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

• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02158299
• Collaborator: Guangzhou Women and Children's Medical Center (Other)
• Enrollment: 3
• Location: 1
• Arms: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Drainage; Postoperative Complications	Drug: Avitene; Drug: Sapylin; Behavioral: axillary drainage; Other: reexamine	Phase 4

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 3 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Primary Purpose: Treatment
• 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 Start Date: Oct 1, 2013
• Anticipated Primary Completion Date: Nov 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Avitene,Drainaging,reexamine	Drug: Avitene; Behavioral: axillary drainage; Other: reexamine
Experimental: Sapylin,Drainaging,reexamine	Drug: Sapylin; Behavioral: axillary drainage; Other: reexamine
Active Comparator: Drainaging,reexamine	Behavioral: axillary drainage; Other: reexamine

Outcome Measures

Primary Outcome Measures

1. postoperative drainage magnitude [up to 1 year]

Secondary Outcome Measures

1. Duration of the drainage [up to 1 year]

Other Outcome Measures

1. The complications of seroma formation [up to 1 year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong	China	510260

Sponsors and Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Guangzhou Women and Children's Medical Center

Investigators

• Principal Investigator: Jia Wei juan, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jia Weijuan, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• ClinicalTrials.gov Identifier: NCT02158299
• Other Study ID Numbers: Clinical trail003
• First Posted: Jun 6, 2014
• Last Update Posted: Jun 6, 2014
• Last Verified: Jun 1, 2014

• Additional relevant MeSH terms: Postoperative Complications

Study Results

No Results Posted as of Jun 6, 2014