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| Name | Class |
|---|---|
| Guangzhou Women and Children's Medical Center | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Avitene,Drainaging,reexamine | Experimental |
| |
| Sapylin,Drainaging,reexamine | Experimental |
| |
| Drainaging,reexamine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avitene | Drug |
| ||
| Sapylin |
| Measure | Description | Time Frame |
|---|---|---|
| postoperative drainage magnitude | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of the drainage | up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The complications of seroma formation | up to 1 year |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Wei juan | Contact | +86-20-34071157 | 13560328074@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Wei juan | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen Memorial Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510260 | China |
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|
| axillary drainage | Behavioral |
|
| reexamine | Other |
|
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003094 | Collagen |
| C569879 | streptococcal preparation 722 |
| ID | Term |
|---|---|
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D016326 | Extracellular Matrix Proteins |
| D012596 | Scleroproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
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