Postoperative wound bleeding in thoracic surgery
Conditions
Interventions
Treatment group:Spray-applied porcine fibrin sealant
Control group:Pressure dressing with sterile gauze
Sponsors
The Second Affiliated Hospital of Naval Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age >=18 years old, gender is not limited; 2. Voluntarily join this study, be able to complete the signed informed consent form, and have good compliance; 3. Patients with bleeding wounds after lymph node dissection, or hemorrhage wounds after thoracic adhesion separation, or hemorrhage wounds after hilum or segment hemorrhage, or lung/vessel nail margin oozing (including but not limited to lobe, lung segment, wedge resection, mediastinal tumor resection, esophageal junction tumor surgery, esophageal tumors, neoadjuvant therapy surgery) during thoracic surgery (including lobes, lung segments, wedge resection, mediastinal tumor resection), or bleeding wounds after lesion resection.
Exclusion criteria
Exclusion criteria: 1. Those who are known to be allergic to any ingredient of this variety; 2. Systemic diseases, such as severe hypertension, tuberculosis, diabetes, liver disease that is not controlled, and diseases that the investigator believes may interfere with participation in the study or evaluation; 3. Those who do not have sufficient organ and bone marrow function, such as: abnormal liver function, AST and ALT 1.5 times the upper limit of normal range in multiple hospitals, abnormal renal function blood creatinine 1.2 times the upper limit of normal, blood routine platelet (PLT) <75×10^9/L, hemoglobin < 90 g/L (no blood transfusion or no erythropoietin dependence within 14 days), etc., or those who are assessed to be intolerant to surgery; 4. Those with severe coagulation dysfunction or severe hematological diseases and other unsuitable surgical procedures; 5. Pregnant or planning to have a pregnancy plan within half a year, lactating women; 6. Patients who have participated in drug clinical trials in the previous 3 months or other device clinical trials in the previous 1 month; 7. Subjects who are considered by the investigator to be inappropriate to participate in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 4-minute hemostasis success rate ; | — |
Secondary
| Measure | Time frame |
|---|---|
| 2-minute hemostasis success rate ;6-minute hemostasis success rate ;8-minute hemostasis success rate ;10-minute hemostasis success rate ;Total postoperative drainage volume ;Rate of repeat hemostatic procedures at 10 minutes;Incidence and severity of adverse events during the entire treatment period; | — |
Countries
China
Contacts
Public ContactLei Xue
The Second Affiliated Hospital of Naval Medical University
Outcome results
None listed