Contrast The Role of Avitene And OK-432 in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer
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ClinicalTrials.gov Identifier: NCT02158299
Recruitment Status : Unknown
Verified June 2014 by Jia Weijuan, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruitment status was: Recruiting
First Posted : June 6, 2014
Last Update Posted : June 6, 2014
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou Women and Children's Medical Center
Information provided by (Responsible Party):
Jia Weijuan, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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.
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.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
A history of severe hypertension
A history of diabetes
Undergoing anticoagulant therapy or anticoagulant therapy drug withdrawal less than a year
Can not accept telephone follow-up or can not go to the hospital for subsequent inspection treatment