<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/NCT01716013</url>
  </required_header>
  <id_info>
    <org_study_id>PD-100-002</org_study_id>
    <nct_id>NCT01716013</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of BondEase to Treat Traumatic Lacerations and Surgical Incisions</brief_title>
  <official_title>A Multi-Center, Prospective, Open-label, Randomized Study of the Safety and Efficacy of BondEase™ Topical Skin Adhesive for the Closure of Traumatic Lacerations and Surgical Incisions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OptMed, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OptMed, Inc.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in&#xD;
      terms of cosmesis (appearance) of the repaired wound when these devices are used for closure&#xD;
      of surgical and traumatic wounds .&#xD;
&#xD;
      To demonstrate safety of BondEase™.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a two-phase, multi-center, prospective, randomized, parallel-group study, in which a&#xD;
      total of 153 subjects (102 in the BondEase™ group and 51 in the CWCD group) with traumatic&#xD;
      lacerations and incisions will be enrolled. Overall, eligible subjects will be randomized in&#xD;
      a pre-defined 2:1 ratio to BondEase™ skin adhesive or CWCD.&#xD;
&#xD;
      In Part 1 of the study 30 subjects will be randomized in a 2:1 ratio (BondEase™ : CWCD). This&#xD;
      part of the study is designed to assess the feasibility and validate use of the device.&#xD;
      Pediatric subjects younger than age 18 will not be included in this part of the trial. The&#xD;
      results from these 30 subjects will be compiled and submitted to FDA for review and approval&#xD;
      prior to proceeding with Part 2. Part 2 of the study will only be initiated after FDA&#xD;
      indicates it is acceptable to begin. In Part 2 of the study a total of 123 subjects will be&#xD;
      randomized, of which 82 subjects will be randomized to the BondEase™ group and 41 subjects to&#xD;
      the CWCD group. This will result in 102 subjects in the BondEase™ group and 51 subjects in&#xD;
      the CWCD group across the both parts of the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>100% Wound Apposition at 10 Days</measure>
    <time_frame>10 days</time_frame>
    <description>Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Optimal Cosmetic Outcome at 28 Days (Score of 6)</measure>
    <time_frame>28 days</time_frame>
    <description>Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days.&#xD;
One point was scored for the absence of, and no point was scored for the presence of, any of the following six items:&#xD;
Stepoff of borders (edges not on the same plane)&#xD;
Contour irregularities (wrinkled skin near wound)&#xD;
Margin separation (gap between sides)&#xD;
Edge inversion (wound not properly everted)&#xD;
Excessive distortion (swelling or edema or infection)&#xD;
Poor overall appearance.&#xD;
The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>≥ 50% Wound Apposition at 10 Days</measure>
    <time_frame>10 days</time_frame>
    <description>Incidence of wounds ≥50% apposed (10 ± 3 days)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Wound Dehiscence Requiring Treatment</measure>
    <time_frame>28 Days and 90 days</time_frame>
    <description>Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">162</enrollment>
  <condition>Traumatic Lacerations or Surgical Incisions</condition>
  <arm_group>
    <arm_group_label>BondEase</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Topical Skin Adhesive</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CWCD</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BondEase</intervention_name>
    <description>topical skin adhesive</description>
    <arm_group_label>BondEase</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CWCD</intervention_name>
    <description>traditional closure methods of sutures, staples or adhesive strips</description>
    <arm_group_label>CWCD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male and female subjects at least 1 year of age (for Part 2 only) or at least 18 years&#xD;
             of age (for both Part 1 and Part 2).&#xD;
&#xD;
          2. Has a wound requiring surgical repair, where the use of a tissue adhesive is&#xD;
             appropriate&#xD;
&#xD;
          3. Is in good general health&#xD;
&#xD;
          4. Subject or the guardian understands and is willing to sign informed consent prior to&#xD;
             study entry and agrees to be available for the Day 10, Day 28, and Day 90 (Part&#xD;
             1/pilot phase only) follow-up visits&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Significant or multiple traumas&#xD;
&#xD;
          2. Known peripheral vascular disease&#xD;
&#xD;
          3. Known diabetes mellitus type 1 or type 2&#xD;
&#xD;
          4. Known blood clotting disorder&#xD;
&#xD;
          5. Patient or family history of keloid formation or hypertrophy&#xD;
&#xD;
          6. Known HIV seropositivity or is immunocompromised&#xD;
&#xD;
          7. Been treated with an investigational drug or medical device in the past 30 days&#xD;
&#xD;
          8. A hypersensitivity or contraindication to any of the components of BondEase™&#xD;
&#xD;
          9. Known pre-operative systemic or local infection&#xD;
&#xD;
         10. Any other diseases or conditions which might interfere with the wound healing process&#xD;
&#xD;
         11. The wound to be treated with the test device may not have any of the following&#xD;
             characteristics:&#xD;
&#xD;
               -  A &quot;burst&quot; or stellate laceration&#xD;
&#xD;
               -  Heavily contaminated (Contaminated Wound: wounds that are grossly contaminated&#xD;
                  with foreign material requiring extensive cleansing.&#xD;
&#xD;
               -  Human or animal bite&#xD;
