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

Sun Yat-sen University

Status and phase: Unknown; Phase 4

Conditions: Postoperative Complications; Drainage

Treatments: Drug: Sapylin; Drug: Avitene; Other: reexamine; Behavioral: axillary drainage

Study type: Interventional

Funder types: Other

Identifiers

NCT02158299

Clinical trail003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

3 participants in 3 patient groups

Avitene,Drainaging,reexamine

Experimental group

Treatment:

Other: reexamine

Behavioral: axillary drainage

Drug: Avitene

Sapylin,Drainaging,reexamine

Experimental group

Treatment:

Other: reexamine

Behavioral: axillary drainage

Drug: Sapylin

Drainaging,reexamine

Active Comparator group

Treatment:

Other: reexamine

Behavioral: axillary drainage