<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/NCT03305887</url>
  </required_header>
  <id_info>
    <org_study_id>ESC-16-001</org_study_id>
    <nct_id>NCT03305887</nct_id>
  </id_info>
  <brief_title>Symmetric on Total Knee Arthroplasty (TKA)</brief_title>
  <acronym>SFX</acronym>
  <official_title>A Prospective, Multicenter, Randomized Controlled Study to Evaluate the Wound Closure Efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device Compared to Conventional Sutures in Total Knee Arthroplasty (TKA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johnson &amp; Johnson Medical, China</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Second Affiliated Hospital of Xi'an Jiaotong University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Second Affiliated Hospital, School of Medicine, Zhejiang University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>China-Japan Union Hospital, Jilin University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nanfang Hospital, Southern Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tongji Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Chinese PLA General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The First Affiliated Hospital with Nanjing Medical University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Johnson &amp; Johnson Medical, China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound&#xD;
      closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device&#xD;
      (STRATAFIX Symmetric PDS Plus) compared to conventional sutures in total knee arthroplasty&#xD;
      (TKA)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of this prospective, randomized controlled study is to evaluate the&#xD;
      wound closure efficiency of STRATAFIX Symmetric PDS Plus compared to conventional sutures in&#xD;
      patients undergoing TKA. For the purpose of this study, wound closure efficiency is defined&#xD;
      as the total time required to close the surgical incisions in patients undergoing TKA&#xD;
      procedures using STRATAFIX Symmetric PDS Plus compared to those using traditional sutures.&#xD;
      Secondary objectives will include the evaluation of differences in overall surgical procedure&#xD;
      time, operating room (OR) time, length of stay, procedure costs, quality of life measures&#xD;
      including pain, and range of motion (ROM). In addition, the difference in the safety profiles&#xD;
      for both wound closure procedures will be evaluated through the analysis of the incidence of&#xD;
      wound complications including dehiscence, wound infections, and other adverse events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 12, 2017</start_date>
  <completion_date type="Actual">May 21, 2018</completion_date>
  <primary_completion_date type="Actual">April 13, 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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Suturing Time</measure>
    <time_frame>During Surgery</time_frame>
    <description>The total time required to close the surgical incisions between treatment groups.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">184</enrollment>
  <condition>Wound Closure</condition>
  <arm_group>
    <arm_group_label>Barbed suture group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The deep layer and the intermediate layer will be repaired and closed by using one &quot;STRATAFIX™ Symmetric&quot; Knotless Tissue suture respectively. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional suture group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>VICRYL® Plus sutures will be used to close the deep and the intermediate layers with interrupted suturing manner. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>&quot;STRATAFIX™ Symmetric&quot; Knotless Tissue</intervention_name>
    <description>This devices will be used in deep and intermediate layers of barbed suture group.</description>
    <arm_group_label>Barbed suture group</arm_group_label>
    <other_name>STRATAFIX Symmetric</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VICRYL® PLUS</intervention_name>
    <description>This devices will be used in deep and intermediate layers of conventional suture group.</description>
    <arm_group_label>Conventional suture group</arm_group_label>
    <other_name>Polyglactin 910</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>&quot;STRATAFIX Spiral&quot; sutures</intervention_name>
    <description>This devices will be used in intradermal layer of both barbed suture and conventional suture group.</description>
    <arm_group_label>Barbed suture group</arm_group_label>
    <arm_group_label>Conventional suture group</arm_group_label>
    <other_name>Spiral</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DERMABOND™ Advance™ Skin Closure System</intervention_name>
    <description>This devices will be used in skin layer of both barbed suture and conventional suture group.</description>
    <arm_group_label>Barbed suture group</arm_group_label>
    <arm_group_label>Conventional suture group</arm_group_label>
    <other_name>DERMABOND</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is ≥ 18 years and &lt; 80 years of age;&#xD;
&#xD;
          2. Patient with osteoarthritis is scheduled to undergo elective unilateral TKA;&#xD;
&#xD;
          3. Patient is willing to participate in the study, comply with study requirements,&#xD;
             follow-up schedule, and give written informed consent; and&#xD;
&#xD;
          4. Patient agrees not to schedule any additional elective surgical procedures until&#xD;
             participation in this study is complete.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Female patient who is pregnant or lactating at the time of screening;&#xD;
&#xD;
          2. Patient has a Body Mass Index (BMI) &gt; 40 kg/m2;&#xD;
&#xD;
          3. Patient is not able to walk independently (inability to walk at least 10 consecutive&#xD;
             meters without a walking aid);&#xD;
&#xD;
          4. Patient has had a surgical intervention during the past 30 days for treatment of&#xD;
             painful joint or its underlying etiology;&#xD;
&#xD;
          5. Patient has had previous open surgeries on the affected joint other than arthroscopy;&#xD;
&#xD;
          6. Patient has active infectious collagen diseases (i.e. scleroderma) or any other&#xD;
             condition that would interfere with wound healing;&#xD;
&#xD;
          7. Patient is allergic to poly (p-dioxanone), triclosan (IRGACARE®* MP) or D&amp;C Violet No.&#xD;
             2;&#xD;
&#xD;
          8. Patient has diabetes with poor control, defined as fasting plasma glucose (FPG) ≥ 10.0&#xD;