&#xD;
               -  Decubitus etiology&#xD;
&#xD;
               -  Evidence of active infection or gangrene&#xD;
&#xD;
               -  On mucosal surfaces or across mucocutaneous junctions (e.g., oral cavity, lips)&#xD;
&#xD;
               -  On an area which may be regularly exposed to body fluids or with dense natural&#xD;
                  hair, (e.g., scalp)&#xD;
&#xD;
               -  Under tension or over a joint&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Orlando Regional Medical Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>DC Cosmetics</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sadick Research Group</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10075</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest Baptist Health</name>
      <address>
        <city>Wake Forest</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>October 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 24, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <results_first_submitted>September 28, 2016</results_first_submitted>
  <results_first_submitted_qc>September 28, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">November 18, 2016</results_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Surgical Wound</mesh_term>
    <mesh_term>Lacerations</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>BondEase</title>
          <description>Topical Skin Adhesive&#xD;
BondEase: topical skin adhesive</description>
        </group>
        <group group_id="P2">
          <title>CWCD</title>
          <description>Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips&#xD;
CWCD: traditional closure methods of sutures, staples or adhesive strips</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="108"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="105"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Intent-to-treat (ITT) population</population>
      <group_list>
        <group group_id="B1">
          <title>BondEase</title>
          <description>Topical Skin Adhesive&#xD;
BondEase: topical skin adhesive</description>
        </group>
        <group group_id="B2">
          <title>CWCD</title>
          <description>Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips&#xD;
CWCD: traditional closure methods of sutures, staples or adhesive strips</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="105"/>
            <count group_id="B2" value="54"/>
            <count group_id="B3" value="159"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44.4" spread="23.1"/>
                    <measurement group_id="B2" value="47.7" spread="22.3"/>
                    <measurement group_id="B3" value="45.5" spread="22.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Gender</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="49"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="73"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="26"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="133"/>
                  </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>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="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </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="16"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="83"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="129"/>
                  </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="4"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Wound type</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Injury (Laceration)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Surgical incision</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="119"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>100% Wound Apposition at 10 Days</title>
        <description>Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.</description>
        <time_frame>10 days</time_frame>
        <population>Per protocol population (primary analysis dataset)</population>
        <group_list>
          <group group_id="O1">
            <title>BondEase</title>
            <description>Topical Skin Adhesive&#xD;
BondEase: topical skin adhesive</description>
          </group>
          <group group_id="O2">
            <title>CWCD</title>
            <description>Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips&#xD;
CWCD: traditional closure methods of sutures, staples or adhesive strips</description>
          </group>
        </group_list>
        <measure>
          <title>100% Wound Apposition at 10 Days</title>
          <description>Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.</description>
          <population>Per protocol population (primary analysis dataset)</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="96"/>
                <count group_id="O2" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="77.1"/>
                    <measurement group_id="O2" value="80.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Optimal Cosmetic Outcome at 28 Days (Score of 6)</title>
        <description>Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days.&#xD;
One point was scored for the absence of, and no point was scored for the presence of, any of the following six items:&#xD;
Stepoff of borders (edges not on the same plane)&#xD;
Contour irregularities (wrinkled skin near wound)&#xD;
Margin separation (gap between sides)&#xD;
Edge inversion (wound not properly everted)&#xD;
Excessive distortion (swelling or edema or infection)&#xD;
Poor overall appearance.&#xD;
The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal.</description>
        <time_frame>28 days</time_frame>
        <population>Intent-to-treat (ITT) population</population>
        <group_list>
          <group group_id="O1">
            <title>BondEase</title>
            <description>Topical Skin Adhesive&#xD;
