Hemopatch Performance Evaluation: A Prospective Observational Registry

Baxter

Status

Completed

Conditions

Hemostatis

Dura Mater Nick Cut or Tear

Air Leakage

Body Fluid Leakage

Treatments

Device: Hemopatch

Study type

Observational

Funder types

Industry

Identifiers

NCT03392662

BXU011443

Details and patient eligibility

About

To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.

Enrollment

621 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Male or female patients of any age
Patients who had undergone open or minimal invasive surgical (MIS) procedures requiring the use of a patch to achieve dura repair, hemostasis, or control of leakage of air or other body fluid when pressure, ligature or other conventional procedures had been ineffective or impractical and where use of hemopatch was deemed appropriate by the surgeon according to its IFU in the following organ systems:
1. Hepato-biliary (liver, pancreas, gallbladder)
2. General surgery (in thyroid and other regions)
3. Cardiovascular (heart and vessels)
4. thoracic (lung and mediastinum)
5. Urological (kidney, prostate, and bladder
6. Neurological (dura mater, brain and spinal cord)
Provision of written informed consent/assent, as applicable, up to 72 hours after the date of surgery

Exclusion criteria

Patients with known hypersensitivity to bovine proteins or brilliant blue
Patients who had intraoperative pulsatile or severe bleeding at the target application site (TAS)
Patients who had an active infection at the TAS