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

April 7, 2026 updated by: Unity Health Toronto

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Cardiovascular disease (CVD) represents a major burden of morbidity and mortality. Approximately 8.5% of Canadian adults live with CVD and it is the second leading cause of death in Canada. In Canada, over 30,000 cardiac surgical procedures are performed each year, the vast majority via a sternotomy. Sternotomy complications can be life-threatening especially when they beget sternal dehiscence (SD) and deep sternal wound infection (DSWI). It is often unclear whether SD caused SWI or vice versa. Superficial sternotomy complications have a 5-10% occurrence, with DSWIs occurring in 0.2-5% of patients. When sternal complications do occur, patient-reported outcomes are impacted and mortality rates can be as high as 10-30%.

Typically a combination of steel wires and synthetic, absorbable sutures are used to close sternal incisions. Recently, the development of barbed sutures have been shown to reduce knot slippage and complications related to knot tying. Insufficient data on their feasibility and safety in cardiac surgery has limited their use in the field. Furthermore, research has demonstrated the benefits of otherskin closure systems, that combines 2-octyl cyanoacrylate with a self-adhesive polymer mesh tape, but their effects have been minimally investigated on sternal wound closures (SWCs). Moreover, the combinatory effects of barbed sutures and mesh-based antibiotic skin adhesives on SWCs have not been investigated.

Surgical site infections (SSIs) in CABG are often sternal wound infections which are classified as deep sternal wound infection (DSWI) and superficial sternal wound infection (SSWI). DSWIs, also known as mediastinitis, have an incidence of 1-5% and are associated with the highest SWI mortality rates ranging between 10-47%. Mediastinitis is the inflammation of the tissue and organs within the mediastinum (an area in the chest that contains vital organs such as the heart, trachea, and esophagus). In contrast, SSWIs have a slightly higher incidence of 0.5-10%, with a much lower mortality rate of 0.5-5%, and affect the skin, subcutaneous tissue, and pectoralis fascia. Considering DSWI can affect highly protected organs in the mediastinum, it is predicted that DSWI usually occurs due to preoperative contamination, meanwhile, SSWI is a more superficial infection and is hypothesized to begin on the epidermis and move inside, through the tissue layers. Importantly, DSWI and SSWI share similar risk factors such as diabetes, pre- and post-operative complications, and obesity.

The goal of the study is to determine if implementing a combination of barbed sutures (STRATAFIX™) and a mesh-based topical skin adhesive (DERMABOND™ PRINEO™ ) on sternal wound closures will reduce the incidence of sternal complications, such as sternal dehiscence and sternal wound infection, in patients undergoing coronary artery bypass grafting (CABG) surgery. The investigators hypothesize that this combined approach will significantly reduce sternal dehiscence and wound infections, leading to a measurable decrease in patient morbidity and mortality.

The primary objective of this study is to assess whether the use of STRATAFIX™ barbed sutures, featuring antibacterial triclosan coating, and DERMABOND™ PRINEO™ wound closure system which combines 2-octyl cyanoacrylate with a polymer mesh will reduce sternal wound closure complications in CABG patients over a period of 6-weeks. The secondary objectives are to compare the cost-effectiveness for the hospital and quality of life in patients who have received this novel approach for sternal wound closure, versus the customary materials (i.e., non-barbed, no mesh-based antibiotic skin adhesives) used by cardiac surgeons.

The primary outcomes will include the following:

1) The incidence of DSWI, SSWI, SSI, and SD.

  1. Sternal wound sites will be classified based on a blinded grading using the Centers for Disease Control and Prevention 4-level classification system13.

  2. The cardiac surgeon will perform a visual assessment to determine the presence of SD, recording the outcome as a binary result (yes or no).

    The secondary outcomes will include the following:

    1. Quality of Life Assessment (QALY) will be completed using the EQ-5D questionnaire which measures mobility, self-care, usual activities, pain/discomfort, and anxiety/depression14. The questionnaire will be distributed for completion at the 6-week post-operative visit.
    2. Should SD occur, its severity will be measured using a gap measurement. 3) All-cause mortality.

    4) Incidence of ST- and non-ST-elevation myocardial infarction (STEMI and NSTEMI, respectively).

    2 5) Utilization of hospital resources, specifically, the frequency of hospital readmission, length of stay at the hospital, and number of revisions and/or reoperations for sternal closure due to infection or dehiscence.

    6) Antibiotic dosage and frequency. 7) Aesthetic assessment of the sternal closure site. 8) Cost-effectiveness of the materials used will be analyzed related to the EQ-5D questionnaire responses.

Study Type

Interventional

Enrollment (Estimated)

401

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.

Other Names:
  • STRATAFIX™ Symmetric barbed sutures
  • STRATAFIX™ Spiral MONOCRYL™ Plus
  • STRATAFIX™ Spiral PDS™ Plus
Device: 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.
Other Names:
  • DERMABOND™ PRINEO™

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Sternal Wound Complications (Composite Endpoint)
Time Frame: 6 weeks post-operatively

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).
6 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Unity Health Toronto

Collaborators

Johnson & Johnson

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

March 27, 2026

First Posted (Actual)

April 2, 2026

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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