Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery

Launched by GRENA BIOMED LIMITED · Apr 8, 2025

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ClinConnect Summary

This clinical trial is looking at a new type of glue called NE'X Glue R-eco, which is applied to the stitches (suture lines) used during heart and blood vessel surgeries. The main goal is to see if this glue can help prevent bleeding from the areas where the stitches are placed, especially when doctors are using grafts (tissue used to replace or repair damaged blood vessels). This study will assess how well the glue works after the surgery restores blood flow to the area.

To participate in this trial, patients need to be at least 18 years old and scheduled for specific types of surgeries that involve placing grafts for heart or vascular repairs. Patients who are currently on blood thinners or have certain medical conditions may still qualify, but those with specific allergies, active infections, or other health concerns might not be eligible. If you join the study, you’ll be asked to follow up for about three months after your surgery. It's important to know that this study is not yet recruiting participants, so more details will be available when it starts.

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Eligibility criteria

• Inclusion Criteria:
• • Patient ≥ 18 years of age at study entry.
• • Patient is scheduled for open procedures for surgical placement of a prosthetic or biologic graft (patch) or an allograft for cardiac and (cardio)vascular anastomosis repair. Emergency, transplantation and minimally invasive procedures are excluded. Patients receiving long-term anticoagulation, including antiplatelet agent, are included. Choice of graft is at the discretion of the surgeon.
• • Patient is willing and able to be contacted for up to 3 months (± 14 days) follow-up.
• • Patient or legal representative and investigator signed and dated the informed consent form prior to the index-procedure.
• Exclusion Criteria:
• • Patient has a known hypersensitivity, contraindication, or allergic reaction to albumin or glutaraldehyde.
• • Patient has a history of bleeding diathesis or coagulopathy.
• • Presence of active infection or contamination in the to be grafted area or the vicinity.
• • Known vasculitis in the to be grafted area.
• • Patient takes immune suppressive medication like prednisone resulting in weakening of the vessel wall.
• • Patient is refusing blood transfusion.
• • Patient or legal representative is unable / unwilling to provide informed consent.
• • Patient is unable to comply with the protocol or proposed follow-up visits.
• • Female patient is pregnant, lactating, or planning pregnancy during the clinical investigation.
• • Female participants of childbearing age must agree to use safe contraception (e.g., intrauterine devices, hormonal contraceptives: contraceptive pills, implants, transdermal patches hormonal vaginal devices, injections with prolonged release, abstinence).
• • Patients who are currently enrolled in another clinical study, or have recently participated in a clinical study, that could potentially interfere with the outcomes or introduce bias into the results of the current study (as determined by the investigator). This includes studies involving investigational drugs, medical devices, or other interventions that could impact the safety, efficacy, or scientific integrity of this study.