soft tissue hemostasis
Conditions
Interventions
Test group:Borayflo hemostatic fluid gelatin matrix was given to assist hemostasis during operation.
Control group:Surgiflo hemostatic fluid gelatin matrix was given to assist hemostasis during operation.
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) The subjects were 75 years old (including 18 and 75 years old), regardless of gender. (2) To undergo hepatobiliary surgery, gynecological or orthopedic surgery. (3) According to the judgment of clinical symptoms and vital signs and combined with the results of laboratory examination, the researchers considered that there was no active bleeding (active bleeding refers to visceral or intracranial bleeding, that is, the process of continuous leakage of blood from diseased blood vessels within a certain period of time). (4) Voluntarily sign an informed consent form, understand and accept the duration of the study, and be able and willing to comply with all requirements, including planned treatment, follow-up and other research procedures.
Exclusion criteria
Exclusion criteria: (1) An active infection or a local surgical site infection that may have an impact on hemostasis; (2) Coagulation or bleeding disorders characterized by a = 20% increase in prothrombin time (PT), activated partial thromboplastin time (APTT), or other coagulation indexes compared to the normal reference range; (3) Pregnancy or lactation status; (4) Recent utilization of platelet receptor antagonists within 48 hours prior to the surgical procedure; (5) Documented allergy to porcine gelatin; (6) Involvement in drug clinical trials or clinical trials of other medical devices within the preceding 3 months. (7) Participation in this clinical study is considered inappropriate by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effective rates of hemostasis at 5 min; | — |
Secondary
| Measure | Time frame |
|---|---|
| Intraoperative hemostatic time of wound;Procedure time;The change in RBC counts from preoperative level;The change in hemoglobin from preoperative level;Intraoperative blood transfusion volume;Intraoperative bleeding volume; | — |
Countries
China
Contacts
Public ContactZhiying Yang
China-Japan Friendship Hospital
Outcome results
None listed