             mmol/L;&#xD;
&#xD;
          9. Patient has a history of immunosuppressive drug use, including steroids, within the&#xD;
             last 6 months;&#xD;
&#xD;
         10. Patient has undergone chemotherapy or radiation within the last 6 months prior to&#xD;
             study enrollment or is scheduled to do so during the study period;&#xD;
&#xD;
         11. Patient has known personal or family history of keloid formation or hypertrophy;&#xD;
&#xD;
         12. Patient has other dermatologic conditions known to impair wound healing;&#xD;
&#xD;
         13. Patient is participating in any other investigational drug (within 30 days or 5&#xD;
             half-lives of an investigational drug) or device study;&#xD;
&#xD;
         14. Patient has any physical or psychological condition which would impair study&#xD;
             participation; and&#xD;
&#xD;
         15. Patient is judged unsuitable for study participation by the investigator for any other&#xD;
             reason.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patty Schleckser</last_name>
    <role>Study Director</role>
    <affiliation>Ethicon, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese PLA general hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NanFang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tongji Hospital affiliated Tongji medical college huazhonguniversity of science&amp;technology</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jiangsu province hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jilin University Chinese Japanese Friendship Hospital</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130033</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>second affiliated hospital of Xi'an Jiaotong university</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710004</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 13, 2017</study_first_submitted>
  <study_first_submitted_qc>October 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 10, 2017</study_first_posted>
  <results_first_submitted>November 18, 2019</results_first_submitted>
  <results_first_submitted_qc>December 27, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">January 13, 2020</results_first_posted>
  <last_update_submitted>December 27, 2019</last_update_submitted>
  <last_update_submitted_qc>December 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TKA</keyword>
  <keyword>Barbed suture</keyword>
  <keyword>Surgical time</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <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>April 17, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03305887/SAP_000.pdf</document_url>
    </provided_document>
    <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>May 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/87/NCT03305887/Prot_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>STRATAFIX Symmetric PDS Plus</title>
          <description>an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone)</description>
        </group>
        <group group_id="P2">
          <title>Conventional Sutures</title>
          <description>Conventional Sutures is VICRYL Plus(Polyglactin 910)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="91"/>
                <participants group_id="P2" count="93"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="83"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All efficacy endpoints will be summarized descriptively by treatment group. The continuous variables will be summarized descriptively by number of subjects, mean, standard deviation, minimum, and maximum. Categorical data will be summarized descriptively by frequencies along with the associated percentages.</population>
      <group_list>
        <group group_id="B1">
          <title>STRATAFIX Symmetric PDS Plus</title>
          <description>an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone)</description>
        </group>
        <group group_id="B2">
          <title>Conventional Sutures</title>
          <description>Conventional Sutures is VICRYL Plus(Polyglactin 910)</description>
        </group>
        <group group_id="B3">
          <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="91"/>
            <count group_id="B2" value="93"/>
            <count group_id="B3" value="184"/>
          </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="119"/>
                  </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="70"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="138"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="25"/>
                    <measurement group_id="B3" value="46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                    <measurement group_id="B2" value="93"/>
                    <measurement group_id="B3" value="184"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Suturing Time</title>
        <description>The total time required to close the surgical incisions between treatment groups.</description>
        <time_frame>During Surgery</time_frame>
        <population>total 184 patients enrolled in this study, and 5 patients have no suture time, because they withdrawn from study before surgery or violated protocol, etc.</population>
        <group_list>
          <group group_id="O1">
            <title>STRATAFIX Symmetric PDS Plus</title>
            <description>an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone)</description>
          </group>
          <group group_id="O2">
            <title>Conventional Sutures</title>
            <description>Conventional Sutures is VICRYL Plus(Polyglactin 910)</description>
          </group>
        </group_list>
        <measure>
          <title>Suturing Time</title>
          <description>The total time required to close the surgical incisions between treatment groups.</description>
          <population>total 184 patients enrolled in this study, and 5 patients have no suture time, because they withdrawn from study before surgery or violated protocol, etc.</population>
          <units>minuts</units>
          <param>Mean</param>
          <dispersion>97.5% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.516" lower_limit="3.083" upper_limit="30.200"/>
                    <measurement group_id="O2" value="20.864" lower_limit="10.267" upper_limit="43.617"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>42 days</time_frame>
      <desc>An Adverse Events (AE) is defined as any untoward medical occurrence, regardless of its relationship to the study device (study suture) or the study procedure (Total Knee Arthoplasty). An untoward medical occurrence includes any new, undesirable medical experience or worsening of a pre-existing condition, which occurs at any point from the surgery to Final Visit.</desc>
