<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/NCT03792737</url>
  </required_header>
  <id_info>
    <org_study_id>ESC-201702</org_study_id>
    <nct_id>NCT03792737</nct_id>
  </id_info>
  <brief_title>A Study of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision</brief_title>
  <acronym>Nautilus</acronym>
  <official_title>A Prospective, Multi-center, Randomized Controlled Study Evaluating the Efficacy and Safety of Two Types of Absorbable Surgical Sutures in the Suturing of Thyroid Surgery Incision</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ethicon, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ethicon, Inc.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary objective of this study is to evaluate the efficacy and safety of two types of&#xD;
      absorbable surgical sutures -- STRATAFIX Spiral PDS Knotless Plus Tissue Control Device and&#xD;
      STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (hereinafter referred to as&#xD;
      Spiral PDS Plus and Spiral MONOCRYL Plus) used in thyroid surgery to suture surgical&#xD;
      incision.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study adopts a multicenter, prospective, randomized controlled design. The study&#xD;
      population are subjects who undergo thyroid surgery.&#xD;
&#xD;
      Before the surgery, subjects are randomized in 1:1:1 ratio to the investigational group 1&#xD;
      (using Spiral PDS Plus), investigational group 2 (using Spiral MONOCRYL Plus) and control&#xD;
      group. See the table below for the specific suture levels, materials and techniques of each&#xD;
      group.&#xD;
&#xD;
      A blinded central imaging evaluation will be performed on the healing condition of surgical&#xD;
      incision on Day 5-7 post-surgery. The subjects will be blinded to the type of suture used for&#xD;
      wound closure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">January 6, 2020</completion_date>
  <primary_completion_date type="Actual">December 12, 2019</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>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Wound Healing Grade</measure>
    <time_frame>5-7days</time_frame>
    <description>Percentage of Participants with Grade A Healing of Surgical Incision</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incision Closure Time</measure>
    <time_frame>during surgery, an average of around 12 Mins</time_frame>
    <description>the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative Incisional Pain Score (Visual Analogue Scale, VAS)</measure>
    <time_frame>5-7 Days after Surgery and 28-35 Days after Surgery</time_frame>
    <description>For the postoperative incisional pain score, a score of 0 means no pain, and a score of 10 means unbearable: severely affects sleep with other symptoms, or passive position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Hollander Wound Evaluation Scale - FAS</measure>
    <time_frame>28-35 days</time_frame>
    <description>Total cosmetic score. Assessed by Central Imaging evaluators using incision pictures to evaluate healing status. range is from 0 to 5, 0 is best and 5 is worst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life Scale (EQ-5D-5L)</measure>
    <time_frame>5-7 days after surgery</time_frame>
    <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1, 0 is better and 1 is worse</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Related Quality of Life Scale (EQ-5D-5L)</measure>
    <time_frame>28-35 days after surgery</time_frame>
    <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1. 0 is better and 1 is worse.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of EQ-5D VAS Score</measure>
    <time_frame>5-7 Days after surgery</time_frame>
    <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100. 100 is best and 0 is worst.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of EQ-5D VAS Score</measure>
    <time_frame>28-35 Days after surgery</time_frame>
    <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">501</enrollment>
  <condition>Sutures</condition>
  <arm_group>
    <arm_group_label>Investigational group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Investigational group 1: Use the study device Spiral PDS Plus for continuous suture of the ribbon muscles, VICRYL Plus for interrupted suture of the platysma, and MONOCRYL Plus for continuous subcuticular suture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Investigational group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Investigational group 2: Use PDS Plus for continuous suture of the ribbon muscles, VICRYL Plus for interrupted suture of the platysma, and the study device Spiral MONOCRYL Plus for continuous subcuticular suture.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group: Use the control device PDS Plus for continuous suture of the ribbon muscles, VICRYL Plus for interrupted suture of the platysma, and the control device MONOCRYL Plus continuous subcuticular suture.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spiral PDS Plus</intervention_name>
    <description>The Spiral PDS Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral PDS Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.</description>
    <arm_group_label>Investigational group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Spiral MONOCRYL Plus</intervention_name>
    <description>The Spiral MONOCRYL Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral MONOCRYL Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.</description>
    <arm_group_label>Investigational group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PDS Plus</intervention_name>
