Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure

Naval Military Medical University

Status: Unknown

Conditions: Breast Neoplasms

Treatments: Procedure: Axillary dissection; Procedure: vacuum assisted closure in experimental arm

Study type: Interventional

Funder types: Other

Identifiers

NCT01731769

PSF-2012

Details and patient eligibility

About

Axillary dissection is the standard treatment for breast cancer patients with positive nodes. However, seroma formation after axillary dissection remains the most common early complication to breast cancer surgery. It can delay the initiation of adjuvant therapy, predispose to wound infection, delay wound healing and has also been linked to arm lymphoedema. Based on some studies and our experience that vacuum assisted closure （VAC）is effective in complex wound failures following axillary dissection and groin dissection, we use VAC to prevent seroma formation after extensive axillary dissection. This study is aimed to evaluate the efficacy, safety and economics benefits of early VAC application on postoperative complications and wound healing after extensive axillary dissection in comparison to conventional suction drain.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• patients diagnosed with breast cancer, receiving modified radical mastectomy and axillary dissection；
• Body Mass Index ≥28；
• drainage volume within the first 48 hours is more than 200 mL.

Exclusion criteria

• Subjects with coagulation disorders shown by exceeding the normal range of any of following: prothrombin time (PT), Quick, activated partial thromboplastin time (aPTT), fibrinogen level, or thrombocytes.
• Subjects having previously had axillary surgery,
• Subjects having undergone irradiation therapy to the axillary tissue
• Subjects having ever received chemotherapy before the surgery,
• Subjects with known hypersensitivity to components of the surgical sticky membrane

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Axillary dissection

Active Comparator group

Description:

Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).

Treatment:

Procedure: Axillary dissection

vacuum assisted closure

Experimental group

Description:

Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.

Treatment:

Procedure: vacuum assisted closure in experimental arm