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

NANot yet recruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Aortic 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
Interventions
DEVICE

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

"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"

Trial Locations (2)

3500

Jessa Hospital, Hasselt

04-628

Klinika Kardiochirurgii i Transplantologii, Warsaw

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Archer Research

INDUSTRY

lead

Grena Biomed Limited

INDUSTRY

NCT06918496 - Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery | Biotech Hunter | Biotech Hunter