Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure--- a Randomized Control Clinical Trial
N/A
18 Years
80 Years
18 Years
80 Years
Not Enrolling
Female
Breast Neoplasms
Female
Breast Neoplasms
Trial Information
Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure--- a Randomized Control Clinical Trial
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
seroma formation complication incidence
Outcome Time Frame:
within the first 30 days (plus or minus 3 days) after surgery
Safety Issue:
Yes
Authority:
China: Ethics Committee
Study ID:
PSF-2012
NCT ID:
NCT01731769
Start Date:
January 2013
Completion Date:
March 2013
Related Keywords:
- Breast Neoplasms
- Seroma Formation
- Axillary Lymph Node Dissection
- Breast cancer
- Early Vacuum Assisted Closure
- Breast Neoplasms
- Neoplasms
- Seroma
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