AzTrials
AzTrials

Cardiovascular DiseasePhase 4NCT07507409

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

A Phase 4 study testing Knotless Barbed Sutures and Mesh-based Topical Skin Adhesive in people with Cardiovascular Disease and Surgical Site Infection, run by Unity Health Toronto.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Knotless Barbed Sutures and Mesh-based Topical Skin Adhesive
Could I receive a placebo?
No, everyone receives an active treatment
How many people
401 participants
Where
No sites listed yet
Study dates
1 May 2026to 1 May 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18 years and older undergoing CABG surgery.

Who cannot join

  • Patients who refuse to participate in the trial.
  • Patients who do not read or speak English.
  • Patient with allergy to surgical adhesives or sutures

About this study

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:

Read more

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.

Read the 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.
  2. Sternal wound sites will be classified based on a blinded grading using the Centers for Disease Control and Prevention 4-level classification system13.
  3. 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. 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.
  5. Should SD occur, its severity will be measured using a gap measurement. 3) All-cause mortality.
  6. 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.
  7. 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.
Being tested
Knotless Barbed Sutures, Mesh-based Topical Skin Adhesive
Keywords
STRATAFIX, DERMABOND, Sternal Closure, Suture, CABG
Medical subject headings
Cardiovascular Diseases, Surgical Wound Infection, Mediastinitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Knotless Barbed SuturesDevice

    Also called STRATAFIX™ Symmetric barbed sutures, STRATAFIX™ Spiral MONOCRYL™ Plus, STRATAFIX™ Spiral PDS™ Plus

    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 AdhesiveDevice

    Also called DERMABOND™ PRINEO™

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

Study groups in NCT07507409
Study groupRoleWhat they receive
STRATAFIX™ and DERMABOND™ PRINEO™ Intervention GroupExperimentalThis 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.
Receives: Device: Knotless Barbed Sutures; Device: Mesh-based Topical Skin Adhesive

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 weeks post-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2026
  2. Study start1 May 2026 (estimated)
  3. Primary completion1 Nov 2027 (estimated)
  4. Study completion1 May 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Model description
This study is a single-center, single-arm, non-randomized controlled trial designed to evaluate a novel sternal closure technique. The study model follows a prospective intervention with a retrospective comparison to historical data. The trial consists of a single treatment arm where all 401 participants receive the combination of STRATAFIX™ barbed sutures and DERMABOND™ PRINEO™ mesh-based adhesive. The intervention group will be compared against historic controls from the St. Michael's Hospital database. Recruitment and follow-up are expected to span 18 months, followed by 6 months of data analysis and manuscript preparation.
Masking
None (open label)
Enrolment
401 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07507409
Sponsor's protocol ID
25-277
Status last verified
Mar 2026
First submitted
27 Mar 2026
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Undecided

Publications

  • Krishnamoorthy B, Shepherd N, Critchley WR, Nair J, Devan N, Nasir A, Barnard JB, Venkateswaran RV, Waterworth PD, Fildes JE, Yonan N. A randomized study comparing traditional monofilament knotted sutures with barbed knotless sutures for donor leg wound closure in coronary artery bypass surgery. Interact Cardiovasc Thorac Surg. 2016 Feb;22(2):161-7. doi: 10.1093/icvts/ivv314. Epub 2015 Nov 20.

    PubMed 26590381

  • Haenen, F. W. N., Guy, T. S. & Rodrigus, I. Knotless Closure of the Cardiac Venous Cannulation Site Using Barbed Suture: A First Step in Including Barbed Sutures in our Cardiac Surgery Practice. Surg. Case Rep. 2021, 1-4 (2021).

  • EQ-5D-5L. EuroQol https://euroqol.org/information-and-support/euroqol-instruments/eq-5d5l/.

