<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/NCT02213510</url>
  </required_header>
  <id_info>
    <org_study_id>140718</org_study_id>
    <nct_id>NCT02213510</nct_id>
  </id_info>
  <brief_title>ZIPS Study - Zip Incision aPproximation vs. Suture</brief_title>
  <acronym>ZIPS</acronym>
  <official_title>A Prospective, Non-blinded, Randomized Controlled Post-market Study Designed to Compare the Use of the Zip Surgical Skin Closure Device Versus Conventional Sutures for Skin Closure in Subjects Who Undergo a CIED Procedure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Diego</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ZipLine Medical Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Diego</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called &quot;Zip&#xD;
      Surgical Skin Closure&quot; to replace sutures, staples and glue for closure of the skin layer for&#xD;
      surgical incisions or laceration repair. The study will be comparing the Zip Surgical Skin&#xD;
      Closure to standard sutures in patients undergoing cardiovascular implantable electronic&#xD;
      device (CIED) procedures on outcomes including closure time, cosmetic appearance of resulting&#xD;
      scar, and overall cosmetic appearance of scar. The study will be following participants for 3&#xD;
      months following CIED procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called &quot;Zip&#xD;
      Surgical Skin Closure&quot; to replace sutures, staples and glue for closure of the skin layer for&#xD;
      surgical incisions or laceration repair. The device is designed to provide closure speed&#xD;
      superior to sutures, while resulting in a suture-like cosmetic outcome.The ZIPS study is a&#xD;
      randomized, clinical trial comparing outcomes of procedures that use the Zip Surgical Skin&#xD;
      Closure device with the outcomes of procedures that use stitches. The Zip Surgical Skin&#xD;
      Closure is not an investigational device and is currently used in hospital across the United&#xD;
      States. The Zip Surgical Skin Closure is a non-invasive (in other words, does not pierce the&#xD;
      skin or enter into the wound) device to hold skin closed while healing can occur. It adheres&#xD;
      to the skin close to the incision and uses adjustable straps to hold the incision closed. It&#xD;
      is typically worn on the skin for 7-14 days and is removed by peeling from the skin. Patients&#xD;
      will be randomized to either Zip Surgical Skin Closure or sutures, in addition to dissolvable&#xD;
      sutures for the deeper layers, for surgical procedures for cardiovascular implantable&#xD;
      electronic devices (CIED) i.e. pacemakers or defibrillators. Both of these closure techniques&#xD;
      are considered standard of care at this facility and are not themselves experimental.&#xD;
      However, the goal of this experimental study is to see if there are any significant&#xD;
      differences between the two closure methods, in a controlled study environment.&#xD;
&#xD;
      Since the Zip Surgical Skin Closure device is relatively new to the market, there is a&#xD;
      limited amount of information available describing the experience of patients and doctors&#xD;
      using the device. In this study, the investigators will be looking to compare the Zip&#xD;
      Surgical Skin Closure and stitches methods for the time necessary for the surgeon to close&#xD;
      the incision, cosmetic appearance of the resulting scar, and satisfaction of you and your&#xD;
      surgeon. The investigators will also be monitoring both study groups for occurrence of any&#xD;
      adverse (unfavorable) events. Patients will be followed for a total of 3 months for this&#xD;
      study. All study visits align with standard of care follow up for post-implantation of CIED.&#xD;
      Non-identifiable pictures will be obtained of the scar during follow up and both patients and&#xD;
      surgeons will complete questionnaires indicating their experience and satisfaction with the&#xD;
      either skin closure method.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall Closure Time</measure>
    <time_frame>2 weeks</time_frame>
    <description>Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)</measure>
    <time_frame>3 Months</time_frame>
    <description>Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgeon Wound Evaluation Scale (WES)</measure>
    <time_frame>2 weeks</time_frame>
    <description>At 2 weeks post-procedure, the Wound Evaluation Scale was measured. The scale is based from 0 (representing normal skin) to 100 (representing a poor scar).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon Evaluation Based on the Wound Evaluation Scale (WES)</measure>
    <time_frame>3 Months</time_frame>
    <description>The surgeon will complete an assessment of the following:&#xD;
Closure Method Satisfaction&#xD;
Scar Satisfaction&#xD;
Wound Healing as judged by Wound Evaluation Scale&#xD;
Scale rated on 1 (least favorable) to 6 (most favorable)&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon Satisfaction With Scar</measure>
    <time_frame>3 months</time_frame>
    <description>At 3 months post-procedure, the surgeon evaluated their satisfaction on a scale from 1 to 5, 5 being the least favorable.&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Comfort</measure>
    <time_frame>2 weeks</time_frame>
    <description>At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Satisfaction With Scar</measure>
    <time_frame>3 months</time_frame>
    <description>Patient will complete questionnaires that includes assessments of the following:&#xD;
Pain&#xD;
Closure Method Comfort&#xD;
Closure Method Satisfaction&#xD;
Scar Satisfaction&#xD;
Scar Satisfaction was measured on a scale from 1 (most satisfied) to 5 (least satisfied)&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Rating of Scar</measure>
    <time_frame>3 months</time_frame>
    <description>At 3 months post-procedure, patients were asked to rate their scar. Scale was measured from 0 (best scar) - 10 (worst scar)&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Incision Pain</measure>
    <time_frame>1 day (discharge)</time_frame>
    <description>At the discharge visit, patients evaluated their level of pain at the incision site based on a scale 1 (least pain) through 10 (worst pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Incision Pain</measure>
