Contrast The Role of Avitene And OK-432 in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Contrast The Role of Microfibrillar Collagen Hemostat Flour（Avitene） And OK-432 （Sapylin）in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer

Conditions
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Drainage, Postoperative Complications

Intervention / Treatment
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* Drug: Avitene
* Drug: Sapylin
* Behavioral: axillary drainage
* Other: reexamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients volunteered for the study and signed informed consent； Preoperative biopsy or intraoperative sentinel lymph node biopsy confirmed axillary lymph node metastasis and need axillary lymphadenectomy No penicillin allergy No blood system diseases No rheumatic heart disease No history or family history of asthma No history of axillary surgery Exclusion Criteria: A history of severe hypertension A history of diabetes Undergoing anticoagulant therapy or anticoagulant therapy drug withdrawal less than a year BMI>30 Can not accept telephone follow-up or can not go to the hospital for subsequent inspection treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avitene,Drainaging,reexamine<br> | Drug: Avitene<br> <br> Behavioral: axillary drainage<br> <br> Other: reexamine<br> <br> |
| Experimental: Sapylin,Drainaging,reexamine<br> | Drug: Sapylin<br> <br> Behavioral: axillary drainage<br> <br> Other: reexamine<br> <br> |
| Active Comparator: Drainaging,reexamine<br> | Behavioral: axillary drainage<br> <br> Other: reexamine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative drainage magnitude |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the drainage |  | up to 1 year |