    <description>PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Investigational group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MONOCRYL Plus</intervention_name>
    <description>MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Investigational group 1</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VICRYL Plus</intervention_name>
    <description>VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Investigational group 1</arm_group_label>
    <arm_group_label>Investigational group 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The subject is ≥18, and &lt;70 years old&#xD;
&#xD;
          2. Planned open thyroid surgery, adopting an anterior cervical curved incision (Kocher's&#xD;
             incision);&#xD;
&#xD;
          3. Subject who volunteers to participate in this study, follows the study requirements&#xD;
             and follow-up visit and signs the written Informed Consent Form voluntarily;&#xD;
&#xD;
          4. Subject who agrees to not schedule any elective surgical operation except the study&#xD;
             surgery before the study is completed;&#xD;
&#xD;
          5. The investigator considers the subject's expected postoperative survival time is not&#xD;
             less than 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female subjects who are pregnant or lactation at screening;&#xD;
&#xD;
          2. Preoperative clinical staging shows stage IV thyroid cancer, or cervical lymph nodes&#xD;
             dissection is planned;&#xD;
&#xD;
          3. Suspected or confirmed anaplastic thyroid cancer;&#xD;
&#xD;
          4. Peripheral vascular disease affecting blood supply of the neck;&#xD;
&#xD;
          5. Active infectious collagenosis (e.g. scleroderma), or any other disease that would&#xD;
             interfere with wound healing;&#xD;
&#xD;
          6. Fasting plasma glucose ≥7.7 mmol/L;&#xD;
&#xD;
          7. History of coagulation diseases;&#xD;
&#xD;
          8. Current oral or intravenous antibiotic therapy for existing disease or infection;&#xD;
&#xD;
          9. History of immunosuppressant use (e.g. steroids) within the last 6 months;&#xD;
&#xD;
         10. Chemotherapy or radiotherapy within the last 6 months, or planned chemotherapy or&#xD;
             radiotherapy during the study;&#xD;
&#xD;
         11. Personal or family history of keloid formation or hyperplasia;&#xD;
&#xD;
         12. Current participation in any other drug (within 30 days or within 5 half-lives of the&#xD;
             investigational drug) or device clinical study;&#xD;
&#xD;
         13. History of any thyroid surgery, except thyroid fine-needle aspiration biopsy;&#xD;
&#xD;
         14. Planned use of skin adhesive at the incision site;&#xD;
&#xD;
         15. The subject is not suitable for participating in this study for any other reasons, as&#xD;
             judged by the investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>69 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hao Zhang</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Hospital of China Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fujian Medical University Union Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Peking University Shenzhen Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <zip>518035</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Union Hospital Tongji Medical college Huazhong University of science and technologyUnion Hospital Tongji Medical college Huazhong University of science and technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu Province Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of China Medical University</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <zip>110001</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'An Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sicuan Province</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital, Zhejiang University</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Friendship Hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>November 29, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <results_first_submitted>December 11, 2020</results_first_submitted>
  <results_first_submitted_qc>January 26, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">January 29, 2021</results_first_posted>
  <last_update_submitted>February 1, 2022</last_update_submitted>
  <last_update_submitted_qc>February 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 5, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 30, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03792737/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT03792737/SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so in protocol enrollment plan is 501 subjects, but actually received screen and randomization is 500 patients.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Investigational Group 1</title>
          <description>Spiral PDS Plus</description>
        </group>
        <group group_id="P2">
          <title>Investigational Group 2</title>
          <description>Spiral MONOCRYL Plus</description>
        </group>
        <group group_id="P3">
          <title>Control groupEdit</title>
          <description>PDS Plus or Monocryl Plus</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="166"/>
                <participants group_id="P2" count="167"/>
                <participants group_id="P3" count="167"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Safety Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
                <participants group_id="P2" count="161">one subject didn't participate screen visit or randomize, but receive IP treatment by mistake.</participants>
