<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/NCT02235285</url>
  </required_header>
  <id_info>
    <org_study_id>Breast Augmentarion</org_study_id>
    <nct_id>NCT02235285</nct_id>
  </id_info>
  <brief_title>Asian Outcomes of Primary Breast Augmentation</brief_title>
  <acronym>BA</acronym>
  <official_title>Asian Outcomes of Primary Breast Augmentation in 162 Consecutive Cases Using Single Antibiotic Breast Irrigation by A Single Surgeon Under Sedative Anesthesia (Propofol Infusion)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Winners Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Winners Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In 162 Asian patients, primary breast augmentations were performed by a single surgeon during&#xD;
      5 years. The purpose of this study evaluates Asian outcomes in primary breast augmentation&#xD;
      using single antibiotic breast irrigation by a single surgeon's practice and examines the&#xD;
      comparison of Asian and Western outcomes in primary breast augmentation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A retrospective chart review was performed to examine a total of 162 patients received the&#xD;
      same brand of implants for primary breast augmentation under sedative anesthesia (propofol&#xD;
      infusion) in a single surgeon's practice. Asian patients' demographics, preoperative and&#xD;
      postoperative measurements, surgical technique (single antibiotic breast irrigation), implant&#xD;
      type, size, texture, soft tissue coverage, implant placement, incision approach,&#xD;
      complications, and incidence of reoperation were documented.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">April 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Post Surgical Complications and Reoperation Rate During Breast Augmentation</measure>
    <time_frame>5 years</time_frame>
    <description>The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Breast Augmentation</condition>
  <arm_group>
    <arm_group_label>breast augmentation,reoperation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A retrospective chart review was performed to examine a total of 162 patients received the same brand of implants for primary breast augmentation under sedative anesthesia (propofol infusion) in a single surgeon's practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>primary breast augmentation</intervention_name>
    <description>With the patient under sedative anesthesia, wide preparation and draping by using povidone-iodine are performed with using talc-free gloves and povidone-iodine gauze nipple shields. Tumescent solution is infiltrated in the precise plane. Pockets are developed precisely with blunt dissection with fingers and instruments under both direct and indirect visions simultaneously, if needed, with using endoscopy, while careful hemostasis done. After dissection, two pockets are irrigated with 300ml of single antibiotic solution without active evacuation of the irrigation. When re-draping and re-preparation by using povidone-iodine are performed before implant insertion, a new pair of talc-free gloves is used and cleansed with the single antibiotic solution.</description>
    <arm_group_label>breast augmentation,reoperation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary case&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  secondary case&#xD;
&#xD;
          -  breast reduction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>57 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CHEOLHWAN KIM, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Winners Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Department of Plastic Surgery, Winners Clinic</name>
      <address>
        <city>Seoul</city>
        <zip>135-893</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>Spear SL, Murphy DK, Slicton A, Walker PS; Inamed Silicone Breast Implant U.S. Study Group. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):8S-16S. doi: 10.1097/01.prs.0000286580.93214.df.</citation>
    <PMID>18090808</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</study_first_posted>
  <results_first_submitted>June 19, 2015</results_first_submitted>
  <results_first_submitted_qc>August 18, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">September 21, 2015</results_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>capsular contracture</keyword>
  <keyword>reoperation</keyword>
  <keyword>breast augmentation</keyword>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Retrospective analysis was performed on 162 patients undergoing primary breast augmentation by a single surgeon during a 5-year period from 2010 to 2015.</recruitment_details>
      <pre_assignment_details>This study presents data for 162 primary breast augmentation in either alone (n=152; 93.82 percent) or in conjunction with mastopexy (n=9; 5.56 percent) and inverted nipple correction (n=1; 0.62 percent) .</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Breast Augmentation,Reoperation</title>
          <description>The most common cause of reoperation in breast augmentation is a capsular contracture. So the prevention of capsular contracture is very important in breast augmentation. The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon. The rate of follow-up at 5 years for all patients was 92 percent.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="149"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="13"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>All Study Participants</title>
          <description>Participants were 162-consecutive patients underwent primary breast augmentation by one surgeon.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="162"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.98" spread="8.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="162"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Korea, Republic of</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="162"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Post Surgical Complications and Reoperation Rate During Breast Augmentation</title>
        <description>The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.</description>
        <time_frame>5 years</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Breast Augmentation, Reoperation</title>
            <description>The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.</description>
          </group>
        </group_list>
        <measure>
          <title>Post Surgical Complications and Reoperation Rate During Breast Augmentation</title>
          <description>The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.</description>
          <units>percentage of participants</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>reoperation rate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.85" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>complications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.85" spread="0.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>5 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Breast Augmentation, Reoperation</title>
          <description>The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 10.0</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Capsular contracture</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Rippling</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Cheol Hwan Kim</name_or_title>
      <organization>The Department of Plastic Surgery, Winners Clinic</organization>
      <phone>.+82.2.511.9446</phone>
      <email>winners511@naver.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02235285
org study id: Breast Augmentarion
nct id: NCT02235285
lead sponsor: 
has dmc: No
In 162 Asian patients, primary breast augmentations were performed by a single surgeon during
      5 years. The purpose of this study evaluates Asian outcomes in primary breast augmentation
      using single antibiotic breast irrigation by a single surgeon's practice and examines the
      comparison of Asian and Western outcomes in primary breast augmentation.
A retrospective chart review was performed to examine a total of 162 patients received the
      same brand of implants for primary breast augmentation under sedative anesthesia (propofol
      infusion) in a single surgeon's practice. Asian patients' demographics, preoperative and
      postoperative measurements, surgical technique (single antibiotic breast irrigation), implant
      type, size, texture, soft tissue coverage, implant placement, incision approach,
      complications, and incidence of reoperation were documented.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Post Surgical Complications and Reoperation Rate During Breast Augmentation
time frame: 5 years
description: The investigators reviewed 162-consecutive patients underwent breast augmentation by one surgeon for reoperation rate.
arm group label: breast augmentation,reoperation
arm group type: Experimental
description: A retrospective chart review was performed to examine a total of 162 patients received the same brand of implants for primary breast augmentation under sedative anesthesia (propofol infusion) in a single surgeon's practice.
intervention type: Procedure
intervention name: primary breast augmentation
description: With the patient under sedative anesthesia, wide preparation and draping by using povidone-iodine are performed with using talc-free gloves and povidone-iodine gauze nipple shields. Tumescent solution is infiltrated in the precise plane. Pockets are developed precisely with blunt dissection with fingers and instruments under both direct and indirect visions simultaneously, if needed, with using endoscopy, while careful hemostasis done. After dissection, two pockets are irrigated with 300ml of single antibiotic solution without active evacuation of the irrigation. When re-draping and re-preparation by using povidone-iodine are performed before implant insertion, a new pair of talc-free gloves is used and cleansed with the single antibiotic solution.
arm group label: breast augmentation,reoperation
criteria: 
gender: All
minimum age: 22 Years
maximum age: 57 Years
healthy volunteers: Accepts Healthy Volunteers
last name: CHEOLHWAN KIM, M.D.
role: Principal Investigator
affiliation: Winners Clinic
facility: 
country: Korea, Republic of
citation: Spear SL, Murphy DK, Slicton A, Walker PS; Inamed Silicone Breast Implant U.S. Study Group. Inamed silicone breast implant core study results at 6 years. Plast Reconstr Surg. 2007 Dec;120(7 Suppl 1):8S-16S. doi: 10.1097/01.prs.0000286580.93214.df.
PMID: 18090808
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 