| 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
|
|
|
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
|
|
|
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. |