                <participants group_id="P3" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Full Analysis Set</title>
              <participants_list>
                <participants group_id="P1" count="162"/>
                <participants group_id="P2" count="160"/>
                <participants group_id="P3" count="162"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="160"/>
                <participants group_id="P2" count="159"/>
                <participants group_id="P3" count="158"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="8"/>
                <participants group_id="P3" count="9"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Full Analysis Population(FAS): FAS consists of all the enrolled subjects who were randomized and at least post-baseline effectiveness endpoint evaluation.</population>
      <group_list>
        <group group_id="B1">
          <title>Investigational Group 1</title>
          <description>Spiral PDS Plus</description>
        </group>
        <group group_id="B2">
          <title>Investigational Group 2</title>
          <description>Spiral MONOCRYL Plus</description>
        </group>
        <group group_id="B3">
          <title>Control groupEdit</title>
          <description>PDS Plus or Monocryl Plus</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="162"/>
            <count group_id="B2" value="160"/>
            <count group_id="B3" value="162"/>
            <count group_id="B4" value="484"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <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="40.1" spread="10.66"/>
                    <measurement group_id="B2" value="41.2" spread="10.84"/>
                    <measurement group_id="B3" value="40.3" spread="11.32"/>
                    <measurement group_id="B4" value="40.5" spread="10.93"/>
                  </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="107"/>
                    <measurement group_id="B2" value="118"/>
                    <measurement group_id="B3" value="111"/>
                    <measurement group_id="B4" value="336"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="55"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="148"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Han</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="158"/>
                    <measurement group_id="B2" value="157"/>
                    <measurement group_id="B3" value="155"/>
                    <measurement group_id="B4" value="470"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                    <measurement group_id="B4" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Wound Healing Grade</title>
        <description>Percentage of Participants with Grade A Healing of Surgical Incision</description>
        <time_frame>5-7days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Investigational group1</title>
            <description>Spiral PDS Plus</description>
          </group>
          <group group_id="O2">
            <title>Investigational group2</title>
            <description>Spiral MONOCRYL Plus</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>PDS Plus or Monocryl Plus</description>
          </group>
        </group_list>
        <measure>
          <title>Wound Healing Grade</title>
          <description>Percentage of Participants with Grade A Healing of Surgical Incision</description>
          <units>percentage</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="154"/>
                <count group_id="O2" value="157"/>
                <count group_id="O3" value="156"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.35" lower_limit="96.44" upper_limit="99.98"/>
                    <measurement group_id="O2" value="98.73" lower_limit="95.47" upper_limit="99.85"/>
                    <measurement group_id="O3" value="99.36" lower_limit="96.48" upper_limit="99.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incision Closure Time</title>
        <description>the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes)</description>
        <time_frame>during surgery, an average of around 12 Mins</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Investigational group1</title>
            <description>Spiral PDS Plus</description>
          </group>
          <group group_id="O2">
            <title>Investigational group2</title>
            <description>Spiral MONOCRYL Plus</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>PDS Plus or Monocryl Plus</description>
          </group>
        </group_list>
        <measure>
          <title>Incision Closure Time</title>
          <description>the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes)</description>
          <units>minutes</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 group_id="O2" value="160"/>
                <count group_id="O3" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.285" spread="3.2635"/>
                    <measurement group_id="O2" value="11.198" spread="3.1298"/>
                    <measurement group_id="O3" value="11.634" spread="3.4327"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Postoperative Incisional Pain Score (Visual Analogue Scale, VAS)</title>
        <description>For the postoperative incisional pain score, a score of 0 means no pain, and a score of 10 means unbearable: severely affects sleep with other symptoms, or passive position.</description>
        <time_frame>5-7 Days after Surgery and 28-35 Days after Surgery</time_frame>
        <population>Full Analysis Set</population>
        <group_list>
