Health TrialsbyHealthPanel

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

ConditionsAortic AneurysmAortic Aneurysm AbdominalValve Stenoses, AorticValve Regurgitation, MitralValve Regurgitation, TricuspidAneurysm of Ascending AortaAneurysm AbdominalArtery Diseases, PeripheralVentricular AneurysmCoronary Artery DiseaseValve Aortic RegurgitationAortic Aneurysms ArchAortic Aneurysms DescendingAortic Aneurysms Thoracoabdominal
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorGrena Biomed Limited

About this trial

This clinical study aims to evaluate the effectiveness and safety of using NE'X Glue R-eco to seal suture lines. The adhesive will be applied to reduce the risk of suture line bleeding in cardiac or vascular repair surgeries, a prosthetic or biologic graft, patch, or allograft.

The effectiveness of the adhesive will be assessed after restoring blood flow.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Surgical placement of a prosthetic or biologic graft (patch), or an allograft for cardiac and (cardio)vascular repair.

    Device

    Suture line bleeding in cardiac and vascular reconstruction poses significant risks, including morbidity, mortality, and complications related to blood loss and transfusion. Advances in surgical techniques have improved hemostasis but may not suffice, especially in patients on anticoagulant or antiplatelet medications or those using synthetic graft materials. Surgical adhesives are valuable adjuncts to standard hemostatic techniques, aiming to prevent postoperative bleeding and its associated complications. NE'X Glue R-eco, a novel surgical adhesive, utilizes recombinant human serum albumin (rHSA) and glutaraldehyde (GA) for suture line sealing. It is similar to BioGlue®, which uses bovine serum albumin (BSA) and GA, and has proven safety and benefits. Distinguishing Features of NE'X Glue R-eco: Composition: Uses rHSA expressed in plants, offering improved biocompatibility and reduced risk of allergic reactions. Bonding Strength: Demonstrates high bonding strength in tests, comparab

Treatment groups

60 Participants
are divided into 1 treatment group
Group A: Single-armExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate immediate suture line sealing using NE'X Glue R-eco.

Proportion of patients/anastomoses with immediate suture line sealing by NE'X Glue R-eco, evidenced by lack of clinically significant bleeding (bleeding status is 'No bleeding' or 'Oozing'), as judged by the surgeon immediately after clamp release. Clamp release is performed 2 minutes after the application of the adhesive. Bleeding is classified into one of four categories: 1. No bleeding, 2. Oozing, 3. Fast flow, 4. Spurting, where 1 and 2 will be considered as 'no clinically significant bleeding' and 3 and 4 as 'bleeding'. Sealing time refers to the time the anastomotic site is completely sealed, that is, the last time point in which bleeding status equaled 'No bleeding' and 'Oozing'. Immediate sealing means the sealing time is 0. For patients with multiple anastomoses, immediate suture line sealing should occur in all for the patient to have no clinically significant bleeding at sealing time 0.

Time frame
From index-procedure until end of participation in the study at 3 months

Secondary outcomes

1

To determine the proportion of patients/anastomoses with suture line sealing using NE'X Glue R-eco, measured at 1, 3, 5, and 10 minutes after clamp release (timed with a calibrated stop watch).

The cases where the investigator choses to intervene and use additional methods to achieve hemostasis will be defined as 'bleeding'. For patients with more than one anastomotic site treated, the site with the longest time to hemostasis was used for these analyses. If fast flow or spurting, the surgeon may use additional agents for hemostasis before the 10 minutes are up to guarantee the safety of the patient.

Time frame
During the index-procedure
2

To determine the elapsed time from clamp release to hemostasis (sealing time) recorded per site.

Sealing time refers to the time the anastomotic site is completely sealed, that is, the last time point in which bleeding status equaled 'No bleeding' and 'Oozing'. Anastomoses where the investigator choses to intervene and use additional methods to achieve hemostasis will not be included in this analysis. Any time to hemostasis that was \>10 minutes was treated as 10 minutes in the analysis.

Time frame
During the index-procedure
3

To determine the use of any additional methods to achieve hemostasis (including pledgets, sutures, hemostatic devices, antifibrinolytic agents, thrombin glues, fibrin glues, etc.) (type and quantity).

For patients with more than one anastomotic site treated, each patient will be classified as having had an additional agent or not.

Time frame
During the index-procedure
4

To determine the product handling and performance of NE'X Glue R-eco

By documenting the following outcomes, using the following four possible responses: excellent, good, fair or poor. * Ease of preparing * Performance of the delivery system * Gel rate * Adhesiveness

Time frame
During the index-procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grena Biomed Limited

Lead sponsor

Archer Research

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: