Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complicat… (NCT07507409) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients
401 participantsStarted 2026-05-01
Plain-language summary
The goal of this clinical trial is to learn if a new method of closing the breastbone after heart bypass surgery can improve healing and reduce complications in adults undergoing coronary artery bypass graft (CABG) surgery.
The main questions it aims to answer are:
Does this new closure method reduce infections and wound reopening? Does it improve healing, recovery, and overall patient outcomes?
Researchers will compare patients who receive the new closure method to past patients who received the standard method to see if outcomes are better.
Participants will:
Receive the new closure method during their surgery (as part of standard care) Be followed during their normal recovery up to their 6-week follow-up visit Complete a short quality-of-life questionnaire (about 10 minutes) Have their recovery assessed, including healing, complications, and hospital use
Researchers will also look at quality of life, heart complications, hospital readmissions, antibiotic use, scar appearance, and overall costs to understand the full impact of the new method.
Who can participate
Age range
18 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 aged 18 years and older undergoing CABG surgery.
Exclusion Criteria:
* Patients who refuse to participate in the trial.
* Patients who do not read or speak English.
* Patient with allergy to surgical adhesives or sutures
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.
1This trial is testing two specific wound closure products — STRATAFIX™ sutures and DERMABOND™ skin glue — after open-heart bypass surgery; is either of these techniques something you already use, and how does what you currently do compare to what this trial is testing?
2Since this trial is Phase 4, does that mean these products are already approved and used in other surgeries, and what does that tell us about how much is already known about their safety compared to standard sternal closure methods?
3The trial isn't recruiting patients yet — how long do you think it might be before it opens, and would waiting to potentially join it be reasonable given my situation, or is it better to proceed with surgery now?
4This study is specifically looking at reducing sternal wound infections and serious complications like mediastinitis after bypass surgery — based on my personal health profile, how high is my risk for those kinds of wound problems, and would that make this trial especially relevant for me to discuss further?
5If I'm not able to or choose not to participate in this trial, what wound closure techniques would you use for my bypass surgery, and how do they compare to the STRATAFIX™ and DERMABOND™ approach being studied here?
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
Incidence of Sternal Wound Complications (Composite Endpoint)