    <time_frame>2 weeks</time_frame>
    <description>At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Incision Pain</measure>
    <time_frame>3 months</time_frame>
    <description>Incision pain experienced by the patient was evaluated at 3 months post-procedure. This was evaluated on a scale of 0 (least pain) to 10 (worst pain).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Wound</condition>
  <condition>Cardiac Arrhythmia</condition>
  <arm_group>
    <arm_group_label>Zip Surgical Skin Closure device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Suture Closure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Zip Surgical Skin Closure Device</intervention_name>
    <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
    <arm_group_label>Zip Surgical Skin Closure device</arm_group_label>
    <other_name>Wound closure device</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Suture Closure</intervention_name>
    <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
    <arm_group_label>Standard Suture Closure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients 18 years of age and older;&#xD;
&#xD;
          2. Patients requiring suture closure for epidermal closure (after placement of cardiac&#xD;
             implantable electronic devices; including de novo and re implant generator changes);&#xD;
&#xD;
          3. Patients willing and able to complete study protocol&#xD;
&#xD;
          4. Life expectancy greater than 1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Known bleeding disorder not caused by medication;&#xD;
&#xD;
          2. Known personal or family history of keloid formation or scar hypertrophy;&#xD;
&#xD;
          3. Known allergy or hypersensitivity to non-latex skin adhesives;&#xD;
&#xD;
          4. Atrophic skin deemed clinically prone to blistering;&#xD;
&#xD;
          5. Any skin disorder affecting wound healing;&#xD;
&#xD;
          6. Any other condition that in the opinion of the investigator would make a particular&#xD;
             subject unsuitable for this study.&#xD;
&#xD;
          7. Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ulrika Birgersdotter-Green, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Diego</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCSD Sulpizio Cardiovascular Center</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.ziplinemedical.com/</url>
    <description>ZipLine Medical Website</description>
  </link>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <results_first_submitted>February 29, 2016</results_first_submitted>
  <results_first_submitted_qc>May 18, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">May 30, 2016</results_first_posted>
  <last_update_submitted>May 18, 2016</last_update_submitted>
  <last_update_submitted_qc>May 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Diego</investigator_affiliation>
    <investigator_full_name>Ulrika Birgersdotter-Green</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>pacemaker</keyword>
  <keyword>implantable cardioverter defibrillator</keyword>
  <keyword>ICD</keyword>
  <keyword>surgical wound closure</keyword>
  <keyword>sutures</keyword>
  <keyword>Zipline</keyword>
  <keyword>Zips</keyword>
  <keyword>CIED</keyword>
  <keyword>cardiovascular implantable electronic devices</keyword>
  <keyword>arrhythmia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arrhythmias, Cardiac</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Zip Surgical Skin Closure Device</title>
          <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
        </group>
        <group group_id="P2">
          <title>Standard Suture Closure</title>
          <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="21"/>
                <participants group_id="P2" count="19"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Zip Surgical Skin Closure Device</title>
          <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
        </group>
        <group group_id="B2">
          <title>Standard Suture Closure</title>
          <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</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="21"/>
            <count group_id="B2" value="19"/>
            <count group_id="B3" value="40"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71" lower_limit="44" upper_limit="99"/>
                    <measurement group_id="B2" value="70" lower_limit="41" upper_limit="100"/>
                    <measurement group_id="B3" value="70" lower_limit="41" upper_limit="100"/>
                  </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="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </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="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="36"/>
                  </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>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Fitzpatrick Skin Scale</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>1 - Always burns, never tans</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 - Usually burns, tans with difficulty</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 - Somtimes mild burn, gradually tans</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>4 - Rarely burns, tans with ease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>5 - Very rarely burns, tans very easily</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 - Never burns, tans very easily</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Overall Closure Time</title>
        <description>Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zip Surgical Skin Closure Device</title>
            <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
          </group>
          <group group_id="O2">
            <title>Standard Suture Closure</title>
            <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Closure Time</title>
          <description>Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78" spread="30.36"/>
                    <measurement group_id="O2" value="216" spread="93.71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)</title>
        <description>Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).</description>
        <time_frame>3 Months</time_frame>
