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Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients
Sponsor: Unity Health Toronto
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.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
401
Start Date
2026-05-01
Completion Date
2028-05-01
Last Updated
2026-04-02
Healthy Volunteers
No
Conditions
Interventions
Knotless Barbed Sutures
This intervention replaces traditional non-barbed, knotted sutures with a specialized knotless and adhesive system. The strategy is characterized by the following layer-specific applications: Deep Tissue (Presternal Fascia): Application of STRATAFIX™ Symmetric barbed sutures. Subcutaneous and Subcuticular Layers: Use of STRATAFIX™ Spiral MONOCRYL™ Plus and/or STRATAFIX™ Spiral PDS™ Plus. These sutures feature an antibacterial triclosan coating designed to reduce the risk of surgical site infections.
Mesh-based Topical Skin Adhesive
Skin Surface: Final closure using the DERMABOND™ PRINEO™ system, which combines 2-octyl cyanoacrylate topical adhesive with a self-adhesive polymer mesh tape.