Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients
New breastbone closure methods tested after heart bypass surgery
Plain English Summary
Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients is a Phase 4 clinical trial sponsored by Unity Health Toronto studying Cardiovascular Disease, Surgical Site Infection, Superficial Sternal Wound Infection, Mediastinitis. This trial tests new ways to close the breastbone after heart bypass surgery using special sutures and skin glue. It's for adults undergoing coronary artery bypass graft (CABG) surgery. Participation involves receiving the new closure method during surgery and follow-up visits for about 6 weeks. The alternative is the standard method of closing the breastbone with traditional stitches. The trial aims to enroll 401 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults aged 18 and older who are having heart bypass surgery can join. You cannot join if you refuse to participate, do not speak English, or have allergies to surgical glue or stitches. This trial is studying Cardiovascular Disease, Surgical Site Infection, Superficial Sternal Wound Infection, Mediastinitis, so participants generally need a confirmed diagnosis.
What They're Measuring
The main goal is to see if the new closure methods reduce problems like infections or the wound reopening within 6 weeks after surgery. The specific primary outcome measures are: Incidence of Sternal Wound Complications (Composite Endpoint) (6 weeks post-operatively). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.
Why This Trial Matters
This trial matters because it aims to find a better way to heal the breastbone after heart surgery, potentially reducing infections and wound problems. This research targets Cardiovascular Disease, Surgical Site Infection, Superficial Sternal Wound Infection, Mediastinitis, where improved treatment options are needed.
Investor Insight
This trial focuses on improving surgical outcomes for a common procedure, potentially leading to faster recovery and reduced healthcare costs, which is attractive to investors. This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.
Is This Trial Right for Me?
Ask your doctor about the new closure methods and how they might affect your recovery. You will receive the new closure method during your surgery and have follow-up appointments to check your healing. You will be asked to complete a short questionnaire about your quality of life. The trial is being conducted at multiple sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 401 participants
Interventions
- 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 infec
- 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.
Primary Outcomes
- Incidence of Sternal Wound Complications (Composite Endpoint) (6 weeks post-operatively)
Frequently Asked Questions
What is clinical trial NCT07507409?
NCT07507409 is a Phase 4 INTERVENTIONAL study titled "Innovative Sternal Closure Techniques: Evaluating STRATAFIX™ and DERMABOND™ for Reduced Complications in CABG Patients." It is currently not yet recruiting and is sponsored by Unity Health Toronto. The trial targets enrollment of 401 participants.
What conditions does NCT07507409 study?
This trial investigates treatments for Cardiovascular Disease, Surgical Site Infection, Superficial Sternal Wound Infection, Mediastinitis. The primary condition under study is Cardiovascular Disease.
What treatments are being tested in NCT07507409?
The interventions being studied include: Knotless Barbed Sutures (DEVICE), Mesh-based Topical Skin Adhesive (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 infec
What does Phase 4 mean for NCT07507409?
Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.
What is the current status of NCT07507409?
This trial is currently "Not Yet Recruiting." It started on 2026-05-01. The estimated completion date is 2028-05-01.
Who is sponsoring NCT07507409?
NCT07507409 is sponsored by Unity Health Toronto. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07507409?
The trial aims to enroll 401 participants. The trial has not yet started recruiting.
How is NCT07507409 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT07507409?
The primary outcome measures are: Incidence of Sternal Wound Complications (Composite Endpoint) (6 weeks post-operatively). These are the main endpoints researchers use to determine whether the treatment is effective.
Where can I find official information about NCT07507409?
The official record for NCT07507409 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07507409. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07507409 testing in simple terms?
This trial tests new ways to close the breastbone after heart bypass surgery using special sutures and skin glue. It's for adults undergoing coronary artery bypass graft (CABG) surgery.
Why is this trial significant?
This trial matters because it aims to find a better way to heal the breastbone after heart surgery, potentially reducing infections and wound problems.
What are the potential risks of participating in NCT07507409?
Potential risks include allergic reactions to the surgical glue or sutures. As with any surgery, there's a risk of infection or wound reopening, though this trial aims to reduce these. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07507409?
Ask your doctor about the new closure methods and how they might affect your recovery. You will receive the new closure method during your surgery and have follow-up appointments to check your healing. You will be asked to complete a short questionnaire about your quality of life. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07507409 signal from an investment perspective?
This trial focuses on improving surgical outcomes for a common procedure, potentially leading to faster recovery and reduced healthcare costs, which is attractive to investors. This is a Phase 4 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves receiving the new closure method during surgery and follow-up visits for about 6 weeks. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.