<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/NCT02263651</url>
  </required_header>
  <id_info>
    <org_study_id>PHRCK13 - LO / QUISERMAS</org_study_id>
    <secondary_id>2014-A00901-46</secondary_id>
    <secondary_id>140730B-12</secondary_id>
    <nct_id>NCT02263651</nct_id>
  </id_info>
  <brief_title>Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage</brief_title>
  <acronym>QUISERMAS</acronym>
  <official_title>Dead Space Closure With Quilting Suture Versus Conventional Closure With Drainage in Prevention of Seroma Formation After Mastectomy for Breast Cancer : a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Tours</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Tours</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to compare quilting suture of the &quot;dead space&quot; without&#xD;
      drainage of the pectoral area to conventional closure with drainage to prevent post-operative&#xD;
      seroma requiring intervention (aspiration or surgical intervention) within 21 days after&#xD;
      mastectomy for breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients are patients with operable breast cancer (invasive carcinoma and/or&#xD;
      carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either&#xD;
      alone or in association with sentinel lymph node biopsy or standard level I/II axillary node&#xD;
      dissection&#xD;
&#xD;
      Randomization will be stratified by center and by type of surgery (mastectomy alone/&#xD;
      mastectomy with sentinel node biopsy / mastectomy with axillary lymph node dissection).&#xD;
&#xD;
      Two follow-up visits will be performed: at 21 days and 9 months after surgery, these&#xD;
      appointments are conventional, thus our trial will not modify usual follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">October 2018</completion_date>
  <primary_completion_date type="Actual">October 2018</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound seroma requiring aspiration or surgical intervention</measure>
    <time_frame>Within 21 days following mastectomy</time_frame>
    <description>A seroma is defined as a postoperative fluid collection via palpation on clinical examination. The Common Terminology Criteria for Adverse Events (CTCAE) which is a descriptive terminology that can be used for adverse event reporting provide a grading scale for seromas (lymphoceles).&#xD;
Only grade 2 and 3 seromas i.e. seromas requiring one or more aspirations or a surgical intervention will be considered as primary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wound seroma requiring aspiration or surgical intervention</measure>
    <time_frame>Within 9 months following mastectomy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound seroma whatever their type (requiring or not intervention)</measure>
    <time_frame>Within 21 days following mastectomy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wound seroma whatever their type (requiring or not intervention)</measure>
    <time_frame>Within 9 months following mastectomy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other wound complications</measure>
    <time_frame>Within 21 days following mastectomy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other wound complications</measure>
    <time_frame>Within 9 months following mastectomy</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgical morbidity</measure>
    <time_frame>During surgical intervention</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>Before surgery, day 1, 21 days and 9 months following mastectomy</time_frame>
    <description>Visual Analogue Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Homolateral shoulder movement</measure>
    <time_frame>Before surgery, 21 days and 9 months following mastectomy</time_frame>
    <description>The range of arm movement scored from 1 to 4 according to estimated angles of arm abduction as 1 (less than 90°), 2 (90-134°), 3 (135-179°) and 4 (180°)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cosmesis results</measure>
    <time_frame>21 days, 9 months following mastectomy</time_frame>
    <description>Cosmetic results will be documented by patient,surgeon and by an blinded adjudication committee with possible response = poor, acceptable, good and excellent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health related quality of life : EQ-5D-5L</measure>
    <time_frame>Before surgery, day 1, 21 days and 9 months following mastectomy</time_frame>
    <description>The descriptive system comprises 5 dimensions : mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness assessment</measure>
    <time_frame>During the whole follow-up period i.e. 9 months following mastectomy</time_frame>
    <description>Incremental net monetary benefice</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">320</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Closure with conventional technique with drainage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Quilting suture without drainage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (&lt;2cm) are placed from the skin flaps to the underlying muscle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quilting suture without drainage</intervention_name>
    <description>In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (&lt;2cm) are placed from the skin flaps to the underlying muscle. Minor dimpling is considered acceptable and is expected to resolve. If severe dimpling is observed, stitches are removed and replaced.&#xD;
Efficiency of quilting suture relies on a rigorous repartition of the sutures with a special attention taken to the obliteration of the largest potential dead spaces and the empty axillary apex.&#xD;
The skin edges are sutured as stated before for the control group. Closed suction will not be used for draining the pectoral area.</description>
    <arm_group_label>Quilting suture without drainage</arm_group_label>
    <other_name>Quilting suture</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional closure with drainage</intervention_name>
    <description>The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.&#xD;
The skin is closed in two layers with absorbable sutures, a deep layer of 2.0 or 3.0 vicryl sutures or equivalent, and a subcuticular closure with absorbable 3.0 or 4.0 Monocryl sutures or equivalent.</description>
    <arm_group_label>Closure with conventional technique with drainage</arm_group_label>
    <other_name>Conventional closure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women ≥ 18 years and ≤ 85 years&#xD;
&#xD;
          -  Women with operable breast cancer (invasive carcinoma and/or carcinoma in situ) for&#xD;
             whom mastectomy is recommended or preferred by the patient either alone or in&#xD;
             association with sentinel lymph node biopsy or standard level I/II axillary node&#xD;
             dissection&#xD;
&#xD;
          -  Women that give her informed written consent&#xD;
&#xD;
          -  French social security affiliation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any physical or psychiatric condition that could impair with patient's ability to&#xD;
             cooperate with postoperative data collection.&#xD;
&#xD;
          -  Women with indication of bilateral mastectomy or immediate reconstruction.&#xD;
&#xD;
          -  Degenerative neuromuscular disease with thoracic muscular damage&#xD;
&#xD;
          -  Planned ambulatory surgery&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lobna OULDAMER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Tours</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Conception Hospital</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut POALI-CALMETTES</name>
      <address>
        <city>Marseille</city>
        <zip>13009</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de l'Ouest</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance Clinic</name>
      <address>
        <city>St Cyr sur Loire</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 29, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 19, 2018</last_update_submitted>
  <last_update_submitted_qc>October 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast cancer</keyword>
  <keyword>Mastectomy</keyword>
  <keyword>Seroma</keyword>
  <keyword>Quilting suture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02263651
org study id: PHRCK13 - LO / QUISERMAS
secondary id: 2014-A00901-46
secondary id: 140730B-12
nct id: NCT02263651
lead sponsor: 
has dmc: No
The objective of this study is to compare quilting suture of the "dead space" without
      drainage of the pectoral area to conventional closure with drainage to prevent post-operative
      seroma requiring intervention (aspiration or surgical intervention) within 21 days after
      mastectomy for breast cancer.
