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

Postoperative Complications Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02158299
• Other study ID #: Clinical trail003
• 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. 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

• Drainage
• Postoperative Complications

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