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

Sponsor
Unity Health Toronto
Study ID
NCT07507409
Phase
PHASE4
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Cardiovascular Disease
  • Mediastinitis
  • Superficial Sternal Wound Infection
  • Surgical Site Infection

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Knotless Barbed Sutures — DEVICE
    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 — DEVICE
    Skin Surface: Final closure using the DERMABOND™ PRINEO™ system, which combines 2-octyl cyanoacrylate topical adhesive with a self-adhesive polymer mesh tape.

Study Details

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 Dates

First listed
Apr 2, 2026
Start date
May 1, 2026
Status verified
Mar 2026
Primary completion
Nov 1, 2027
Completion
May 1, 2028

Study Design

Enrollment
401 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: STRATAFIX™ and DERMABOND™ PRINEO™ Intervention Group
    This experimental arm evaluates a dual-component sternal closure strategy in 401 patients undergoing CABG surgery. The intervention replaces traditional non-barbed sutures with a combination of STRATAFIX™ barbed sutures and DERMABOND™ PRINEO™ mesh-based adhesive.

Primary Outcome Measure

Incidence of Sternal Wound Complications (Composite Endpoint) [ Time Frame: 6 weeks post-operatively ]

Related Studies