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CTRI Number  CTRI/2021/05/033310 [Registered on: 03/05/2021] Trial Registered Prospectively
Last Modified On: 30/04/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device
Preventive
Process of Care Changes 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Bactriguard catheter versus Foleys catheter  
Scientific Title of Study   Bactriguard catheter versus Foleys catheter in reduction of UTI among Urethroplasty patients, at AIIMS, BBSR Randomized controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kalaivani 
Designation  Tutor/ Clinical Instructor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  4th Floor, College of Nursing, AIIMS, Bhubaneswar, Sijua, Patrapada, Dumduma, Odisha
4th Floor, College of Nursing, AIIMS, Bhubaneswar, Sijua, Patrapada, Dumduma, Odisha
Khordha
ORISSA
751019
India 
Phone  8260044966  
Fax    
Email  kalaivanistella@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Kalaivani 
Designation  Tutor/ Clinical Instructor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  4th Floor, College of Nursing, AIIMS, Bhubaneswar, Sijua, Patrapada, Dumduma, Odisha
4th Floor, College of Nursing, AIIMS, Bhubaneswar, Sijua, Patrapada, Dumduma, Odisha

ORISSA
751019
India 
Phone  8260044966  
Fax    
Email  kalaivanistella@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Kalaivani 
Designation  Tutor/ Clinical Instructor 
Affiliation  All India Institute of Medical Sciences, Bhubaneswar 
Address  4th Floor, College of Nursing, AIIMS, Bhubaneswar, Sijua, Patrapada, Dumduma, Odisha
4th Floor, College of Nursing, AIIMS, Bhubaneswar, Sijua, Patrapada, Dumduma, Odisha

ORISSA
751019
India 
Phone  8260044966  
Fax    
Email  kalaivanistella@gmail.com  
 
Source of Monetary or Material Support  
BIP Foley catheter Latex Imported & Marketed by Neon Laboratories LTD Licence no IL/MD -000504 -RC /MD -0000067 140,Damji shamji industrial complex,28 ,Mahal industrial Estate ,Mahakali Caves Rosd Mumbai  
 
Primary Sponsor  
Name  ICMR 
Address  AIIMS, Bhubaneswar 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kalaivani  AIIMS, Bhubaneswar  Urology dept,ROOM NO :206 AIIMS, Bhubnaeswar, Sijua, Patrapada, Dumduma
Khordha
ORISSA 
8260044966

kalaivanistella@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, AIIMS Bhbaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N358||Other urethral stricture,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Catheter  Bactriguard catheter 
Intervention  Catheter  Foleys catheter 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Male 
Details  undergone Urethro plasty surgery and
-willing to participate
-available at the time of Data collection period
-patient requires long term indwelling urinary catheterization minimum 28 days
 
 
ExclusionCriteria 
Details  catheterized through Suprapubical puncture site
-long term critically ill & admitted in ICU setting
- immunoCompromised Patients – HIV & receiving Immuno compromised Drugs.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Rates of post-op UTI   3rd day and 28th day after the catheter insertion. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="178"
Sample Size from India="178" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/05/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="30" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The study will be published in selected journal. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The risk of CAUTI increases with the number of days of catheterization and if the patients´s immune system is weak. Groups at risk of CAUTI  include the critically ill and patients with urological  obstruction ,malignancies and neurological diseases.

                        BIP Foley Catheter has been shown to reduce CAUTI in a cost effective way. Several health economic evaluations have been conducted in Europe and USA. In one of these, a large, prospective, randomized study of almost 28 000 patients, Bactiguard coated catheters were shown to offer significant annual cost savings when considering the excess cost of CAUTI. In another 2-year prospective surveillance study of 10 patient care units, the introduction of a Bactiguard coated urinary catheter was associated with a significant decline in CAUTI and led to reduced costs. The costs savings were present in a wide variety of reimbursement systems.

       Bactiguard coated products have been used in a large number of clinical studies and evaluations (1986–2015) involving over 100,000 patients. In peer-reviewed studies looking specific on the  reduction of  CAUTI. In another 2-year prospective surveillance study of 10 patient care units, the introduction of a Bactiguard coated urinary catheter was associated with a significant decline in CAUTI and led to reduced costs.

       The costs savings were present in a wide variety of reimbursement at the incidence of symptomatic CAUTIs in patients with >2 days of catheterization (in line with current standards), the weighted average reduction of infection was 35%. In certain studies a much larger reduction, of up to 70%, was observed. In addition to that use of  Bactriguard coated catheter demonstration shown decreased bacterial adhesion ,which in turn prevents biofilm formation and subsequent infection.

 
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