Efficacy of Sternum Guard in Post Cardiac Surgery Patient (NCT05229276) | Clinical Trial Compass
CompletedNot Applicable
Efficacy of Sternum Guard in Post Cardiac Surgery Patient
Indonesia414 participantsStarted 2020-05-17
Plain-language 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 modalities are materials used during sternotomy for covering the sewn sternal edge. The primary outcomes of this study comprised of four parameters; namely surgical site infection (superficial or deep infection), sternal dehiscence, hemostatic effect, and surgeon's satisfaction rate. The first three primary outcomes were assessed during the operation, at the end of the hospital stay, 14 days, and 30-days postoperative.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Surgical site infection
Timeframe: within 30 days after the sternotomy surgery performed
2
Haemostatic effect
Timeframe: immediately after the median sternotomy surgery finished