None listed
Conditions
Interventions
Medical Device : This clinical study is a multi-center, randomized, single-blind (investigational subjects), non-inferiority confirmatory clinical study to compare the hemostatic effect of CollaStat®,
Sponsors
Yonsei University Health System, Severance Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? One who voluntarily signed and sealed the Written Consent for participating in the research as a trial subject ? Patient aged over 20 ? Patient who can participate in the research during the entire period of clinical trial ? Patient scheduled to have spinal surgery due to spinal stenosis, spinal tumor, injury, etc. ? Patients who have difficulty managing hemostasis using existing standard procedures ? Patients with grade 3 or higher bleeding * Grade 4 or 5 bleeding is reduced to grade 3 by normal procedures (compression, sutures, electrosurgical scalpel, etc.).
Exclusion criteria
Exclusion criteria: ? Pregnant woman or any woman who will be pregnant within 1 month after applying collagen-based hemostat ? One who is hypersensitive to bovine or porcine- derived materials ? Others whom investigators regard as inappropriate for participating in the research ? Patients who are using treatments that may affect the test results ? Patients with active infections at the surgical site ? Patients who are contraindicated for the use of local hemostatic material
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hemostasis success rate | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to hemostasis;Number of hemostats used;Hospital stay;Incidence of adverse events such as Hematoma and Infection;Drain amount;Presence or absence of intraoperative rebleeding at the first bleeding site;Hemostasis effect of all bleeding sites using hemostatic material | — |
Countries
Korea, Republic of
Contacts
Public ContactBoyeon Ko
Yonsei University Health System, Severance Hospital
Outcome results
None listed