
Exclusion Criteria
- •patients with confirmed urinary tract infection before indwelling urinary catheter;
- •those with renal dysfunction;
- •those who are allergic to silicone or silicone material;
- •those with low immunity susceptible to infection;
- •those who have participated in other clinical trials within 3 months;
- •others who are judged by the investigator to be unsuitable for clinical trials;
Outcomes
Primary Outcomes
Catheter-Associated Urinary Tract Infection (CAUTI) Incidence
Time Frame: the Day 3,Day 7, Day 10 and Day 14 after catheterization
The mid-stream urine specimens on the 3rd, 7th, 10th and 14th days after catheterization were taken for bacterial culture to compare the incidence of urinary tract infections in the two groups at different times of indwelling urinary catheterization. Diagnostic criteria: patients with urinary tract infections that occurred after indwelling urinary catheterization, or within 48 h of catheter removal. Urine bacterial culture of Gram-positive cocci colonies ≥104cfu/ml and Gram-negative bacilli colonies ≥105cfu/ml was judged as urinary tract infection.
Crystal deposits on the inner wall of the catheter
Time Frame: Day 14 after catheterization
① After removing the urinary catheter, a 1-cm section was taken from the head end and the center of each urinary catheter, and the crystal deposition inside the catheter was observed using a scanning electron microscope, and the average scores of the two groups were calculated according to the scores in the table below, comparing the effectiveness of the two groups of urinary catheters in preventing crystallization. ② Record the details and number of blockages that occurred during the indwelling catheterization period, and calculate the blockage rate of the two groups.
Secondary Outcomes
- Evaluation of urethral irritation response(Day 1 after catheterization)
- Measuring the temperature of bladder urine(the Day 3,Day 7, Day 10 and Day 14 after catheterization)