FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2020/04/024608 [Registered on: 14/04/2020] Trial Registered Prospectively
Last Modified On: 19/07/2023
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Clinical equivalence study of two brands of polyester sutures (Trubond® and Ethibond) for fixation of the valvular prosthesis, in subjects undergoing aortic or mitral valve replacement  
Scientific Title of Study   Single blind, randomized study evaluating clinical equivalence of Trubond® vs Ethibond® braided polyester suture for fixation of the valvular prosthesis, using interrupted suture technique, in subjects undergoing aortic or mitral valve replacement 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
IND-HEALTHIUM- TRUBOND-2020-5  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ashok Kumar Moharana 
Designation  Chief Medical Officer 
Affiliation  Healthium Medtech Pvt.Ltd. 
Address  Healthium Medtech Pvt. Ltd., 472D, 13th cross, 4th phase, Peenya Industrial Area

Bangalore
KARNATAKA
560058
India 
Phone  9717887751  
Fax    
Email  ashok.m@healthiummedtech.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ashok Kumar Moharana 
Designation  Chief Medical Officer 
Affiliation  Healthium Medtech Pvt.Ltd. 
Address  Healthium Medtech Pvt. Ltd., 472D, 13th cross, 4th phase, Peenya Industrial Area

Bangalore
KARNATAKA
560058
India 
Phone  9717887751  
Fax    
Email  ashok.m@healthiummedtech.com  
 
Details of Contact Person
Public Query
 
Name  Dr Ashok Kumar Moharana 
Designation  Chief Medical Officer 
Affiliation  Healthium Medtech Pvt.Ltd. 
Address  Healthium Medtech Pvt. Ltd., 472D, 13th cross, 4th phase, Peenya Industrial Area

Bangalore
KARNATAKA
560058
India 
Phone  9717887751  
Fax    
Email  ashok.m@healthiummedtech.com  
 
Source of Monetary or Material Support  
Healthium Medtech Pvt. Ltd., 472D, 13th cross, 4th phase, Peenya Industrial Area, Bangalore KARNATAKA 560058 
 
Primary Sponsor  
Name  Healthium Medtech Pvt Ltd formerly Sutures India Pvt Ltd 
Address  Healthium Medtech Pvt. Ltd., 472D, 13th cross, 4th phase, Peenya Industrial Area, Bangaluru-560058 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr PS Seetharama Bhat  Sri Jayadeva Institute of Cardiovascular Sciences & Research  Department of Cardio-Thoracic Surgery, Sri Jayadeva Institute of Cardiovascular Sciences & Research Bannerghatta Road, 9th Block, Jayanagar
Bangalore
KARNATAKA 
9448046534

pssbhat@gmail.com 
Dr Neelam B Desai  Sri Sathya Sai Institute of Higher Medical Sciences  Department of Cardio Thoracic and Vascular Surgery, Sri Sathya Sai Institute of Higher Medical Sciences, Prasanthigram
Anantapur
ANDHRA PRADESH 
9440753129

neelam.d@sssihms.org.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, Sri Sathya Sai Institute of Higher Learning  Approved 
Sri Jayadeva Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ethibond® braided polyester suture  Braided polyester suture of Johnson & Johnson Inc, used for fixation of the valvular prosthesis, using interrupted suture technique, in subjects undergoing aortic or mitral valve replacement.  
Intervention  Trubond® braided polyester suture  Braided polyester suture of Healthium Medtech Private Limited, used for fixation of the valvular prosthesis, using interrupted suture technique, in subjects undergoing aortic or mitral valve replacement.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Subjects aged ≥18 or < 70 years
2. Subjects eligible for implantation of aortic or mitral valve through open heart surgery
3. Subjects who have given written informed consent
 
 
ExclusionCriteria 
Details  1. Subjects requiring multi-valve surgery
2. Subjects with a history of CABG or any valve surgery
3. Pregnancy and women of childbearing potential having positive urine pregnancy test prior to enrollment
4. Subjects with implanted pacemaker
5. Subjects with implantable cardiac defibrillator
6. Subjects with history of allergy to polyester or similar products
7. Subjects already participating in another surgical study
8. Subjects with history of bleeding disorders
9. Subjects who had the habit of drug abuse
10. Subjects who received an experimental drug or used an experimental medical device within 30 days prior to the planned start of procedure
11. Subjects unlikely to comply with surgical procedure or complete the scheduled follow up visit, in the opinion of investigator
12. Employees of the investigator or study center with direct involvement in the proposed study or other studies under the direction of that investigator or study center
13. Subjects with mental disorder, learning disability, or language barrier
14. Other indication-based exclusion, in opinion of investigator
 
 
Method of Generating Random Sequence   Permuted block randomization, variable 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. To assess the event rate of paravalvular leakage in both the groups.   within 26 weeks of index surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1. To assess the event rate of major adverse events (including death, stroke, myocardial infarction and surgical reintervention) in two groups
2. To evaluate tissue reaction, material problems and other adverse events among the two groups.
3.To evaluate postoperative discomfort and overall subject satisfaction score in both the groups
 
within 26 weeks of index surgery 
 
Target Sample Size   Total Sample Size="88"
Sample Size from India="88" 
Final Enrollment numbers achieved (Total)= "88"
Final Enrollment numbers achieved (India)="88" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)
Modification(s)  
25/12/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil as on date 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Valvular heart disease (VHD) is characterized by damage to or a congenital defect in one or more heart valves: mitral, aortic, tricuspid, and pulmonary. Heart valves have a single function: to permit unobstructed forward blood flow through the heart. Damaged or defective valves can cause two types of problems: either they fail to open properly (a condition called stenosis) impeding blood flow, or they leak (a condition called regurgitation) permitting back flow. There are no effective long-term medical therapies for severe VHD.

Valve replacement or repair performed either surgically or by catheter intervention are the only effective therapies. 

As a routine practice, polyester suture material is used to fix the valves. After the valve replacement one of the problem which can occur is paravalvular leak. The causes include fibrosis or calcification of the annulus which fails to hold the sutures, rarely infections, improper suturing and undue stress on the suture lines. 

Immediate post-operative studies have identified minute suture leaks in 20% and hemodynamically significant leaks only in 1–5% of subjects.

In this study we plan to compare two commonly used brands of braided polyester sutures for fixation of the valvular prosthesis.

This study is designed to compare clinical equivalence of Trubond (Healthium) and Ethibond (Johnson & Johnson) braided polyester suture for fixation of the valvular prosthesis, using interrupted suture technique, in subjects undergoing Aortic or mitral valve replacement.

 
Close