          <group group_id="O1">
            <title>Investigational group1</title>
            <description>Spiral PDS Plus</description>
          </group>
          <group group_id="O2">
            <title>Investigational group2</title>
            <description>Spiral MONOCRYL Plus</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>PDS Plus or Monocryl Plus</description>
          </group>
        </group_list>
        <measure>
          <title>Postoperative Incisional Pain Score (Visual Analogue Scale, VAS)</title>
          <description>For the postoperative incisional pain score, a score of 0 means no pain, and a score of 10 means unbearable: severely affects sleep with other symptoms, or passive position.</description>
          <population>Full Analysis Set</population>
          <units>Units</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 group_id="O2" value="160"/>
                <count group_id="O3" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>VAS Scale-Visit 4 (5-7 Days after Surgery)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="1.49"/>
                    <measurement group_id="O2" value="1.5" spread="1.61"/>
                    <measurement group_id="O3" value="1.4" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>VAS Scale-Visit 5 (28-35 Days after Surgery)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.45" spread="0.775"/>
                    <measurement group_id="O2" value="0.63" spread="0.991"/>
                    <measurement group_id="O3" value="0.66" spread="1.319"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Modified Hollander Wound Evaluation Scale - FAS</title>
        <description>Total cosmetic score. Assessed by Central Imaging evaluators using incision pictures to evaluate healing status. range is from 0 to 5, 0 is best and 5 is worst</description>
        <time_frame>28-35 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Investigational group1</title>
            <description>Spiral PDS Plus</description>
          </group>
          <group group_id="O2">
            <title>Investigational group2</title>
            <description>Spiral MONOCRYL Plus</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>PDS Plus or Monocryl Plus</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Hollander Wound Evaluation Scale - FAS</title>
          <description>Total cosmetic score. Assessed by Central Imaging evaluators using incision pictures to evaluate healing status. range is from 0 to 5, 0 is best and 5 is worst</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="162"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2" spread="0.53"/>
                    <measurement group_id="O2" value="0.1" spread="0.38"/>
                    <measurement group_id="O3" value="0.1" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Related Quality of Life Scale (EQ-5D-5L)</title>
        <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1, 0 is better and 1 is worse</description>
        <time_frame>5-7 days after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Investigational group1</title>
            <description>Spiral PDS Plus</description>
          </group>
          <group group_id="O2">
            <title>Investigational group2</title>
            <description>Spiral MONOCRYL Plus</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>PDS Plus or Monocryl Plus</description>
          </group>
        </group_list>
        <measure>
          <title>Health Related Quality of Life Scale (EQ-5D-5L)</title>
          <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1, 0 is better and 1 is worse</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="160"/>
                <count group_id="O3" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.8627" spread="0.11007"/>
                    <measurement group_id="O2" value="0.8537" spread="0.11843"/>
                    <measurement group_id="O3" value="0.8489" spread="0.11648"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Health Related Quality of Life Scale (EQ-5D-5L)</title>
        <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1. 0 is better and 1 is worse.</description>
        <time_frame>28-35 days after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Investigational group1</title>
            <description>Spiral PDS Plus</description>
          </group>
          <group group_id="O2">
            <title>Investigational group2</title>
            <description>Spiral MONOCRYL Plus</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>PDS Plus or Monocryl Plus</description>
          </group>
        </group_list>
        <measure>
          <title>Health Related Quality of Life Scale (EQ-5D-5L)</title>
          <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1. 0 is better and 1 is worse.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9159" spread="0.10566"/>
                    <measurement group_id="O2" value="0.9024" spread="0.10738"/>
                    <measurement group_id="O3" value="0.9230" spread="0.10489"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary of EQ-5D VAS Score</title>
        <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100. 100 is best and 0 is worst.</description>
        <time_frame>5-7 Days after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Investigational group1</title>
            <description>Spiral PDS Plus</description>
          </group>
          <group group_id="O2">
            <title>Investigational group2</title>
            <description>Spiral MONOCRYL Plus</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>PDS Plus or Monocryl Plus</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of EQ-5D VAS Score</title>
