<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01731769</url>
  </required_header>
  <id_info>
    <org_study_id>PSF-2012</org_study_id>
    <nct_id>NCT01731769</nct_id>
  </id_info>
  <brief_title>Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure</brief_title>
  <official_title>Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure--- a Randomized Control Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Changhai Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhai Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Axillary dissection is the standard treatment for breast cancer patients with positive nodes.&#xD;
      However, seroma formation after axillary dissection remains the most common early&#xD;
      complication to breast cancer surgery. It can delay the initiation of adjuvant therapy,&#xD;
      predispose to wound infection, delay wound healing and has also been linked to arm&#xD;
      lymphoedema. Based on some studies and our experience that vacuum assisted closure （VAC）is&#xD;
      effective in complex wound failures following axillary dissection and groin dissection, we&#xD;
      use VAC to prevent seroma formation after extensive axillary dissection. This study is aimed&#xD;
      to evaluate the efficacy, safety and economics benefits of early VAC application on&#xD;
      postoperative complications and wound healing after extensive axillary dissection in&#xD;
      comparison to conventional suction drain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>seroma formation complication incidence</measure>
    <time_frame>within the first 30 days (plus or minus 3 days) after surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>Axillary dissection</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>vacuum assisted closure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>vacuum assisted closure in experimental arm</intervention_name>
    <arm_group_label>vacuum assisted closure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Axillary dissection</intervention_name>
    <arm_group_label>Axillary dissection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
          -  patients diagnosed with breast cancer, receiving modified radical mastectomy and&#xD;
             axillary dissection；&#xD;
&#xD;
          -  Body Mass Index ≥28；&#xD;
&#xD;
          -  drainage volume within the first 48 hours is more than 200 mL.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with coagulation disorders shown by exceeding the normal range of any of&#xD;
             following: prothrombin time (PT), Quick, activated partial thromboplastin time (aPTT),&#xD;
             fibrinogen level, or thrombocytes.&#xD;
&#xD;
          -  Subjects having previously had axillary surgery,&#xD;
&#xD;
          -  Subjects having undergone irradiation therapy to the axillary tissue&#xD;
&#xD;
          -  Subjects having ever received chemotherapy before the surgery,&#xD;
&#xD;
          -  Subjects with known hypersensitivity to components of the surgical sticky membrane&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hongda Bi, Ph.D</last_name>
    <email>bihongda0411@yahoo.com.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Changhai Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Hongda Bi, Ph.D</last_name>
      <email>bihongda0411@yahoo.com.cn</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>November 19, 2012</last_update_submitted>
  <last_update_submitted_qc>November 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 22, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Bi-Hongda</investigator_full_name>
    <investigator_title>attending physician,department of plastic surgery</investigator_title>
  </responsible_party>
  <keyword>Seroma Formation</keyword>
  <keyword>Axillary Lymph Node Dissection</keyword>
  <keyword>Breast cancer</keyword>
  <keyword>Early Vacuum Assisted Closure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Seroma</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01731769
org study id: PSF-2012
nct id: NCT01731769
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: seroma formation complication incidence
time frame: within the first 30 days (plus or minus 3 days) after surgery
arm group label: Axillary dissection
arm group type: Active Comparator
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 group label: vacuum assisted closure
arm group type: Experimental
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: vacuum assisted closure in experimental arm
arm group label: vacuum assisted closure
intervention type: Procedure
intervention name: Axillary dissection
arm group label: Axillary dissection
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hongda Bi, Ph.D
email: bihongda0411@yahoo.com.cn
facility: 
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Changhai Hospital
investigator full name: Bi-Hongda
investigator title: attending physician,department of plastic surgery
mesh term: Breast Neoplasms
mesh term: Seroma