BondEase: topical skin adhesive</description>
          </group>
          <group group_id="O2">
            <title>CWCD</title>
            <description>Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips&#xD;
CWCD: traditional closure methods of sutures, staples or adhesive strips</description>
          </group>
        </group_list>
        <measure>
          <title>Optimal Cosmetic Outcome at 28 Days (Score of 6)</title>
          <description>Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days.&#xD;
One point was scored for the absence of, and no point was scored for the presence of, any of the following six items:&#xD;
Stepoff of borders (edges not on the same plane)&#xD;
Contour irregularities (wrinkled skin near wound)&#xD;
Margin separation (gap between sides)&#xD;
Edge inversion (wound not properly everted)&#xD;
Excessive distortion (swelling or edema or infection)&#xD;
Poor overall appearance.&#xD;
The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal.</description>
          <population>Intent-to-treat (ITT) population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.5"/>
                    <measurement group_id="O2" value="64.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>≥ 50% Wound Apposition at 10 Days</title>
        <description>Incidence of wounds ≥50% apposed (10 ± 3 days)</description>
        <time_frame>10 days</time_frame>
        <population>Intent-to-treat (ITT) population</population>
        <group_list>
          <group group_id="O1">
            <title>BondEase</title>
            <description>Topical Skin Adhesive&#xD;
BondEase: topical skin adhesive</description>
          </group>
          <group group_id="O2">
            <title>CWCD</title>
            <description>Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips&#xD;
CWCD: traditional closure methods of sutures, staples or adhesive strips</description>
          </group>
        </group_list>
        <measure>
          <title>≥ 50% Wound Apposition at 10 Days</title>
          <description>Incidence of wounds ≥50% apposed (10 ± 3 days)</description>
          <population>Intent-to-treat (ITT) population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="93.3"/>
                    <measurement group_id="O2" value="96.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Wound Dehiscence Requiring Treatment</title>
        <description>Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up</description>
        <time_frame>28 Days and 90 days</time_frame>
        <population>Intent-to-Treat (ITT) population</population>
        <group_list>
          <group group_id="O1">
            <title>BondEase</title>
            <description>Topical Skin Adhesive&#xD;
BondEase: topical skin adhesive</description>
          </group>
          <group group_id="O2">
            <title>CWCD</title>
            <description>Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips&#xD;
CWCD: traditional closure methods of sutures, staples or adhesive strips</description>
          </group>
        </group_list>
        <measure>
          <title>Wound Dehiscence Requiring Treatment</title>
          <description>Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up</description>
          <population>Intent-to-Treat (ITT) population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="105"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <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_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>BondEase</title>
          <description>Topical Skin Adhesive&#xD;
BondEase: topical skin adhesive</description>
        </group>
        <group group_id="E2">
          <title>CWCD</title>
          <description>Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips&#xD;
CWCD: traditional closure methods of sutures, staples or adhesive strips</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="105"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
              </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="14" subjects_at_risk="105"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Dehiscence with No Need for Retreatment</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="105"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Mild Scar</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="105"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Erythema</sub_title>
                <description>Acute Inflammation at 10 days</description>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="105"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Edema</sub_title>
                <description>Acute Inflammation at 10 days</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="105"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <description>Acute Inflammation at 10 days</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="105"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="54"/>
              </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>Sponsor shall have been furnished copies of any proposed publication or presentation at least thirty (30) days in advance of the submission of such proposed publication or presentation to a journal, editor, or other third party. Sponsor reserves the right to object to the proposed presentation or publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Associate Director of Quality Assurance</name_or_title>
      <organization>OptMed</organization>
      <phone>(908) 720-2372</phone>
      <email>nyajnik@optmed.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01716013
org study id: PD-100-002
nct id: NCT01716013
lead sponsor: 
has dmc: Yes
To demonstrate that BondEase™ and conventional wound closure devices (CWCD) are the same in
      terms of cosmesis (appearance) of the repaired wound when these devices are used for closure
      of surgical and traumatic wounds .