        <population>Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</population>
        <group_list>
          <group group_id="O1">
            <title>Zip Surgical Skin Closure Device</title>
            <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
          </group>
          <group group_id="O2">
            <title>Standard Suture Closure</title>
            <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)</title>
          <description>Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).</description>
          <population>Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</population>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35.8" spread="40.6"/>
                    <measurement group_id="O2" value="40.6" spread="21.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.655</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgeon Wound Evaluation Scale (WES)</title>
        <description>At 2 weeks post-procedure, the Wound Evaluation Scale was measured. The scale is based from 0 (representing normal skin) to 100 (representing a poor scar).</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zip Surgical Skin Closure Device</title>
            <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
          </group>
          <group group_id="O2">
            <title>Standard Suture Closure</title>
            <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Surgeon Wound Evaluation Scale (WES)</title>
          <description>At 2 weeks post-procedure, the Wound Evaluation Scale was measured. The scale is based from 0 (representing normal skin) to 100 (representing a poor scar).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.82" spread="0.50"/>
                    <measurement group_id="O2" value="5.78" spread="0.55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.811</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgeon Evaluation Based on the Wound Evaluation Scale (WES)</title>
        <description>The surgeon will complete an assessment of the following:&#xD;
Closure Method Satisfaction&#xD;
Scar Satisfaction&#xD;
Wound Healing as judged by Wound Evaluation Scale&#xD;
Scale rated on 1 (least favorable) to 6 (most favorable)&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
        <time_frame>3 Months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zip Surgical Skin Closure Device</title>
            <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
          </group>
          <group group_id="O2">
            <title>Standard Suture Closure</title>
            <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Surgeon Evaluation Based on the Wound Evaluation Scale (WES)</title>
          <description>The surgeon will complete an assessment of the following:&#xD;
Closure Method Satisfaction&#xD;
Scar Satisfaction&#xD;
Wound Healing as judged by Wound Evaluation Scale&#xD;
Scale rated on 1 (least favorable) to 6 (most favorable)&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6" spread="0"/>
                    <measurement group_id="O2" value="6" spread="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surgeon Satisfaction With Scar</title>
        <description>At 3 months post-procedure, the surgeon evaluated their satisfaction on a scale from 1 to 5, 5 being the least favorable.&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zip Surgical Skin Closure Device</title>
            <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
          </group>
          <group group_id="O2">
            <title>Standard Suture Closure</title>
            <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Surgeon Satisfaction With Scar</title>
          <description>At 3 months post-procedure, the surgeon evaluated their satisfaction on a scale from 1 to 5, 5 being the least favorable.&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" spread="0"/>
                    <measurement group_id="O2" value="1.06" spread="0.24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.462</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Comfort</title>
        <description>At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable).</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zip Surgical Skin Closure Device</title>
            <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
          </group>
          <group group_id="O2">
            <title>Standard Suture Closure</title>
            <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Comfort</title>
          <description>At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.77" spread="1.15"/>
                    <measurement group_id="O2" value="1.94" spread="1.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.646</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Satisfaction With Scar</title>
        <description>Patient will complete questionnaires that includes assessments of the following:&#xD;
Pain&#xD;
Closure Method Comfort&#xD;
Closure Method Satisfaction&#xD;
Scar Satisfaction&#xD;
Scar Satisfaction was measured on a scale from 1 (most satisfied) to 5 (least satisfied)&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zip Surgical Skin Closure Device</title>
            <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
          </group>
          <group group_id="O2">
            <title>Standard Suture Closure</title>
            <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction With Scar</title>
          <description>Patient will complete questionnaires that includes assessments of the following:&#xD;
Pain&#xD;
Closure Method Comfort&#xD;
Closure Method Satisfaction&#xD;
Scar Satisfaction&#xD;
Scar Satisfaction was measured on a scale from 1 (most satisfied) to 5 (least satisfied)&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.32" spread="0.48"/>
                    <measurement group_id="O2" value="1.22" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.510</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Rating of Scar</title>
        <description>At 3 months post-procedure, patients were asked to rate their scar. Scale was measured from 0 (best scar) - 10 (worst scar)&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zip Surgical Skin Closure Device</title>
            <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
          </group>
