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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02158299
Other study ID # Clinical trail003
Secondary ID
Status Recruiting
Phase Phase 4
First received May 22, 2014
Last updated June 4, 2014
Start date October 2013

Study information

Verified date June 2014
Source Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Contact Jia Wei juan
Phone +86-20-34071157
Email 13560328074@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 3
Est. completion date
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Avitene

Sapylin

Behavioral:
axillary drainage

Other:
reexamine


Locations

Country Name City State
China Sun Yat-sen Memorial Hospital of Sun Yat-sen University Guangzhou Guangdong

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other The complications of seroma formation up to 1 year Yes
Primary postoperative drainage magnitude up to 1 year Yes
Secondary Duration of the drainage up to 1 year Yes
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