Postoperative Complications Clinical Trial
Official title:
Contrast The Role of Microfibrillar Collagen Hemostat Flour(Avitene) And OK-432 (Sapylin)in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer
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.
Status | Recruiting |
Enrollment | 3 |
Est. completion date | |
Est. primary completion date | November 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Guangzhou Women and Children's Medical Center |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The complications of seroma formation | up to 1 year | Yes | |
Primary | postoperative drainage magnitude | up to 1 year | Yes | |
Secondary | Duration of the drainage | up to 1 year | Yes |
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