Drainage, Postoperative Complications
Conditions
Brief summary
After Axillary lymphadenectomy for breast cancer there are not few patients showed seroma formation and it can not be ignored.Investigators aimed to study two new methods of application of Microfibrillar Collagen Hemostat Flour and OK-432 to reduce seroma formation and to verify the efficacy and safety of these two applications.Try to prove them as beneficial supplements for axillary lymphadenectomy of breast cancer.
Detailed description
A prospective,randomized analysis of breast-conserving surgery or mastectomy plus axillary lymphadenectomy for those patients with sentinel node positive using Microfibrillar Collagen Hemostat Flour 、 OK-432 or using nothing in equal probability.Up to 12 months,a total of 180 will be recruited in plan.During the operation and after the axillary lymphadenectomy，according the arms，Investigators put Microfibrillar Collagen Hemostat Flour（avitene）、 OK-432（Sapylin） or nothing into patients axillary wounds。And Investigators will the statistical significance of these three arms that the postoperative drainage magnitude and duration.Also the complications associated with axillary lymphadenectomy will be studied.
Interventions
Sponsors
Guangzhou Women and Children's Medical Center
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients volunteered for the study and signed informed consent； 2. Preoperative biopsy or intraoperative sentinel lymph node biopsy confirmed axillary lymph node metastasis and need axillary lymphadenectomy 3. No penicillin allergy 4. No blood system diseases 5. No rheumatic heart disease 6. No history or family history of asthma 7. No history of axillary surgery
Exclusion criteria
1. A history of severe hypertension 2. A history of diabetes 3. Undergoing anticoagulant therapy or anticoagulant therapy drug withdrawal less than a year 4. BMI\>30 5. Can not accept telephone follow-up or can not go to the hospital for subsequent inspection treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| postoperative drainage magnitude | up to 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Duration of the drainage | up to 1 year |
Other
| Measure | Time frame |
|---|---|
| The complications of seroma formation | up to 1 year |
Countries
China
Contacts
Primary ContactJia Wei juan
Outcome results
None listed