Ignite Creation Date:
2024-05-06 @ 3:58 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04825314
Status:
UNKNOWN
Last Update Posted:
2021-04-08
First Post:
2021-03-28
Brief Title:
Noble Meta Alloy Coated Catheters in Patients With Long Term Catheterization
Sponsor:
Alexandria University
Organization:
Alexandria University
Study Overview
Official Title:
Noble Metal Alloy Coated Versus Silicone Foley Catheter in Patients With Long Term Catheterization A Prospective Randomized Controlled Study
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None