<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/NCT03285542</url>
  </required_header>
  <id_info>
    <org_study_id>17-842</org_study_id>
    <nct_id>NCT03285542</nct_id>
  </id_info>
  <brief_title>Prospective Randomized Trial of Dermabond Prineo in Total Knee Arthroplasty</brief_title>
  <official_title>Prospective Randomized Trial of Dermabond Prineo Wound Closure System on Operating Room Time and Wound Closure Time 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>
      In this prospective pilot study examining the superficial closure during total knee&#xD;
      arthroplasty, active subjects will receive the STRATAFIX Spiral Knotless Tissue Control&#xD;
      Device for subcuticular closure in addition to DERMABOND PRINEO (Ethicon, Johnson and&#xD;
      Johnson, Somerville, New Jersey) system for dermal closure. The control subjects will receive&#xD;
      staples (standard-of-care).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system is a&#xD;
      unique two-part skin closure system that consists of: a 2-octyl cyanoacrylate topical skin&#xD;
      adhesive for proven strength and microbial protection in vitro, and a flexible, self-adhesive&#xD;
      polyester mesh for excellent approximation and healing. It is aimed to add strength and&#xD;
      protection when closing medium to long incisions. In addition, it is designed to replace the&#xD;
      use of subcuticular sutures or staples, with greater holding strength, with the potential to&#xD;
      reduce skin closure time.&#xD;
&#xD;
      Various studies have evaluated the outcomes of different closure devices, however, there are&#xD;
      no reports assessing the length of closure times using DERMABOND PRINEO (Ethicon, Johnson and&#xD;
      Johnson, Somerville, New Jersey) Knotless Tissue Control Devices during superficial closure&#xD;
      in orthopaedic surgery. Huemer et al. (1) performed an observational study of 180 patients&#xD;
      who had 224 excisional body-contouring surgeries utilizing Dermabond Prineo for superficial&#xD;
      closure. Authors concluded that this closure type enables the surgeon to perform a quick and&#xD;
      smooth skin closure. However, 4 patients (1.8%) developed local allergic reactions, which&#xD;
      necessitated early removal and topical corticosteroid treatment. Parvizi et al.(2) performed&#xD;
      an open, prospective, randomized clinical study of superficial wound closure on 60 patients&#xD;
      undergoing abdominoplasty with either Dermabond Prineo or conventional superficial closure.&#xD;
      They found significantly lower price ($134.79 cheaper) and significantly better Hollander&#xD;
      Cosmesis Scale scores in Dermabond Prineo cohort. In addition, there was a significantly&#xD;
      better cosmetic outcome at 6 and 12 months after surgery. The use of Dermabond Prineo may be&#xD;
      able to decrease operative time and costs in other surgical fields, such as orthopedics.&#xD;
      Careful patient allergy history is necessary to avoid adhesive allergic reactions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Actual">June 30, 2019</completion_date>
  <primary_completion_date type="Actual">March 25, 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>Modified Hollander Cosmesis Scale</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>Scar evaluation scale is used to assess the long-term aesthetic or cosmetic appearance of scars.&#xD;
Scars were assigned 0 or 1 point each for the presence (1) or absence (0) of the following: (1) a width greater than 2 mm at any point of the scar; (2) a raised or depressed scar in relation to the surrounding normal skin; (3) red, blue, brown, or black discoloration of the scar relative to the surrounding normal skin; (4) any hatch marks on either side of the scar from previous sutures or staples; and (5) overall poor or ugly appearance. The total score was then derived by adding the scores on the individual items of the scar evaluation scale ranging from 0 (best) to 5 (worst).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Wound Complications</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>presence of superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction (Visual Analogue Scale)</measure>
    <time_frame>90 days postoperative</time_frame>
    <description>patient satisfaction with wound appearance, measured by marking on a line of 100 mm, with 0 mm being low and 100 mm being high.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Wound Heal</condition>
  <arm_group>
    <arm_group_label>DERMABOND GROUP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CONTROL GROUP</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>DERMABOND</intervention_name>
    <description>DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)</description>
    <arm_group_label>DERMABOND GROUP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Staples</intervention_name>
    <description>staples for skin closure</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 nonpregnant (negative pregnancy test results at the&#xD;
             baseline/randomization visit) and nonlactating.&#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 (ie. 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>April 2021</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 18, 2017</study_first_posted>
  <results_first_submitted>October 30, 2020</results_first_submitted>
  <results_first_submitted_qc>October 30, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 24, 2020</results_first_posted>
  <last_update_submitted>April 19, 2021</last_update_submitted>
  <last_update_submitted_qc>April 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2021</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>adhesive</keyword>
  <keyword>total knee arthroplasty</keyword>
  <keyword>wound</keyword>
  <keyword>closure</keyword>
  <keyword>time</keyword>
  <keyword>barbed suture</keyword>
  <keyword>knoteless suture</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <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>May 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/42/NCT03285542/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DERMABOND GROUP</title>
          <description>For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.&#xD;
DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)</description>
        </group>
        <group group_id="P2">
          <title>CONTROL GROUP</title>
          <description>For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples&#xD;
Staples: staples for skin closure</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>
      <group_list>
        <group group_id="B1">
          <title>DERMABOND GROUP</title>
