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Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure

This study is not yet open for participant recruitment.
Verified November 2012 by Changhai Hospital
Sponsor:
Information provided by (Responsible Party):
Bi-Hongda, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT01731769
First received: November 19, 2012
Last updated: NA
Last verified: November 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Breast Neoplasms
 Procedure: vacuum assisted closure in experimental arm
Procedure: Axillary dissection

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure--- a Randomized Control Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • seroma formation complication incidence [ Time Frame: within the first 30 days (plus or minus 3 days) after surgery ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: January 2013
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Axillary dissection
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).
 Procedure: Axillary dissection
Experimental: vacuum assisted closure
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.
 Procedure: vacuum assisted closure in experimental arm

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731769

Contacts
Contact: Hongda Bi, Ph.D bihongda0411@yahoo.com.cn

Locations
China, Shanghai
Changhai Hospital Not yet recruiting
Shanghai, Shanghai, China, 200433
Contact: Hongda Bi, Ph.D         bihongda0411@yahoo.com.cn    
Sponsors and Collaborators
Changhai Hospital
  More Information

No publications provided

Responsible Party: Bi-Hongda, attending physician,department of plastic surgery, Changhai Hospital
ClinicalTrials.gov Identifier: NCT01731769     History of Changes
Other Study ID Numbers: PSF-2012
Study First Received: November 19, 2012
Last Updated: November 19, 2012
Health Authority: China: Ethics Committee

Keywords provided by Changhai Hospital:
Seroma Formation
Axillary Lymph Node Dissection
Breast cancer
Early Vacuum Assisted Closure

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Seroma
Neoplasms by Site
 Breast Diseases
Skin Diseases
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 22, 2013