Status:
COMPLETED
Efficacy of Sternum Guard in Post Cardiac Surgery Patient
Lead Sponsor:
Indonesia University
Collaborating Sponsors:
Vygon GmbH & Co. KG
Conditions:
Coronary Artery Disease
Valvular Heart Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a single-center, single-blind, randomized parallel superiority trial comparing two groups; Sternum GuardTM as the treatment arm and Bone Wax as the active control group. Both investigated moda...
Detailed Description
A single center randomized controlled clinical trial was conducted at Harapan Kita National Cardiovascular Center, Jakarta, Indonesia as the tertiary cardiovascular referral hospital. The RCT was cond...
Eligibility Criteria
Inclusion
- Patients ages \> 18 years old
- Patients who are scheduled electively for cardiac surgery
- Cardiac surgery with the usage of cardiopulmonary bypass machine
- Patients who are agreed to participate in this study
Exclusion
- Patients who are scheduled for surgery in emergency or urgent manner
- Patients with the history of uncontrolled hypertension and uncontrolled diabetes mellitus.
- Patients with the history of past cardiac surgery
- Drop - out Criteria:
- Patients who are pronounced death on operation table
- Patients who are pronounced death within hospitalization
- Patients who are lost to follow up (Day 30 post-operative)
- Patients who are not committed for the whole stage of the research
Key Trial Info
Start Date :
May 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2021
Estimated Enrollment :
414 Patients enrolled
Trial Details
Trial ID
NCT05229276
Start Date
May 17 2020
End Date
October 30 2021
Last Update
February 8 2022
Active Locations (1)
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1
National Cardiovascular Center Harapan Kita
Jakarta, DKI Jakarta, Indonesia, 11410