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

Primary Purpose

Drainage, Postoperative Complications

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Avitene
Sapylin
axillary drainage
reexamine
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Drainage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Avitene,Drainaging,reexamine

Sapylin,Drainaging,reexamine

Drainaging,reexamine

Arm Description

Outcomes

Primary Outcome Measures

postoperative drainage magnitude

Secondary Outcome Measures

Duration of the drainage

Full Information

First Posted
May 22, 2014
Last Updated
June 4, 2014
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Guangzhou Women and Children's Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02158299
Brief Title
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

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
November 2014 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborators
Guangzhou Women and Children's Medical Center

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drainage, Postoperative Complications

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
3 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Avitene,Drainaging,reexamine
Arm Type
Experimental
Arm Title
Sapylin,Drainaging,reexamine
Arm Type
Experimental
Arm Title
Drainaging,reexamine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Avitene
Intervention Type
Drug
Intervention Name(s)
Sapylin
Intervention Type
Behavioral
Intervention Name(s)
axillary drainage
Intervention Type
Other
Intervention Name(s)
reexamine
Primary Outcome Measure Information:
Title
postoperative drainage magnitude
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
Duration of the drainage
Time Frame
up to 1 year
Other Pre-specified Outcome Measures:
Title
The complications of seroma formation
Time Frame
up to 1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients volunteered for the study and signed informed consent； Preoperative biopsy or intraoperative sentinel lymph node biopsy confirmed axillary lymph node metastasis and need axillary lymphadenectomy No penicillin allergy No blood system diseases No rheumatic heart disease No history or family history of asthma No history of axillary surgery Exclusion Criteria: A history of severe hypertension A history of diabetes Undergoing anticoagulant therapy or anticoagulant therapy drug withdrawal less than a year BMI>30 Can not accept telephone follow-up or can not go to the hospital for subsequent inspection treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jia Wei juan
Phone
+86-20-34071157
Email
13560328074@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jia Wei juan
Organizational Affiliation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510260
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Jing hua
Phone
+86-13560328074
Email
jinghua87@163.com
First Name & Middle Initial & Last Name & Degree
Zhao Jing hua

12. IPD Sharing Statement

Learn more about this trial

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

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