  • Herman TF, Popowicz P, Bordoni B. Wound Classification. 2023 Aug 17. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK554456/

    PubMed 32119343

  • Lemaignen A, Birgand G, Ghodhbane W, Alkhoder S, Lolom I, Belorgey S, Lescure FX, Armand-Lefevre L, Raffoul R, Dilly MP, Nataf P, Lucet JC. Sternal wound infection after cardiac surgery: incidence and risk factors according to clinical presentation. Clin Microbiol Infect. 2015 Jul;21(7):674.e11-8. doi: 10.1016/j.cmi.2015.03.025. Epub 2015 Apr 14.

    PubMed 25882356

  • Pastene B, Cassir N, Tankel J, Einav S, Fournier PE, Thomas P, Leone M. Mediastinitis in the intensive care unit patient: a narrative review. Clin Microbiol Infect. 2020 Jan;26(1):26-34. doi: 10.1016/j.cmi.2019.07.005. Epub 2019 Jul 12.

    PubMed 31306791

  • Haenen FW, Van Oostende C, Allegaert M, Round KJ, Rosen JL, Guy ST, Rodrigus I. Prosthesis-prosthesis anastomosis using barbed sutures compared to conventional sutures under high, long-term pressure; in vitro extracorporeal circulation setup. Perfusion. 2024 Apr;39(3):571-577. doi: 10.1177/02676591231153539. Epub 2023 Jan 24.

    PubMed 36691745

  • Lin Y, Lai S, Huang J, Du L. The Efficacy and Safety of Knotless Barbed Sutures in the Surgical Field: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Sci Rep. 2016 Mar 23;6:23425. doi: 10.1038/srep23425.

    PubMed 27005688

  • Greenberg JA, Goldman RH. Barbed suture: a review of the technology and clinical uses in obstetrics and gynecology. Rev Obstet Gynecol. 2013;6(3-4):107-15.

    PubMed 24920976

  • Singh K, Anderson E, Harper JG. Overview and management of sternal wound infection. Semin Plast Surg. 2011 Feb;25(1):25-33. doi: 10.1055/s-0031-1275168.

    PubMed 22294940

  • Song Y, Chu W, Sun J, Liu X, Zhu H, Yu H, Shen C. Review on risk factors, classification, and treatment of sternal wound infection. J Cardiothorac Surg. 2023 May 19;18(1):184. doi: 10.1186/s13019-023-02228-y.

    PubMed 37208736

  • Reser D, Caliskan E, Tolboom H, Guidotti A, Maisano F. Median sternotomy. Multimed Man Cardiothorac Surg. 2015 Jul 17;2015:mmv017. doi: 10.1093/mmcts/mmv017. Print 2015.

    PubMed 26188337

  • Canada, P. H. A. of. Heart Disease in Canada. https://www.canada.ca/en/publichealth/services/publications/diseases-conditions/heart-disease-canada.html (2017).

  • Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, Lavie C, Lloyd-Jones D, Lu HS, Mirijello A, Temesgen AM, Mokdad A, Moran AE, Muntner P, Narula J, Neal B, Ntsekhe M, Moraes de Oliveira G, Otto C, Owolabi M, Pratt M, Rajagopalan S, Reitsma M, Ribeiro ALP, Rigotti N, Rodgers A, Sable C, Shakil S, Sliwa-Hahnle K, Stark B, Sundstrom J, Timpel P, Tleyjeh IM, Valgimigli M, Vos T, Whelton PK, Yacoub M, Zuhlke L, Murray C, Fuster V; GBD-NHLBI-JACC Global Burden of Cardiovascular Diseases Writing Group. Global Burden of Cardiovascular Diseases and Risk Factors, 1990-2019: Update From the GBD 2019 Study. J Am Coll Cardiol. 2020 Dec 22;76(25):2982-3021. doi: 10.1016/j.jacc.2020.11.010.

    PubMed 33309175

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Knotless Barbed Sutures and Mesh-based Topical Skin Adhesive in people with Cardiovascular Disease and Surgical Site Infection, run by Unity Health Toronto.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Sternal Wound Complications (Composite Endpoint) (time frame: 6 weeks post-operatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07507409, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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