NCT04825314

Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Urethral catheter	All Patients will have urethral catheterization with either Noble Metal Alloy coated catheter or Silicon Foley catheter.

Timeline

• Start date: 2020-05-21
• Primary completion: 2021-05-21
• Completion: 2021-06-21
• First posted: 2021-04-01
• Last updated: 2021-04-08

Locations

1 site across 1 country: Egypt