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Trial Title:
Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure
NCT ID:
NCT01731769
Condition:
Breast Neoplasms
Conditions: Official terms:
Breast Neoplasms
Seroma
Conditions: Keywords:
Seroma Formation
Axillary Lymph Node Dissection
Breast cancer
Early Vacuum Assisted Closure
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
vacuum assisted closure in experimental arm
Arm group label:
vacuum assisted closure
Intervention type:
Procedure
Intervention name:
Axillary dissection
Arm group label:
Axillary dissection
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:
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
Gender:
Female
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Changhai Hospital
Address:
City:
Shanghai
Zip:
200433
Country:
China
Contact:
Last name:
Hongda Bi, Ph.D
Email:
bihongda0411@yahoo.com.cn
Start date:
January 2013
Completion date:
March 2013
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01731769
