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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

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