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.
None
Patients who refuse to participate in the trial.
Patients who do not read or speak English.
Patient with allergy to surgical adhesives or sutures
Single group
Knotless Barbed Sutures
DeviceThis 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
DeviceSkin Surface: Final closure using the DERMABOND™ PRINEO™ system, which combines 2-octyl cyanoacrylate topical adhesive with a self-adhesive polymer mesh tape.
Incidence of Sternal Wound Complications (Composite Endpoint)
The primary outcome is a composite measure of treatment success or failure. A participant is considered a success only if they experience none of the following: Deep Sternal Wound Infection (DSWI), Superficial Sternal Wound Infection (SSWI), general Surgical Site Infection (SSI), or Sternal Dehiscence (SD). A participant is considered a failure if any one of these complications occurs. Sternal wound sites will be classified by blinded personnel using the Centers for Disease Control and Prevention (CDC) 4-level classification system. Sternal Dehiscence (SD) will be determined via a visual assessment by a cardiac surgeon and recorded as a binary result (yes or no).
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Unity Health Toronto
Lead sponsor
Johnson & Johnson
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
