Noble Meta Alloy Coated Catheters in Patients With Long Term

Status Recruiting

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04825314
Study type	Interventional
Source	Alexandria University
Contact	Tamer A Abou Youssif, MD
Phone	+201101200076
Email	tamer.abouyoussif@alexmed.edu.eg
Status	Recruiting
Phase	N/A
Start date	May 21, 2020
Completion date	June 21, 2021

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms