<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/NCT03285529</url>
  </required_header>
  <id_info>
    <org_study_id>17-841</org_study_id>
    <nct_id>NCT03285529</nct_id>
  </id_info>
  <brief_title>The Use of STRATAFIX Suture Device Compared to Standard-of-care for Deep Tissue Closure in Total Knee Arthroplasty</brief_title>
  <official_title>The Use of STRATAFIX Suture Device Compared to Standard-of-care for Deep Tissue Closure in Total Knee Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Cleveland Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Cleveland Clinic</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>
      The STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New Jersey) Knotless Tissue Control&#xD;
      suture device is a barbed suture that uses anchor technology to securely engage with the soft&#xD;
      tissues while also eliminating the need for knots. The anchors, or barbs, are pressed out of&#xD;
      the device core or formed within the core in a geometric pattern and arranged in a tapered&#xD;
      manner to allow the device to pass through tissue in the direction toward the needle during&#xD;
      closure. These knotless tissue control devices are deployed using a continuous technique,&#xD;
      which is anticipated to be faster and more cost-effective than interrupted suturing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Preclinical and biomechanical studies have demonstrated efficacy in cosmetic skin and deep&#xD;
      tissue closures.[1], [2] In addition, barbed sutures have been shown to provide water-tight&#xD;
      closure and wound strength comparable to or superior to closure with conventional sutures.&#xD;
      Many comparative studies have been published contrasting barbed sutures to conventional&#xD;
      closure techniques in multiple surgical fields. [3], [4] Various studies have evaluated the&#xD;
      outcomes of different barbed suture devices, however there are no reports assessing the&#xD;
      length of closure times using STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New&#xD;
      Jersey) Knotless Tissue Control Devices during deep closure in total hip arthroplasty.&#xD;
      Stephens et al. [5] performed a prospective randomized study of 500 total knee arthroplasty&#xD;
      patients who received either barbed suture (250) or conventional sutures (250) for deep&#xD;
      closure of the surgical wound. The mean operating time was significantly shorter in the&#xD;
      barbed group as compared to conventional group (64.3 vs 68.1 minutes, p=&lt;0.001). In a study&#xD;
      of 80 TKA (61 barbed, 19 conventional deep sutures) and 54 THA patients (37 barbed, 17&#xD;
      conventional deep sutures), Smith et al. [6] found significantly shorter closure time in the&#xD;
      barbed suture group (16.78 vs. 26.5 minutes, p&lt;0.001). One study reports one the use of&#xD;
      Stratfix suture for intracorporeal suturing in myomectomy. Giampaolino et al. [7] performed a&#xD;
      prospective randomized study on 47 patients and evaluated the mean operative time for&#xD;
      laparoscopic posterior myomectomy using Stratafix or conventional suture for intracorporeal&#xD;
      suturing. There was a significant decrease in mean operative time associated with use of&#xD;
      Stratafix suture as compared to conventional suture (66.3 vs 73 minutes, p=0.005).&#xD;
&#xD;
      This prospective randomized single-center study will examine the outcomes, mainly closure&#xD;
      time, of deep closure during total knee arthroplasty using the STRATAFIX Symmetric PDS Plus&#xD;
      (Ethicon, Johnson and Johnson, Somerville, New Jersey) barbed suture compared to interrupted&#xD;
      VICRYL suture (Ethicon, Johnson and Johnson, Somerville, New Jersey).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 26, 2017</start_date>
  <completion_date type="Actual">May 31, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Close, Minutes</measure>
    <time_frame>Day of surgery</time_frame>
    <description>Time from first needle insertion to complete skin closure per protocol</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Wound Complications</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Wound; Knee</condition>
  <arm_group>
    <arm_group_label>STRATAFIX GROUP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL GROUP</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>STRATIFIX</intervention_name>
    <description>STRATIFIX symmetric PDS Plus; Stratifix knotless suture</description>
    <arm_group_label>STRATAFIX GROUP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>VICRYL</intervention_name>
    <description>Vicryl #1</description>
    <arm_group_label>CONTROL GROUP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Males and females, between the ages of 18 to 80 years at the time of signing the&#xD;
             informed consent document.&#xD;
&#xD;
          2. Understand and voluntarily sign an informed consent document prior to any&#xD;
             study-related assessments/procedures are conducted.&#xD;
&#xD;
          3. Able to adhere to the study visit schedule and other protocol requirements.&#xD;
&#xD;
          4. Able to fluently speak and understand the local language&#xD;
&#xD;
          5. If female, is non-pregnant (negative pregnancy test results at the&#xD;
             baseline/randomization visit) and non-lactating.&#xD;
&#xD;
          6. End-stage osteoarthritis patients planning to undergo primary total knee arthroplasty&#xD;
&#xD;
          7. BMI less than 40 kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. BMI greater than or equal to 40 kg/m2.&#xD;
&#xD;
          2. History of known bleeding disorder.&#xD;
&#xD;
          3. History of medical co-morbidity that may result in poor wound healing (i.e. diabetes&#xD;
             mellitus, peripheral vascular disease).&#xD;
&#xD;
          4. Patients &lt;18 or &gt;80 years of age.&#xD;
&#xD;
          5. Patients who are prisoners.&#xD;
&#xD;
          6. Mentally unable to sign informed consent.&#xD;
&#xD;
          7. Has an uncontrolled illness that, in the opinion of the investigator, is likely to&#xD;
             cause the patient to be withdrawn from the trial or would otherwise interfere with&#xD;
             interpreting the results of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Viktor Krebs, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Cleveland Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>August 17, 2020</results_first_submitted>
  <results_first_submitted_qc>October 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 19, 2020</results_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Cleveland Clinic</investigator_affiliation>
    <investigator_full_name>Viktor Krebs, M.D.</investigator_full_name>
    <investigator_title>Vice Chairman - Adult Reconstruction</investigator_title>
  </responsible_party>
  <keyword>barbed suture</keyword>
  <keyword>knoteless suture</keyword>
  <keyword>total knee arthroplasty</keyword>
  <keyword>wound</keyword>
  <keyword>closure</keyword>
  <keyword>time</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No data will be shared with other researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 17, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/29/NCT03285529/Prot_SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>STRATAFIX GROUP</title>
          <description>STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive&#xD;
STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture</description>
        </group>
        <group group_id="P2">
          <title>CONTROL GROUP</title>
          <description>The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.&#xD;
VICRYL: Vicryl #1</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>total knee arthroplasty patients</population>
      <group_list>
        <group group_id="B1">
          <title>STRATAFIX GROUP</title>
          <description>STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive&#xD;
STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture</description>
        </group>
        <group group_id="B2">
          <title>CONTROL GROUP</title>
          <description>The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.&#xD;
VICRYL: Vicryl #1</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="60"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="68" spread="7"/>
                    <measurement group_id="B2" value="66" spread="7"/>
                    <measurement group_id="B3" value="67" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Wound length</title>
          <units>centimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="30"/>
                    <count group_id="B2" value="30"/>
                    <count group_id="B3" value="60"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17.1" spread="2.0"/>
                    <measurement group_id="B2" value="16.1" spread="1.3"/>
                    <measurement group_id="B3" value="16.6" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Close, Minutes</title>
        <description>Time from first needle insertion to complete skin closure per protocol</description>
        <time_frame>Day of surgery</time_frame>
        <group_list>
          <group group_id="O1">
            <title>STRATAFIX GROUP</title>
            <description>STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive&#xD;
STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture</description>
          </group>
          <group group_id="O2">
            <title>CONTROL GROUP</title>
            <description>The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.&#xD;
VICRYL: Vicryl #1</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Close, Minutes</title>
          <description>Time from first needle insertion to complete skin closure per protocol</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="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" spread="0.08"/>
                    <measurement group_id="O2" value="28" spread="0.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Wound Complications</title>
        <description>superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.</description>
        <time_frame>90 days postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>STRATAFIX GROUP</title>
            <description>STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive&#xD;
STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture</description>
          </group>
          <group group_id="O2">
            <title>CONTROL GROUP</title>
            <description>The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.&#xD;
VICRYL: Vicryl #1</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Wound Complications</title>
          <description>superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="30"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>90 days postoperative</time_frame>
      <group_list>
        <group group_id="E1">
          <title>STRATAFIX GROUP</title>
          <description>STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive&#xD;
STRATIFIX: STRATIFIX symmetric PDS Plus; Stratifix knotless suture</description>
        </group>
        <group group_id="E2">
          <title>CONTROL GROUP</title>
          <description>The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.&#xD;
VICRYL: Vicryl #1</description>
        </group>
      </group_list>
      <serious_events>
        <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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="3" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Superficial surgical site infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Stitch abscess</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Wound discharge</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Wound hematoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Viktor Krebs</name_or_title>
      <organization>Cleveland Clinic</organization>
      <phone>216-444-2600</phone>
      <email>krebsv@ccf.org</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/NCT03285529
org study id: 17-841
nct id: NCT03285529
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New Jersey) Knotless Tissue Control
      suture device is a barbed suture that uses anchor technology to securely engage with the soft
      tissues while also eliminating the need for knots. The anchors, or barbs, are pressed out of
      the device core or formed within the core in a geometric pattern and arranged in a tapered
      manner to allow the device to pass through tissue in the direction toward the needle during
      closure. These knotless tissue control devices are deployed using a continuous technique,
      which is anticipated to be faster and more cost-effective than interrupted suturing.
Preclinical and biomechanical studies have demonstrated efficacy in cosmetic skin and deep
      tissue closures.[1], [2] In addition, barbed sutures have been shown to provide water-tight
      closure and wound strength comparable to or superior to closure with conventional sutures.
      Many comparative studies have been published contrasting barbed sutures to conventional
      closure techniques in multiple surgical fields. [3], [4] Various studies have evaluated the
      outcomes of different barbed suture devices, however there are no reports assessing the
      length of closure times using STRATAFIX (Ethicon, Johnson and Johnson, Somerville, New
      Jersey) Knotless Tissue Control Devices during deep closure in total hip arthroplasty.
      Stephens et al. [5] performed a prospective randomized study of 500 total knee arthroplasty
      patients who received either barbed suture (250) or conventional sutures (250) for deep
      closure of the surgical wound. The mean operating time was significantly shorter in the
      barbed group as compared to conventional group (64.3 vs 68.1 minutes, p=<0.001). In a study
      of 80 TKA (61 barbed, 19 conventional deep sutures) and 54 THA patients (37 barbed, 17
      conventional deep sutures), Smith et al. [6] found significantly shorter closure time in the
      barbed suture group (16.78 vs. 26.5 minutes, p<0.001). One study reports one the use of
      Stratfix suture for intracorporeal suturing in myomectomy. Giampaolino et al. [7] performed a
      prospective randomized study on 47 patients and evaluated the mean operative time for
      laparoscopic posterior myomectomy using Stratafix or conventional suture for intracorporeal
      suturing. There was a significant decrease in mean operative time associated with use of
      Stratafix suture as compared to conventional suture (66.3 vs 73 minutes, p=0.005).

      This prospective randomized single-center study will examine the outcomes, mainly closure
      time, of deep closure during total knee arthroplasty using the STRATAFIX Symmetric PDS Plus
      (Ethicon, Johnson and Johnson, Somerville, New Jersey) barbed suture compared to interrupted
      VICRYL suture (Ethicon, Johnson and Johnson, Somerville, New Jersey).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Time to Close, Minutes
time frame: Day of surgery
description: Time from first needle insertion to complete skin closure per protocol
measure: Number of Participants With Wound Complications
time frame: 90 days postoperative
description: superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.
arm group label: STRATAFIX GROUP
arm group type: Active Comparator
description: STRATIFIX symmetric PDS Plus #1 will be used to close the capsule following total knee arthroplasty. The subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by closure of the subcutaneous layer using a number 2-0 monofilament absorbable suture with inverted interrupted knots (Monocryl) followed by the use of steri-strips and adhesive
arm group label: CONTROL GROUP
arm group type: Placebo Comparator
description: The arthrotomy (deep layer) is repaired using Vicryl #1 followed by closure of the intermediate layer with a 2-0 Vicryl and a subcutaneous layer with a 2-0 Monocryl followed by steri-strips and adhesive, following total knee arthroplasty.
intervention type: Device
intervention name: STRATIFIX
description: STRATIFIX symmetric PDS Plus; Stratifix knotless suture
arm group label: STRATAFIX GROUP
intervention type: Device
intervention name: VICRYL
description: Vicryl #1
arm group label: CONTROL GROUP
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Viktor Krebs, MD
role: Principal Investigator
affiliation: The Cleveland Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The Cleveland Clinic
investigator full name: Viktor Krebs, M.D.
investigator title: Vice Chairman - Adult Reconstruction
sharing ipd: No
ipd description: No data will be shared with other researchers.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 