      <group_list>
        <group group_id="E1">
          <title>STRATAFIX Symmetric PDS Plus</title>
          <description>an antibacterial (polydioxanone) monofilament, synthetic absorbable device prepared from polydioxanone (p-dioxanone) total 90 patients had been collected Adverse Events(AE) related data, and 1 patient has no data in this group.</description>
        </group>
        <group group_id="E2">
          <title>Conventional Sutures</title>
          <description>Conventional Sutures is VICRYL Plus (Polyglactin 910) total 89 patients had been collected Adverse Events(AE) related data, and 4 patient has no AE data in Conventional Sutures group.</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="90"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Postoperative pain/postoperative exudation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Incision infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Pain after knee replacement</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Incision subcutaneous hemorrhage and Incision exudate</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>inflammatory reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</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="8" subjects_at_risk="90"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>white blood cell increment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>red blood cell decrement</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>monocytes increment</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>hypokalemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>hypoalbuminemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>drug fever</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Limb swelling （left）</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Hemorrhagic seepage of wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Tension vesicle around the wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>seepage of wound</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Hemorrhagic infiltration of wound</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>lower limb swelling</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="89"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>inflammatory reaction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Incision inflammation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="90"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Hemorrhagic seepage of wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </event>
              <event>
                <sub_title>Contagious eczema rash</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="90"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="89"/>
              </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/NCT03305887
org study id: ESC-16-001
nct id: NCT03305887
lead sponsor: 
collaborator: 
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has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
A post-marketing prospective, multicenter, randomized controlled study to evaluate the wound
      closure efficiency of STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device
      (STRATAFIX Symmetric PDS Plus) compared to conventional sutures in total knee arthroplasty
      (TKA)
The primary objective of this prospective, randomized controlled study is to evaluate the
      wound closure efficiency of STRATAFIX Symmetric PDS Plus compared to conventional sutures in
      patients undergoing TKA. For the purpose of this study, wound closure efficiency is defined
      as the total time required to close the surgical incisions in patients undergoing TKA
      procedures using STRATAFIX Symmetric PDS Plus compared to those using traditional sutures.
      Secondary objectives will include the evaluation of differences in overall surgical procedure
      time, operating room (OR) time, length of stay, procedure costs, quality of life measures
      including pain, and range of motion (ROM). In addition, the difference in the safety profiles
      for both wound closure procedures will be evaluated through the analysis of the incidence of
      wound complications including dehiscence, wound infections, and other adverse events.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Suturing Time
time frame: During Surgery
description: The total time required to close the surgical incisions between treatment groups.
arm group label: Barbed suture group
arm group type: Experimental
description: The deep layer and the intermediate layer will be repaired and closed by using one "STRATAFIX™ Symmetric" Knotless Tissue suture respectively. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation.
arm group label: Conventional suture group
arm group type: Active Comparator
description: VICRYL® Plus sutures will be used to close the deep and the intermediate layers with interrupted suturing manner. STRATAFIX Spiral sutures will be used to close the intradermal layer and the DERMABOND™ Advance™ Skin Closure System, a topical skin adhesive (TSA) will be applied to the skin surface to tissue approximation.
intervention type: Device
intervention name: "STRATAFIX™ Symmetric" Knotless Tissue
description: This devices will be used in deep and intermediate layers of barbed suture group.
arm group label: Barbed suture group
other name: STRATAFIX Symmetric
intervention type: Device
intervention name: VICRYL® PLUS
description: This devices will be used in deep and intermediate layers of conventional suture group.
arm group label: Conventional suture group
other name: Polyglactin 910
intervention type: Device
intervention name: "STRATAFIX Spiral" sutures
description: This devices will be used in intradermal layer of both barbed suture and conventional suture group.
arm group label: Barbed suture group
arm group label: Conventional suture group
other name: Spiral
intervention type: Device
intervention name: DERMABOND™ Advance™ Skin Closure System
description: This devices will be used in skin layer of both barbed suture and conventional suture group.
arm group label: Barbed suture group
arm group label: Conventional suture group
other name: DERMABOND
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
last name: Patty Schleckser
role: Study Director
affiliation: Ethicon, Inc.
facility: 
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country: China
responsible party type: Sponsor
sharing ipd: No
provided document: 
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participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 