Hemopatch Performance Evaluation: A Prospective Observational Registry

Baxter Healthcare Corporation621 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

621

Conditions

Dura Mater Nick Cut or Tear Hemostatis Air Leakage Body Fluid Leakage

Interventions

HemopatchDEVICE

Patients received product at the discretion of their surgeon.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (15)

Innsbruck Universitaetsklinik

Innsbruck, Austria

Fakultní nemocnice u sv. Anny v Brně

Brno, Czechia

Krajská Nemocnice Liberec

Liberec, Czechia

Outcomes

Primary Outcomes

Percentage of patients achieving hemostasis after 2 minutes of surgery

Time frame: Day 1 (up to 2 minutes postoperative)

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)

Tight closure achieved in dura mater at time of surgical closure

No leak after inspection per local standard of care

Time frame: Day 1 (intraoperative)

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)

Number of patients with postoperative pancreatic fistulas after hepatobiliary 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

External or internal accumulation including pseudomeningocele

Time frame: Up to 4 weeks (postoperative)

Number of patients with postoperative urinary fistula formation after urological surgery

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Secondary Outcomes

Number of Hemopatch units applied

Time frame: Up to 4 weeks (postoperative)

Surgical revisions/reoperations due to bleeding, air, or other body fluid leakage

Time frame: Up to 4 weeks (postoperative)

Number of intraoperative transfusions by type and amount of blood product transfused

Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure.

Time frame: Day 1 (intraoperative)

Number of postoperative transfusions by type and amount of blood product transfused up to 72 hours after surgery

Unit of measure will be number of transfusion procedures and will be summarized as a single outcome measure.

Time frame: Up to 72 hours (postoperative)

Surgery duration

Time frame: Day 1 (intraoperative)

Length of hospital stay

Intensive Care Unit (ICU) and hospital

Time frame: Up to 4 weeks (postoperative)

Ease of product preparation

Surgeon's overall product assessment and satisfaction recorded on questionnaire.

Time frame: Day 1 (intraoperative)

Ease of product handling

Surgeon's overall product assessment and satisfaction recorded on questionnaire.

Time frame: Day 1 (intraoperative)

Assessment of product tissue adherence

Surgeon's overall product assessment and satisfaction recorded on questionnaire.

Time frame: Day 1 (intraoperative)

Surgeon's overall satisfaction of product

Surgeon's overall product assessment and satisfaction recorded on questionnaire.

Time frame: Day 1 (intraoperative)

Product characteristics appreciated by Surgeon

Surgeon's overall product assessment and satisfaction recorded on questionnaire.

Time frame: Day 1 (intraoperative)

Product characteristics liked least by Surgeon

Surgeon's overall product assessment and satisfaction recorded on questionnaire.

Time frame: Day 1 (intraoperative)