          <group group_id="O2">
            <title>Standard Suture Closure</title>
            <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Rating of Scar</title>
          <description>At 3 months post-procedure, patients were asked to rate their scar. Scale was measured from 0 (best scar) - 10 (worst scar)&#xD;
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.87" spread="0.76"/>
                    <measurement group_id="O2" value="1.04" spread="1.39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.651</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Incision Pain</title>
        <description>At the discharge visit, patients evaluated their level of pain at the incision site based on a scale 1 (least pain) through 10 (worst pain).</description>
        <time_frame>1 day (discharge)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zip Surgical Skin Closure Device</title>
            <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
          </group>
          <group group_id="O2">
            <title>Standard Suture Closure</title>
            <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Incision Pain</title>
          <description>At the discharge visit, patients evaluated their level of pain at the incision site based on a scale 1 (least pain) through 10 (worst pain).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.77" spread="2.48"/>
                    <measurement group_id="O2" value="2.15" spread="1.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.588</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Incision Pain</title>
        <description>At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain).</description>
        <time_frame>2 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zip Surgical Skin Closure Device</title>
            <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
          </group>
          <group group_id="O2">
            <title>Standard Suture Closure</title>
            <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Incision Pain</title>
          <description>At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.64" spread="0.92"/>
                    <measurement group_id="O2" value="0.71" spread="1.41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.858</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Incision Pain</title>
        <description>Incision pain experienced by the patient was evaluated at 3 months post-procedure. This was evaluated on a scale of 0 (least pain) to 10 (worst pain).</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Zip Surgical Skin Closure Device</title>
            <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
          </group>
          <group group_id="O2">
            <title>Standard Suture Closure</title>
            <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Incision Pain</title>
          <description>Incision pain experienced by the patient was evaluated at 3 months post-procedure. This was evaluated on a scale of 0 (least pain) to 10 (worst pain).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="21"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.27" spread="0.41"/>
                    <measurement group_id="O2" value="0.27" spread="0.73"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Zip Surgical Skin Closure Device</title>
          <description>The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.&#xD;
Zip Surgical Skin Closure Device: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.</description>
        </group>
        <group group_id="E2">
          <title>Standard Suture Closure</title>
          <description>The surgeon will perform standard suture closure for the skin layer following CIED procedure.&#xD;
Standard Suture Closure: The surgeon will perform standard suture closure for the skin layer following CIED procedure.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="21"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </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>Ulrika Birgersdotter-Green, MD</name_or_title>
      <organization>UC San Diego School of Medicine</organization>
      <phone>858-657-5310</phone>
      <email>ubgreen@ucsd.edu</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/NCT02213510
org study id: 140718
nct id: NCT02213510
lead sponsor: 
collaborator: 
has dmc: No
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip
      Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for
      surgical incisions or laceration repair. The study will be comparing the Zip Surgical Skin
      Closure to standard sutures in patients undergoing cardiovascular implantable electronic
      device (CIED) procedures on outcomes including closure time, cosmetic appearance of resulting
      scar, and overall cosmetic appearance of scar. The study will be following participants for 3
      months following CIED procedure.
ZipLine Medical, Inc. has developed a novel, non-invasive skin closure device called "Zip
      Surgical Skin Closure" to replace sutures, staples and glue for closure of the skin layer for
      surgical incisions or laceration repair. The device is designed to provide closure speed
      superior to sutures, while resulting in a suture-like cosmetic outcome.The ZIPS study is a
      randomized, clinical trial comparing outcomes of procedures that use the Zip Surgical Skin
      Closure device with the outcomes of procedures that use stitches. The Zip Surgical Skin
      Closure is not an investigational device and is currently used in hospital across the United
      States. The Zip Surgical Skin Closure is a non-invasive (in other words, does not pierce the
      skin or enter into the wound) device to hold skin closed while healing can occur. It adheres
      to the skin close to the incision and uses adjustable straps to hold the incision closed. It
      is typically worn on the skin for 7-14 days and is removed by peeling from the skin. Patients
      will be randomized to either Zip Surgical Skin Closure or sutures, in addition to dissolvable
      sutures for the deeper layers, for surgical procedures for cardiovascular implantable
      electronic devices (CIED) i.e. pacemakers or defibrillators. Both of these closure techniques
      are considered standard of care at this facility and are not themselves experimental.
