Contrast The Role of Avitene And OK-432 in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer
Contrast The Role of Microfibrillar Collagen Hemostat Flour（Avitene） And OK-432 （Sapylin）in Reducing Seroma Formation After Axillary Lymphadenectomy for Breast Cancer
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 22, 2014
CompletedFirst Posted
Study publicly available on registry
June 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2014
CompletedJune 6, 2014
June 1, 2014
1.1 years
May 22, 2014
June 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative drainage magnitude
up to 1 year
Secondary Outcomes (1)
Duration of the drainage
up to 1 year
Other Outcomes (1)
The complications of seroma formation
up to 1 year
Study Arms (3)
Avitene,Drainaging,reexamine
EXPERIMENTALSapylin,Drainaging,reexamine
EXPERIMENTALDrainaging,reexamine
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510260, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jia Wei juan
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study Record Dates
First Submitted
May 22, 2014
First Posted
June 6, 2014
Study Start
October 1, 2013
Primary Completion
November 1, 2014
Last Updated
June 6, 2014
Record last verified: 2014-06