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Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
Seroma Formation, Axillary Lymph Node Dissection, Breast cancer, Early Vacuum Assisted Closure
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Intervention
Name: vacuum assisted closure in experimental arm
Type: Procedure
Name: Axillary dissection
Type: Procedure
Overall Status
Not yet recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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
- 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
Location
Changhai Hospital
Shanghai, Shanghai, China
Status: Not yet recruiting
Contact: Hongda Bi, Ph.D - bihongda0411@yahoo.com.cn
Start Date
January 2013
Completion Date
March 2013
Sponsors
Changhai Hospital
Source
Changhai Hospital
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page