Clinical trial NCT02158299: Contrast The Role of Avitene And OK-432 in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Drainage
Postoperative Complications
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Guangzhou Women and Children's Medical Center
First posted: 2014-06-06
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: postoperative drainage magnitude
timeFrame: up to 1 year
Secondary outcomes:
measure: Duration of the drainage
timeFrame: up to 1 year
Other outcomes:
measure: The complications of seroma formation
timeFrame: up to 1 year
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jia Wei juan
role: PRINCIPAL_INVESTIGATOR
References: