Clinical Trial

Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients

Not Yet Recruiting Phase 4
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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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-03-27.
Trial Details
NCT Number NCT07507409
Lead Sponsor Unity Health Toronto
Collaborators: Johnson & Johnson
Conditions Cardiovascular Disease, Surgical Site Infection, Superficial Sternal Wound Infection, Mediastinitis
Enrollment 401 participants
Start Date 2026-05-01
Primary Completion 2027-11-01 (estimated)
Study Completion 2028-05-01 (estimated)
Updated on ClinicalTrials.gov 2026-04-13