      To demonstrate safety of BondEase™.
This is a two-phase, multi-center, prospective, randomized, parallel-group study, in which a
      total of 153 subjects (102 in the BondEase™ group and 51 in the CWCD group) with traumatic
      lacerations and incisions will be enrolled. Overall, eligible subjects will be randomized in
      a pre-defined 2:1 ratio to BondEase™ skin adhesive or CWCD.

      In Part 1 of the study 30 subjects will be randomized in a 2:1 ratio (BondEase™ : CWCD). This
      part of the study is designed to assess the feasibility and validate use of the device.
      Pediatric subjects younger than age 18 will not be included in this part of the trial. The
      results from these 30 subjects will be compiled and submitted to FDA for review and approval
      prior to proceeding with Part 2. Part 2 of the study will only be initiated after FDA
      indicates it is acceptable to begin. In Part 2 of the study a total of 123 subjects will be
      randomized, of which 82 subjects will be randomized to the BondEase™ group and 41 subjects to
      the CWCD group. This will result in 102 subjects in the BondEase™ group and 51 subjects in
      the CWCD group across the both parts of the trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: 100% Wound Apposition at 10 Days
time frame: 10 days
description: Percentage of subjects in whom 100% wound edge apposition is achieved at 10 days (±3 days) post-procedure.
measure: Optimal Cosmetic Outcome at 28 Days (Score of 6)
time frame: 28 days
description: Incidence of wounds with an optimal cosmetic outcome (score of 6) at 28 days.
One point was scored for the absence of, and no point was scored for the presence of, any of the following six items:
Stepoff of borders (edges not on the same plane)
Contour irregularities (wrinkled skin near wound)
Margin separation (gap between sides)
Edge inversion (wound not properly everted)
Excessive distortion (swelling or edema or infection)
Poor overall appearance.
The overall cosmesis score was determined by adding the scores of each individual item. An overall score of six was considered an optimal score outcome. Any score below six was considered suboptimal.
measure: ≥ 50% Wound Apposition at 10 Days
time frame: 10 days
description: Incidence of wounds ≥50% apposed (10 ± 3 days)
measure: Wound Dehiscence Requiring Treatment
time frame: 28 Days and 90 days
description: Wound dehiscence requiring treatment; i.e., need for supplemental closure due to dehiscence at any time, from closure through follow-up
arm group label: BondEase
arm group type: Experimental
description: Topical Skin Adhesive
arm group label: CWCD
arm group type: Active Comparator
description: Conventional Wound Closure Devices (CWCD) including: sutures, staples, or adhesive strips
intervention type: Device
intervention name: BondEase
description: topical skin adhesive
arm group label: BondEase
intervention type: Procedure
intervention name: CWCD
description: traditional closure methods of sutures, staples or adhesive strips
arm group label: CWCD
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Surgical Wound
mesh term: Lacerations
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 