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

Phase 4

• Conditions: Drainage; Postoperative Complications
• Interventions: Drug: Sapylin; Drug: Avitene; Behavioral: axillary drainage; Other: reexamine

• Registration Number: NCT02158299
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2014-05-22
• Status Verified: 2014-06
• Study First Submitted QC: 2014-06-04
• Last Update Submitted: 2014-06-04
• Study First Posted: 2014-06-06
• Last Update Posted: 2014-06-06
• Primary Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Avitene,Drainaging,reexamine	reexamine	-
Sapylin,Drainaging,reexamine	Sapylin	-
Avitene,Drainaging,reexamine	axillary drainage	-
Sapylin,Drainaging,reexamine	reexamine	-
Drainaging,reexamine	axillary drainage	-
Drainaging,reexamine	reexamine	-
Sapylin,Drainaging,reexamine	axillary drainage	-
Avitene,Drainaging,reexamine	Avitene	-

Primary Outcome Measures

Name	Time	Method
postoperative drainage magnitude	up to 1 year

Secondary Outcome Measures

Name	Time	Method
Duration of the drainage	up to 1 year

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China