Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery (NCT06918496) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prophylactic Suture Line Sealing With NE'X Glue R-eco in Cardiac and Vascular Surgery
Belgium, Poland60 participantsStarted 2025-06-30
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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., intr…
What they're measuring
1
Evaluate immediate suture line sealing using NE'X Glue R-eco.
Timeframe: From index-procedure until end of participation in the study at 3 months