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

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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02158299
Study type Interventional
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Jia Wei juan
Phone +86-20-34071157
Email 13560328074@163.com
Status Recruiting
Phase Phase 4
Start date October 2013
View Details
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