Back to resultsPreventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure
Primary Purpose
Breast Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
vacuum assisted closure in experimental arm
Axillary dissection
Sponsored by
About this trial
This is an interventional prevention trial for Breast Neoplasms focused on measuring Seroma Formation, Axillary Lymph Node Dissection, Breast cancer, Early Vacuum Assisted Closure
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
Sites / Locations
- Changhai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Axillary dissection
vacuum assisted closure
Arm Description
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 (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.
Outcomes
Primary Outcome Measures
seroma formation complication incidence
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01731769
Brief Title
Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure
Official Title
Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure--- a Randomized Control Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
March 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
Seroma Formation, Axillary Lymph Node Dissection, Breast cancer, Early Vacuum Assisted Closure
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Axillary dissection
Arm Type
Active Comparator
Arm Description
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).
Arm Title
vacuum assisted closure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
vacuum assisted closure in experimental arm
Intervention Type
Procedure
Intervention Name(s)
Axillary dissection
Primary Outcome Measure Information:
Title
seroma formation complication incidence
Time Frame
within the first 30 days (plus or minus 3 days) after surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongda Bi, Ph.D
Email
bihongda0411@yahoo.com.cn
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongda Bi, Ph.D
Email
bihongda0411@yahoo.com.cn
12. IPD Sharing Statement
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Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure
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