      However, the goal of this experimental study is to see if there are any significant
      differences between the two closure methods, in a controlled study environment.

      Since the Zip Surgical Skin Closure device is relatively new to the market, there is a
      limited amount of information available describing the experience of patients and doctors
      using the device. In this study, the investigators will be looking to compare the Zip
      Surgical Skin Closure and stitches methods for the time necessary for the surgeon to close
      the incision, cosmetic appearance of the resulting scar, and satisfaction of you and your
      surgeon. The investigators will also be monitoring both study groups for occurrence of any
      adverse (unfavorable) events. Patients will be followed for a total of 3 months for this
      study. All study visits align with standard of care follow up for post-implantation of CIED.
      Non-identifiable pictures will be obtained of the scar during follow up and both patients and
      surgeons will complete questionnaires indicating their experience and satisfaction with the
      either skin closure method.
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: Overall Closure Time
time frame: 2 weeks
description: Duration of time starting when suture needle (control) or Zip device touches the skin until final suture knot is cut or Zip device application is complete (e.g., top liner is removed.)
measure: Wound Healing as Determined by the CVAS (Cosmetic Visual Analogue Scale)
time frame: 3 Months
description: Based on photographs taken of scars taken at 3 months following CIED procedure. The CVAS scale is measured from 0mm (representing best scar) to 100 mm (representing worst scar).
measure: Surgeon Wound Evaluation Scale (WES)
time frame: 2 weeks
description: At 2 weeks post-procedure, the Wound Evaluation Scale was measured. The scale is based from 0 (representing normal skin) to 100 (representing a poor scar).
measure: Surgeon Evaluation Based on the Wound Evaluation Scale (WES)
time frame: 3 Months
description: The surgeon will complete an assessment of the following:
Closure Method Satisfaction
Scar Satisfaction
Wound Healing as judged by Wound Evaluation Scale
Scale rated on 1 (least favorable) to 6 (most favorable)
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
measure: Surgeon Satisfaction With Scar
time frame: 3 months
description: At 3 months post-procedure, the surgeon evaluated their satisfaction on a scale from 1 to 5, 5 being the least favorable.
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
measure: Patient Comfort
time frame: 2 weeks
description: At 2 weeks post-procedure, patient comfort was evaluated with a scale 1 (most favorable) to 5 (least favorable).
measure: Patient Satisfaction With Scar
time frame: 3 months
description: Patient will complete questionnaires that includes assessments of the following:
Pain
Closure Method Comfort
Closure Method Satisfaction
Scar Satisfaction
Scar Satisfaction was measured on a scale from 1 (most satisfied) to 5 (least satisfied)
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
measure: Patient Rating of Scar
time frame: 3 months
description: At 3 months post-procedure, patients were asked to rate their scar. Scale was measured from 0 (best scar) - 10 (worst scar)
Please note that only 18 patients were evaluated (of 19) in the Standard Suture Closure due to one patient withdrawing from the trial.
measure: Patient Incision Pain
time frame: 1 day (discharge)
description: At the discharge visit, patients evaluated their level of pain at the incision site based on a scale 1 (least pain) through 10 (worst pain).
measure: Patient Incision Pain
time frame: 2 weeks
description: At 2 week post-procedure, incision pain was evaluated on a scale 0 to 10 (worst pain).
measure: Patient Incision Pain
time frame: 3 months
description: Incision pain experienced by the patient was evaluated at 3 months post-procedure. This was evaluated on a scale of 0 (least pain) to 10 (worst pain).
arm group label: Zip Surgical Skin Closure device
arm group type: Experimental
description: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
arm group label: Standard Suture Closure
arm group type: Active Comparator
description: The surgeon will perform standard suture closure for the skin layer following CIED procedure.
intervention type: Device
intervention name: Zip Surgical Skin Closure Device
description: The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
arm group label: Zip Surgical Skin Closure device
other name: Wound closure device
intervention type: Device
intervention name: Standard Suture Closure
description: The surgeon will perform standard suture closure for the skin layer following CIED procedure.
arm group label: Standard Suture Closure
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulrika Birgersdotter-Green, MD
role: Principal Investigator
affiliation: University of California, San Diego
facility: 
country: United States
url: http://www.ziplinemedical.com/
description: ZipLine Medical Website
responsible party type: Principal Investigator
investigator affiliation: University of California, San Diego
investigator full name: Ulrika Birgersdotter-Green
investigator title: Clinical Professor
mesh term: Arrhythmias, Cardiac
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 