A Phase 4 interventional study of Knotless Barbed Sutures and Mesh-based Topical Skin Adhesive in Cardiovascular Disease, Surgical Site Infection and Superficial Sternal Wound Infection, sponsored by Unity Health Toronto. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Unity Health Toronto · Phase 4, Interventional, and Prevention
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.
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.
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:
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.
5,368 studies on the registry are indexed under Cardiovascular Diseases; 939 are open to participants now.
This study's planned enrollment of 401 is above the median of 100 across 3,084 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →Unity Health Toronto is the lead sponsor of 447 studies on the registry; 82 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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- Patients aged 18 years and older undergoing CABG surgery.
Exclusion Criteria:
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 · Device: Mesh-based Topical Skin Adhesive
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.
Also known as: STRATAFIX™ Symmetric barbed sutures, STRATAFIX™ Spiral MONOCRYL™ Plus, STRATAFIX™ Spiral PDS™ Plus
Skin Surface: Final closure using the DERMABOND™ PRINEO™ system, which combines 2-octyl cyanoacrylate topical adhesive with a self-adhesive polymer mesh tape.
Also known as: DERMABOND™ PRINEO™
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).
Time frame: 6 weeks post-operatively
No study locations are listed for this record.
Plan to share: Undecided
Start is estimated for May 2026; primary completion for Nov 2027, 18 months later.
Of 107 non-industry phase 4 interventional studies under Cardiovascular Diseases, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 76. This study's planned 18 months is below that.
Counting every sponsor, half of 113 studies reached it within 46 months; a quarter within 26 and three quarters within 64.
Cardiovascular Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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