          <description>For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.&#xD;
DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)</description>
        </group>
        <group group_id="B2">
          <title>CONTROL GROUP</title>
          <description>For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples&#xD;
Staples: staples for skin closure</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="62" spread="8"/>
                    <measurement group_id="B2" value="62" spread="7"/>
                    <measurement group_id="B3" value="62" spread="8"/>
                  </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="22"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="23"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Modified Hollander Cosmesis Scale</title>
        <description>Scar evaluation scale is used to assess the long-term aesthetic or cosmetic appearance of scars.&#xD;
Scars were assigned 0 or 1 point each for the presence (1) or absence (0) of the following: (1) a width greater than 2 mm at any point of the scar; (2) a raised or depressed scar in relation to the surrounding normal skin; (3) red, blue, brown, or black discoloration of the scar relative to the surrounding normal skin; (4) any hatch marks on either side of the scar from previous sutures or staples; and (5) overall poor or ugly appearance. The total score was then derived by adding the scores on the individual items of the scar evaluation scale ranging from 0 (best) to 5 (worst).</description>
        <time_frame>90 days postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DERMABOND GROUP</title>
            <description>For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.&#xD;
DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)</description>
          </group>
          <group group_id="O2">
            <title>CONTROL GROUP</title>
            <description>For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples&#xD;
Staples: staples for skin closure</description>
          </group>
        </group_list>
        <measure>
          <title>Modified Hollander Cosmesis Scale</title>
          <description>Scar evaluation scale is used to assess the long-term aesthetic or cosmetic appearance of scars.&#xD;
Scars were assigned 0 or 1 point each for the presence (1) or absence (0) of the following: (1) a width greater than 2 mm at any point of the scar; (2) a raised or depressed scar in relation to the surrounding normal skin; (3) red, blue, brown, or black discoloration of the scar relative to the surrounding normal skin; (4) any hatch marks on either side of the scar from previous sutures or staples; and (5) overall poor or ugly appearance. The total score was then derived by adding the scores on the individual items of the scar evaluation scale ranging from 0 (best) to 5 (worst).</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>
                  <title>Total score 0</title>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Total score 1</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Total score 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Total score 3</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Total score 4</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Total score 5</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Wound Complications</title>
        <description>presence of 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>DERMABOND GROUP</title>
            <description>For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.&#xD;
DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)</description>
          </group>
          <group group_id="O2">
            <title>CONTROL GROUP</title>
            <description>For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples&#xD;
Staples: staples for skin closure</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Wound Complications</title>
          <description>presence of 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="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction (Visual Analogue Scale)</title>
        <description>patient satisfaction with wound appearance, measured by marking on a line of 100 mm, with 0 mm being low and 100 mm being high.</description>
        <time_frame>90 days postoperative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DERMABOND GROUP</title>
            <description>For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.&#xD;
DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)</description>
          </group>
          <group group_id="O2">
            <title>CONTROL GROUP</title>
            <description>For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples&#xD;
Staples: staples for skin closure</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction (Visual Analogue Scale)</title>
          <description>patient satisfaction with wound appearance, measured by marking on a line of 100 mm, with 0 mm being low and 100 mm being high.</description>
          <units>millimeters</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="29"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97.6" spread="3.2"/>
                    <measurement group_id="O2" value="82.6" spread="12.8"/>
                  </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>DERMABOND GROUP</title>
          <description>For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.&#xD;
DERMABOND: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)</description>
        </group>
        <group group_id="E2">
          <title>CONTROL GROUP</title>
          <description>For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples&#xD;
Staples: staples for skin closure</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Non-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="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="2" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Wound dehiscence</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Superficial surgical site infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="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>Principal Investigators are NOT 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>216-445-3843</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/NCT03285542
org study id: 17-842
nct id: NCT03285542
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
In this prospective pilot study examining the superficial closure during total knee
      arthroplasty, active subjects will receive the STRATAFIX Spiral Knotless Tissue Control
      Device for subcuticular closure in addition to DERMABOND PRINEO (Ethicon, Johnson and
      Johnson, Somerville, New Jersey) system for dermal closure. The control subjects will receive
      staples (standard-of-care).
The DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system is a
      unique two-part skin closure system that consists of: a 2-octyl cyanoacrylate topical skin
      adhesive for proven strength and microbial protection in vitro, and a flexible, self-adhesive
      polyester mesh for excellent approximation and healing. It is aimed to add strength and
      protection when closing medium to long incisions. In addition, it is designed to replace the
      use of subcuticular sutures or staples, with greater holding strength, with the potential to
      reduce skin closure time.

      Various studies have evaluated the outcomes of different closure devices, however, there are
      no reports assessing the length of closure times using DERMABOND PRINEO (Ethicon, Johnson and
      Johnson, Somerville, New Jersey) Knotless Tissue Control Devices during superficial closure
      in orthopaedic surgery. Huemer et al. (1) performed an observational study of 180 patients
      who had 224 excisional body-contouring surgeries utilizing Dermabond Prineo for superficial
      closure. Authors concluded that this closure type enables the surgeon to perform a quick and
      smooth skin closure. However, 4 patients (1.8%) developed local allergic reactions, which
      necessitated early removal and topical corticosteroid treatment. Parvizi et al.(2) performed
      an open, prospective, randomized clinical study of superficial wound closure on 60 patients
      undergoing abdominoplasty with either Dermabond Prineo or conventional superficial closure.
      They found significantly lower price ($134.79 cheaper) and significantly better Hollander
      Cosmesis Scale scores in Dermabond Prineo cohort. In addition, there was a significantly
      better cosmetic outcome at 6 and 12 months after surgery. The use of Dermabond Prineo may be
      able to decrease operative time and costs in other surgical fields, such as orthopedics.
      Careful patient allergy history is necessary to avoid adhesive allergic reactions.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Modified Hollander Cosmesis Scale
time frame: 90 days postoperative
description: Scar evaluation scale is used to assess the long-term aesthetic or cosmetic appearance of scars.
Scars were assigned 0 or 1 point each for the presence (1) or absence (0) of the following: (1) a width greater than 2 mm at any point of the scar; (2) a raised or depressed scar in relation to the surrounding normal skin; (3) red, blue, brown, or black discoloration of the scar relative to the surrounding normal skin; (4) any hatch marks on either side of the scar from previous sutures or staples; and (5) overall poor or ugly appearance. The total score was then derived by adding the scores on the individual items of the scar evaluation scale ranging from 0 (best) to 5 (worst).
measure: Number of Patients With Wound Complications
time frame: 90 days postoperative
description: presence of superficial wound infection, deep wound infection, periprosthetic joint infection, wound hematoma, and wound dehiscence.
measure: Patient Satisfaction (Visual Analogue Scale)
time frame: 90 days postoperative
description: patient satisfaction with wound appearance, measured by marking on a line of 100 mm, with 0 mm being low and 100 mm being high.
arm group label: DERMABOND GROUP
arm group type: Active Comparator
description: For the active arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, 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 STRATAFIX Spiral Knotless Tissue Control Device in addition to DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey) system for dermal closure.
arm group label: CONTROL GROUP
arm group type: Placebo Comparator
description: For the control arm of the study, the arthrotomy (deep layer) is repaired using number 1 Vicryl, the subcutaneous layer will be then closed with simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl), followed by skin closure with staples
intervention type: Device
intervention name: DERMABOND
description: DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)
arm group label: DERMABOND GROUP
intervention type: Device
intervention name: Staples
description: staples for skin closure
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
mesh term: Wounds and Injuries
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: 