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

Not Applicable

• Conditions: Breast Neoplasms
• Interventions: Procedure: Axillary dissection; Procedure: vacuum assisted closure in experimental arm

• Registration Number: NCT01731769
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-11
• Study First Submitted: 2012-11-19
• Study First Submitted QC: 2012-11-19
• Last Update Submitted: 2012-11-19
• Study First Posted: 2012-11-22
• Last Update Posted: 2012-11-22
• Study Start: 2013-01
• Primary Completion: 2013-01
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Axillary dissection	Axillary dissection	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).
vacuum assisted closure	vacuum assisted closure in experimental arm	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.

Primary Outcome Measures

Name	Time	Method
seroma formation complication incidence	within the first 30 days (plus or minus 3 days) after surgery

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China