Dura Mater Nick Cut or Tear, Hemostatis, Air Leakage, Body Fluid Leakage
Conditions
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.
Interventions
DEVICEHemopatch
Patients received product at the discretion of their surgeon.
Sponsors
Baxter Healthcare Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with related Adverse Events | Up to 4 weeks (postoperative) | — |
| Percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure | Day 1 (intraoperative) | — |
| Percentage of patients achieving hemostasis after 2 minutes of surgery | Day 1 (up to 2 minutes postoperative) | — |
| Absence of air leak in lung at time of surgical closure | Day 1 (intraoperative) | — |
| Tight closure achieved in dura mater at time of surgical closure | Day 1 (intraoperative) | No leak after inspection per local standard of care |
| Number of patients with chest tube drainage >=5 days after thoracic/lung surgery | Day 5 up to 4 weeks (postoperative) | — |
| Number of patients needing reinsertion of chest tube for pneumothorax after thoracic/lung surgery | Up to 4 weeks (postoperative) | — |
| Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery | Up to 4 weeks (postoperative) | — |
| Duration of bile leakage after hepatobiliary surgery | Up to 4 weeks (postoperative) | — |
| Number of patients with postoperative cerebrospinal fluid (CSF) leakage after neurological surgery | Up to 4 weeks (postoperative) | External or internal accumulation including pseudomeningocele |
| Number of patients with postoperative urinary fistula formation after urological surgery | Up to 4 weeks (postoperative) | — |
| Gastrointestinal anastomosis leakage/fistula after general surgery | Up to 4 weeks (postoperative) | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hemopatch units applied | Up to 4 weeks (postoperative) | — |
| Surgical revisions/reoperations due to bleeding, air, or other body fluid leakage | Up to 4 weeks (postoperative) | — |
| Number of intraoperative transfusions by type and amount of blood product transfused | Day 1 (intraoperative) | Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure. |
| Number of postoperative transfusions by type and amount of blood product transfused up to 72 hours after surgery | Up to 72 hours (postoperative) | Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure. |
| Surgery duration | Day 1 (intraoperative) | — |
| Length of hospital stay | Up to 4 weeks (postoperative) | Intensive Care Unit (ICU) and hospital |
| Ease of product preparation | Day 1 (intraoperative) | Surgeon's overall product assessment and satisfaction recorded on questionnaire. |
| Ease of product handling | Day 1 (intraoperative) | Surgeon's overall product assessment and satisfaction recorded on questionnaire. |
| Assessment of product tissue adherence | Day 1 (intraoperative) | Surgeon's overall product assessment and satisfaction recorded on questionnaire. |
| Surgeon's overall satisfaction of product | Day 1 (intraoperative) | Surgeon's overall product assessment and satisfaction recorded on questionnaire. |
| Product characteristics appreciated by Surgeon | Day 1 (intraoperative) | Surgeon's overall product assessment and satisfaction recorded on questionnaire. |
| Product characteristics liked least by Surgeon | Day 1 (intraoperative) | Surgeon's overall product assessment and satisfaction recorded on questionnaire. |
Countries
Austria, Czechia, Germany, Italy, Spain
Outcome results
None listed