Infection Clinical Trial
Official title:
Noble Metal Alloy Coated Versus Silicone Foley Catheter in Patients With Long Term Catheterization: A Prospective Randomized Controlled Study
NCT number | NCT04825314 |
Other study ID # | 0106462 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 21, 2020 |
Est. completion date | June 21, 2021 |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Alexandria University Hospitals | Alexandria |
Lead Sponsor | Collaborator |
---|---|
Alexandria University |
Egypt,
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
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 |
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