Hemopatch Performance Evaluation: A Prospective Observational Registry
- Conditions
- Dura Mater Nick Cut or TearHemostatisAir LeakageBody Fluid Leakage
- Interventions
- Device: Hemopatch
- Registration Number
- NCT03392662
- Lead Sponsor
- Baxter Healthcare Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 621
-
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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hemopatch Sealant Use with General Surgery Hemopatch - Hemopatch Sealant Use with Cardiovascular Surgery Hemopatch - Hemopatch Sealant Use with Hepatobiliary Surgery Hemopatch - Hemopatch Sealant Use with Neurological/Spinal Surgery Hemopatch - Hemopatch Sealant Use with Lung Surgery Hemopatch - Hemopatch Sealant Use with Urologic Surgery Hemopatch -
- Primary Outcome Measures
Name Time Method Number of patients with related Adverse Events Up to 4 weeks (postoperative) Number of patients with postoperative pancreatic fistulas after hepatobiliary surgery Up to 4 weeks (postoperative) 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) 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
Tight closure achieved in dura mater at time of surgical closure Day 1 (intraoperative) No leak after inspection per local standard of care
Absence of air leak in lung at time of surgical closure Day 1 (intraoperative) Percentage of patients achieving hemostasis without re-bleeding at the time of surgical closure Day 1 (intraoperative) 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) Percentage of patients achieving hemostasis after 2 minutes of surgery Day 1 (up to 2 minutes postoperative)
- Secondary Outcome Measures
Name Time Method 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) Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure.
Assessment of product tissue adherence 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.
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.
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.
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) Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure.
Trial Locations
- Locations (15)
Innsbruck Universitaetsklinik
🇦🇹Innsbruck, Austria
Fakultní nemocnice u sv. Anny v Brně
🇨🇿Brno, Czechia
Krajská Nemocnice Liberec
🇨🇿Liberec, Czechia
Marien-Krankenhaus Bergisch Gladbach
🇩🇪Bergisch Gladbach, Germany
Deutsches Herzzentrum Berlin
🇩🇪Berlin, Germany
Thomayerova Nemocnice
🇨🇿Praha 4, Czechia
ASKLEPIOS Klinik St. Georg
🇩🇪Hamburg, Germany
Hospital de Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Universitari de Girona Doctor Josep Trueta
🇪🇸Girona, Spain
Universitaetsklinikum Regensburg
🇩🇪Regensburg, Germany
Azienda Ospedaliero-Universitaria Careggi
🇮🇹Firenze, Italy
Hospital General Universitario Gregorio Marañón
🇪🇸Madrid, Spain
Hospital La Paz
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Fakultní Nemocnice Ostrava
🇨🇿Ostrava, Czechia