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
|
|
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
|
|
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. |