Eligible patients are patients with operable breast cancer (invasive carcinoma and/or
      carcinoma in situ) for whom mastectomy is recommended or preferred by the patient either
      alone or in association with sentinel lymph node biopsy or standard level I/II axillary node
      dissection

      Randomization will be stratified by center and by type of surgery (mastectomy alone/
      mastectomy with sentinel node biopsy / mastectomy with axillary lymph node dissection).

      Two follow-up visits will be performed: at 21 days and 9 months after surgery, these
      appointments are conventional, thus our trial will not modify usual follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: Wound seroma requiring aspiration or surgical intervention
time frame: Within 21 days following mastectomy
description: A seroma is defined as a postoperative fluid collection via palpation on clinical examination. The Common Terminology Criteria for Adverse Events (CTCAE) which is a descriptive terminology that can be used for adverse event reporting provide a grading scale for seromas (lymphoceles).
Only grade 2 and 3 seromas i.e. seromas requiring one or more aspirations or a surgical intervention will be considered as primary outcome.
measure: Wound seroma requiring aspiration or surgical intervention
time frame: Within 9 months following mastectomy
measure: Wound seroma whatever their type (requiring or not intervention)
time frame: Within 21 days following mastectomy
measure: Wound seroma whatever their type (requiring or not intervention)
time frame: Within 9 months following mastectomy
measure: Other wound complications
time frame: Within 21 days following mastectomy
measure: Other wound complications
time frame: Within 9 months following mastectomy
measure: Surgical morbidity
time frame: During surgical intervention
measure: Pain
time frame: Before surgery, day 1, 21 days and 9 months following mastectomy
description: Visual Analogue Scale
measure: Homolateral shoulder movement
time frame: Before surgery, 21 days and 9 months following mastectomy
description: The range of arm movement scored from 1 to 4 according to estimated angles of arm abduction as 1 (less than 90°), 2 (90-134°), 3 (135-179°) and 4 (180°)
measure: Cosmesis results
time frame: 21 days, 9 months following mastectomy
description: Cosmetic results will be documented by patient,surgeon and by an blinded adjudication committee with possible response = poor, acceptable, good and excellent
measure: Health related quality of life : EQ-5D-5L
time frame: Before surgery, day 1, 21 days and 9 months following mastectomy
description: The descriptive system comprises 5 dimensions : mobility, self care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems
measure: Cost-effectiveness assessment
time frame: During the whole follow-up period i.e. 9 months following mastectomy
description: Incremental net monetary benefice
arm group label: Closure with conventional technique with drainage
arm group type: Active Comparator
description: The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.
arm group label: Quilting suture without drainage
arm group type: Experimental
description: In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (<2cm) are placed from the skin flaps to the underlying muscle.
intervention type: Procedure
intervention name: Quilting suture without drainage
description: In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (<2cm) are placed from the skin flaps to the underlying muscle. Minor dimpling is considered acceptable and is expected to resolve. If severe dimpling is observed, stitches are removed and replaced.
Efficiency of quilting suture relies on a rigorous repartition of the sutures with a special attention taken to the obliteration of the largest potential dead spaces and the empty axillary apex.
The skin edges are sutured as stated before for the control group. Closed suction will not be used for draining the pectoral area.
arm group label: Quilting suture without drainage
other name: Quilting suture
intervention type: Procedure
intervention name: Conventional closure with drainage
description: The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.
The skin is closed in two layers with absorbable sutures, a deep layer of 2.0 or 3.0 vicryl sutures or equivalent, and a subcuticular closure with absorbable 3.0 or 4.0 Monocryl sutures or equivalent.
arm group label: Closure with conventional technique with drainage
other name: Conventional closure
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Lobna OULDAMER, MD
role: Principal Investigator
affiliation: University Hospital, Tours
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided