Hemopatch Performance Evaluation: A Prospective Observational Registry
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dura Mater Nick Cut or Tear
- Sponsor
- Baxter Healthcare Corporation
- Enrollment
- 621
- Locations
- 15
- Primary Endpoint
- Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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:
- •Hepato-biliary (liver, pancreas, gallbladder)
- •General surgery (in thyroid and other regions)
- •Cardiovascular (heart and vessels)
- •thoracic (lung and mediastinum)
- •Urological (kidney, prostate, and bladder
- •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
Outcomes
Primary Outcomes
Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery
Time Frame: Up to 4 weeks (postoperative)
Number of patients with related Adverse Events
Time Frame: Up to 4 weeks (postoperative)
Number of patients with chest tube drainage >=5 days after thoracic/lung surgery
Time Frame: Day 5 up to 4 weeks (postoperative)
Number of patients needing reinsertion of chest tube for pneumothorax after thoracic/lung surgery
Time Frame: Up to 4 weeks (postoperative)
Duration of bile leakage after hepatobiliary surgery
Time Frame: Up to 4 weeks (postoperative)
Number of patients with postoperative cerebrospinal fluid (CSF) leakage after neurological surgery
Time Frame: Up to 4 weeks (postoperative)
External or internal accumulation including pseudomeningocele
Tight closure achieved in dura mater at time of surgical closure
Time Frame: Day 1 (intraoperative)
No leak after inspection per local standard of care
Percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure
Time Frame: Day 1 (intraoperative)
Absence of air leak in lung at time of surgical closure
Time Frame: Day 1 (intraoperative)
Number of patients with postoperative urinary fistula formation after urological surgery
Time Frame: Up to 4 weeks (postoperative)
Gastrointestinal anastomosis leakage/fistula after general surgery
Time Frame: Up to 4 weeks (postoperative)
Percentage of patients achieving hemostasis after 2 minutes of surgery
Time Frame: Day 1 (up to 2 minutes postoperative)
Secondary Outcomes
- Number of Hemopatch units applied(Up to 4 weeks (postoperative))
- Number of intraoperative transfusions by type and amount of blood product transfused(Day 1 (intraoperative))
- Assessment of product tissue adherence(Day 1 (intraoperative))
- Product characteristics liked least by Surgeon(Day 1 (intraoperative))
- Surgery duration(Day 1 (intraoperative))
- Length of hospital stay(Up to 4 weeks (postoperative))
- Ease of product preparation(Day 1 (intraoperative))
- Ease of product handling(Day 1 (intraoperative))
- Surgeon's overall satisfaction of product(Day 1 (intraoperative))
- Product characteristics appreciated by Surgeon(Day 1 (intraoperative))
- Surgical revisions/reoperations due to bleeding, air, or other body fluid leakage(Up to 4 weeks (postoperative))
- Number of postoperative transfusions by type and amount of blood product transfused up to 72 hours after surgery(Up to 72 hours (postoperative))