          <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100. 100 is best and 0 is worst.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="160"/>
                <count group_id="O3" value="160"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="88.1" spread="10.02"/>
                    <measurement group_id="O2" value="87.7" spread="10.32"/>
                    <measurement group_id="O3" value="88.3" spread="9.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Summary of EQ-5D VAS Score</title>
        <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100.</description>
        <time_frame>28-35 Days after surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Investigational group1</title>
            <description>Spiral PDS Plus</description>
          </group>
          <group group_id="O2">
            <title>Investigational group2</title>
            <description>Spiral MONOCRYL Plus</description>
          </group>
          <group group_id="O3">
            <title>Control Group</title>
            <description>PDS Plus or Monocryl Plus</description>
          </group>
        </group_list>
        <measure>
          <title>Summary of EQ-5D VAS Score</title>
          <description>Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100.</description>
          <units>scores on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="160"/>
                <count group_id="O2" value="159"/>
                <count group_id="O3" value="158"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91.2" spread="8.95"/>
                    <measurement group_id="O2" value="91.7" spread="7.83"/>
                    <measurement group_id="O3" value="92.3" spread="7.88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>35 days</time_frame>
      <desc>AE is an untoward medical occurrence during the clinical study and which does not necessarily have a causal relationship with the study medical device.&#xD;
one subject didn't participate screen visit and randomize, but receive IP(group 2) treatment by mistake. investigator collect his safety information. so the Number of Participants at Risk of group 2 is one more than other rows.</desc>
      <group_list>
        <group group_id="E1">
          <title>Investigational Group 1</title>
          <description>Spiral PDS Plus</description>
        </group>
        <group group_id="E2">
          <title>Investigational Group 2</title>
          <description>Spiral MONOCRYL Plus</description>
        </group>
        <group group_id="E3">
          <title>Control groupEdit</title>
          <description>PDS Plus or Monocryl Plus</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>study protocol</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="161"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Supraventricular tachycardia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <description>General disorders and administration site conditions</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Papillary thyroid cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Breast adenoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Haemangioma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Metastatic lymphoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="161"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin oedema</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="162"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="161"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>study protocol</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="44" subjects_at_risk="162"/>
                <counts group_id="E2" subjects_affected="46" subjects_at_risk="161"/>
                <counts group_id="E3" subjects_affected="50" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Hypocalcaemia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="162"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="161"/>
                <counts group_id="E3" events="16" subjects_affected="16" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="30" subjects_affected="30" subjects_at_risk="162"/>
                <counts group_id="E2" events="32" subjects_affected="32" subjects_at_risk="161"/>
                <counts group_id="E3" events="31" subjects_affected="31" subjects_at_risk="162"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="28" subjects_affected="27" subjects_at_risk="162"/>
                <counts group_id="E2" events="26" subjects_affected="25" subjects_at_risk="161"/>
                <counts group_id="E3" events="29" subjects_affected="29" subjects_at_risk="162"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The disclosure restriction on the principal investigator(PI) is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than or equal to 60 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Xiaolei, Wang</name_or_title>
      <organization>Johnson &amp; Johnson Medical Shanghai Ltd.</organization>
      <phone>+86 21 33378749</phone>
      <email>xwang183@its.jnj.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/NCT03792737
org study id: ESC-201702
nct id: NCT03792737
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The primary objective of this study is to evaluate the efficacy and safety of two types of
      absorbable surgical sutures -- STRATAFIX Spiral PDS Knotless Plus Tissue Control Device and
      STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Device (hereinafter referred to as
      Spiral PDS Plus and Spiral MONOCRYL Plus) used in thyroid surgery to suture surgical
      incision.
