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

Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure--- a Randomized Control Clinical Trial

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01731769

Enrollment

Registered

2012-11-22

Start date

2013-01-31

Completion date

2013-03-31

Last updated

2012-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Keywords

Seroma Formation, Axillary Lymph Node Dissection, Breast cancer, Early Vacuum Assisted Closure

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.

Interventions

PROCEDUREvacuum assisted closure in experimental arm

PROCEDUREAxillary dissection

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Countries

China

Contacts

Primary ContactHongda Bi, Ph.D

bihongda0411@yahoo.com.cn

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026