Benign breast nodules
Conditions
Interventions
Experimental group:recombinant human thrombin (Zepun)
Control group:Normal saline
Sponsors
The Women's Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18-60 years; 2. Breast nodules detected by breast ultrasound (BI-RADS category 2, 3, or 4a); 3. Undergoing minimally invasive breast nodule excision (single nodule or multiple nodules, with one nodule designated as the observation index); 4. Normal coagulation function indicators (including PLT, PT, APTT, etc.), and no history of coagulation disorders (such as hemophilia); 5. Signed informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with coagulation disorders or currently using anticoagulants (such as warfarin); 2. Patients with a history of thrombosis; 3. Pregnant or lactating women; 4. Malignant breast cancer; 5. Patients with severe cardiovascular disease or severe hepatic or renal insufficiency; 6. Patients with mental illness or cognitive impairment; 7. Patients lost to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bleeding in the surgical area;Incidence of bleeding;Coagulation function indicators;Incidence of hematoma; | — |
Secondary
| Measure | Time frame |
|---|---|
| Allergic reactions, thrombotic events, and incision infection rates; | — |
Countries
China
Contacts
Public ContactJingpei Long
The Women's Hospital, Zhejiang University School of Medicine
Outcome results
None listed