This study adopts a multicenter, prospective, randomized controlled design. The study
      population are subjects who undergo thyroid surgery.

      Before the surgery, subjects are randomized in 1:1:1 ratio to the investigational group 1
      (using Spiral PDS Plus), investigational group 2 (using Spiral MONOCRYL Plus) and control
      group. See the table below for the specific suture levels, materials and techniques of each
      group.

      A blinded central imaging evaluation will be performed on the healing condition of surgical
      incision on Day 5-7 post-surgery. The subjects will be blinded to the type of suture used for
      wound closure.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Wound Healing Grade
time frame: 5-7days
description: Percentage of Participants with Grade A Healing of Surgical Incision
measure: Incision Closure Time
time frame: during surgery, an average of around 12 Mins
description: the time required from the first needle insertion for stitching ribbon muscles to the completion of intradermal suture (minutes)
measure: Postoperative Incisional Pain Score (Visual Analogue Scale, VAS)
time frame: 5-7 Days after Surgery and 28-35 Days after Surgery
description: For the postoperative incisional pain score, a score of 0 means no pain, and a score of 10 means unbearable: severely affects sleep with other symptoms, or passive position.
measure: Modified Hollander Wound Evaluation Scale - FAS
time frame: 28-35 days
description: Total cosmetic score. Assessed by Central Imaging evaluators using incision pictures to evaluate healing status. range is from 0 to 5, 0 is best and 5 is worst
measure: Health Related Quality of Life Scale (EQ-5D-5L)
time frame: 5-7 days after surgery
description: Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1, 0 is better and 1 is worse
measure: Health Related Quality of Life Scale (EQ-5D-5L)
time frame: 28-35 days after surgery
description: Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 1. 0 is better and 1 is worse.
measure: Summary of EQ-5D VAS Score
time frame: 5-7 Days after surgery
description: Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100. 100 is best and 0 is worst.
measure: Summary of EQ-5D VAS Score
time frame: 28-35 Days after surgery
description: Summary of European Quality of Life-5 Dimensions, 5 Levels Scale (EQ-5D-5L) Index Values by Follow-Up Visit - Full Analysis Set. it's to evaluate subjects Health related quality of life. rang is 0 to 100.
arm group label: Investigational group 1
arm group type: Experimental
description: Investigational group 1: Use the study device Spiral PDS Plus for continuous suture of the ribbon muscles, VICRYL Plus for interrupted suture of the platysma, and MONOCRYL Plus for continuous subcuticular suture.
arm group label: Investigational group 2
arm group type: Experimental
description: Investigational group 2: Use PDS Plus for continuous suture of the ribbon muscles, VICRYL Plus for interrupted suture of the platysma, and the study device Spiral MONOCRYL Plus for continuous subcuticular suture.
arm group label: Control group
arm group type: Active Comparator
description: Control group: Use the control device PDS Plus for continuous suture of the ribbon muscles, VICRYL Plus for interrupted suture of the platysma, and the control device MONOCRYL Plus continuous subcuticular suture.
intervention type: Device
intervention name: Spiral PDS Plus
description: The Spiral PDS Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral PDS Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
arm group label: Investigational group 1
intervention type: Device
intervention name: Spiral MONOCRYL Plus
description: The Spiral MONOCRYL Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral MONOCRYL Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
arm group label: Investigational group 2
intervention type: Device
intervention name: PDS Plus
description: PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.
arm group label: Control group
arm group label: Investigational group 2
intervention type: Device
intervention name: MONOCRYL Plus
description: MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.
arm group label: Control group
arm group label: Investigational group 1
intervention type: Device
intervention name: VICRYL Plus
description: VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.
arm group label: Control group
arm group label: Investigational group 1
arm group label: Investigational group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 69 Years
healthy volunteers: No
last name: Hao Zhang
role: Principal Investigator
affiliation: First Hospital of China Medical University
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country: China
responsible party type: Sponsor
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