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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
Sponsor:
Collaborator:
Guangzhou Women and Children's Medical Center
Information provided by (Responsible Party):
Jia Weijuan, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2013
Estimated Primary Completion Date : November 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Collagen

Arms and Interventions
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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
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Primary Outcome Measures :
  1. postoperative drainage magnitude [ Time Frame: up to 1 year ]

Secondary Outcome Measures :
  1. Duration of the drainage [ Time Frame: up to 1 year ]

Other Outcome Measures:
  1. The complications of seroma formation [ Time Frame: up to 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158299


Contacts
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Contact: Jia Wei juan +86-20-34071157 13560328074@163.com

Locations
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China, Guangdong
Sun Yat-sen Memorial Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510260
Contact: Zhao Jing hua    +86-13560328074    jinghua87@163.com   
Sub-Investigator: Zhao Jing hua         
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou Women and Children's Medical Center
Investigators
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Principal Investigator: Jia Wei juan Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
More Information
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Responsible Party: Jia Weijuan, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT02158299    
Other Study ID Numbers: Clinical trail003
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: June 6, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes