<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/NCT02212977</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00056064</org_study_id>
    <nct_id>NCT02212977</nct_id>
  </id_info>
  <brief_title>Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions</brief_title>
  <official_title>Comparison of Topical Skin Adhesive to Subcuticular Suture Closure of Implantable Port Incisions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with&#xD;
      stitches in Port a Cath patients, who, as a population, are at increased risk for&#xD;
      complications. All adult patients who present for initial Port a Cath placement during the&#xD;
      recruitment period will be eligible to participate in the study. Subjects will be randomized&#xD;
      to either skin incision closure with standard stitches or closure with skin glue. Time to&#xD;
      complete skin closure and costs of closure will be compared. Patients will be evaluated&#xD;
      approximately one month and three months from the procedure to assess for complications of&#xD;
      wound breakdown or infection, as well as for the appearance of the Port a Cath incision.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">September 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Complication of Wound Dehiscence</measure>
    <time_frame>3 months</time_frame>
    <description>To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants With Complication of Infection</measure>
    <time_frame>3 months</time_frame>
    <description>To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Healing-incision Cosmesis Score by Visual Analogue Scale</measure>
    <time_frame>3 months</time_frame>
    <description>To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Closure Time</measure>
    <time_frame>Baseline</time_frame>
    <description>To compare closure time and associated costs between these two methods of skin closure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Closure Materials Cost</measure>
    <time_frame>Baseline</time_frame>
    <description>Per unit cost for suture and octylcyanoacrylate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">109</enrollment>
  <condition>Port-A-Cath Placement</condition>
  <condition>Octylcyanoacrylate</condition>
  <arm_group>
    <arm_group_label>Suture</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Octylcyanoacrylate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Skin incision closure with topic skin adhesive Octylcyanoacrylate</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Octylcyanoacrylate</intervention_name>
    <description>Skin incision closure with topic skin adhesive Octylcyanoacrylate</description>
    <arm_group_label>Octylcyanoacrylate</arm_group_label>
    <other_name>Octyl 2-cyanoacrylate</other_name>
    <other_name>2-octylcyanoacrylate</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Suture</intervention_name>
    <description>Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture</description>
    <arm_group_label>Suture</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients (≥18 years) who present for initial implantable port placement&#xD;
             during the recruitment period will be eligible to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who cannot provide informed consent for the procedure will be excluded from&#xD;
             the study.&#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>Charles Kim, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>August 7, 2014</study_first_submitted>
  <study_first_submitted_qc>August 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 11, 2014</study_first_posted>
  <results_first_submitted>June 20, 2016</results_first_submitted>
  <results_first_submitted_qc>October 14, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 18, 2016</results_first_posted>
  <last_update_submitted>October 14, 2016</last_update_submitted>
  <last_update_submitted_qc>October 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Port Catheter</keyword>
  <keyword>Octyl 2-cyanoacrylate</keyword>
  <keyword>2-octylcyanoacrylate</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Suture</title>
          <description>Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture&#xD;
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture</description>
        </group>
        <group group_id="P2">
          <title>Octylcyanoacrylate</title>
          <description>Skin incision closure with topic skin adhesive Octylcyanoacrylate&#xD;
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="48"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="6"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Suture</title>
          <description>Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture&#xD;
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture</description>
        </group>
        <group group_id="B2">
          <title>Octylcyanoacrylate</title>
          <description>Skin incision closure with topic skin adhesive Octylcyanoacrylate&#xD;
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate</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="55"/>
            <count group_id="B2" value="54"/>
            <count group_id="B3" value="109"/>
          </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="59" spread="7.5"/>
                    <measurement group_id="B2" value="58.3" spread="7.6"/>
                    <measurement group_id="B3" value="58.7" spread="7.6"/>
                  </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="46"/>
                    <measurement group_id="B2" value="35"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Complication of Wound Dehiscence</title>
        <description>To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Suture</title>
            <description>Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture&#xD;
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture</description>
          </group>
          <group group_id="O2">
            <title>Octylcyanoacrylate</title>
            <description>Skin incision closure with topic skin adhesive Octylcyanoacrylate&#xD;
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complication of Wound Dehiscence</title>
          <description>To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="48"/>
              </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>
        <type>Primary</type>
        <title>Number of Participants With Complication of Infection</title>
        <description>To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.</description>
        <time_frame>3 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Suture</title>
            <description>Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture&#xD;
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture</description>
          </group>
          <group group_id="O2">
            <title>Octylcyanoacrylate</title>
            <description>Skin incision closure with topic skin adhesive Octylcyanoacrylate&#xD;
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Complication of Infection</title>
          <description>To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="48"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Healing-incision Cosmesis Score by Visual Analogue Scale</title>
        <description>To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome.</description>
        <time_frame>3 months</time_frame>
        <population>Only participants who completed the Healing-incision cosmesis score by Visual Analogue Scale were included in the analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Suture</title>
            <description>Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture&#xD;
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture</description>
          </group>
          <group group_id="O2">
            <title>Octylcyanoacrylate</title>
            <description>Skin incision closure with topic skin adhesive Octylcyanoacrylate&#xD;
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate</description>
          </group>
        </group_list>
        <measure>
          <title>Healing-incision Cosmesis Score by Visual Analogue Scale</title>
          <description>To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome.</description>
          <population>Only participants who completed the Healing-incision cosmesis score by Visual Analogue Scale were included in the analysis.</population>
          <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="45"/>
                <count group_id="O2" value="41"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.46" spread="2.4"/>
                    <measurement group_id="O2" value="4.4" spread="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Closure Time</title>
        <description>To compare closure time and associated costs between these two methods of skin closure.</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Suture</title>
            <description>Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture&#xD;
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture</description>
          </group>
          <group group_id="O2">
            <title>Octylcyanoacrylate</title>
            <description>Skin incision closure with topic skin adhesive Octylcyanoacrylate&#xD;
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate</description>
          </group>
        </group_list>
        <measure>
          <title>Closure Time</title>
          <description>To compare closure time and associated costs between these two methods of skin closure.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.6" spread="3.7"/>
                    <measurement group_id="O2" value="1.6" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Closure Materials Cost</title>
        <description>Per unit cost for suture and octylcyanoacrylate</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Suture</title>
            <description>Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture&#xD;
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture</description>
          </group>
          <group group_id="O2">
            <title>Octylcyanoacrylate</title>
            <description>Skin incision closure with topic skin adhesive Octylcyanoacrylate&#xD;
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate</description>
          </group>
        </group_list>
        <measure>
          <title>Closure Materials Cost</title>
          <description>Per unit cost for suture and octylcyanoacrylate</description>
          <units>dollars</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="55"/>
                <count group_id="O2" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.54"/>
                    <measurement group_id="O2" value="25.92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Suture</title>
          <description>Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture&#xD;
Suture: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture</description>
        </group>
        <group group_id="E2">
          <title>Octylcyanoacrylate</title>
          <description>Skin incision closure with topic skin adhesive Octylcyanoacrylate&#xD;
Octylcyanoacrylate: Skin incision closure with topic skin adhesive Octylcyanoacrylate</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="55"/>
                <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="0" subjects_at_risk="55"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Small sample size, underpowered to demonstrate small differences in rates of dehiscence or infection.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Charles Kim</name_or_title>
      <organization>Duke University Medical Center</organization>
      <phone>9196847424</phone>
      <email>charles.kim@duke.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/NCT02212977
org study id: Pro00056064
nct id: NCT02212977
lead sponsor: 
has dmc: No
Hypothesis is that incision closure with octylcyanoacrylate is inferior to closure with
      stitches in Port a Cath patients, who, as a population, are at increased risk for
      complications. All adult patients who present for initial Port a Cath placement during the
      recruitment period will be eligible to participate in the study. Subjects will be randomized
      to either skin incision closure with standard stitches or closure with skin glue. Time to
      complete skin closure and costs of closure will be compared. Patients will be evaluated
      approximately one month and three months from the procedure to assess for complications of
      wound breakdown or infection, as well as for the appearance of the Port a Cath incision.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Number of Participants With Complication of Wound Dehiscence
time frame: 3 months
description: To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.
measure: Number of Participants With Complication of Infection
time frame: 3 months
description: To compare complication rates, including wound dehiscence and infection rates between implantable port incisions closed with topical skin adhesive versus absorbable subcuticular sutures.
measure: Healing-incision Cosmesis Score by Visual Analogue Scale
time frame: 3 months
description: To compare resultant cosmesis with topic skin adhesive closure versus suture closure. Scale is 1-10 with 1 as the best possible outcome and 10 is the worst possible outcome.
measure: Closure Time
time frame: Baseline
description: To compare closure time and associated costs between these two methods of skin closure.
measure: Closure Materials Cost
time frame: Baseline
description: Per unit cost for suture and octylcyanoacrylate
arm group label: Suture
arm group type: Active Comparator
description: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
arm group label: Octylcyanoacrylate
arm group type: Experimental
description: Skin incision closure with topic skin adhesive Octylcyanoacrylate
intervention type: Device
intervention name: Octylcyanoacrylate
description: Skin incision closure with topic skin adhesive Octylcyanoacrylate
arm group label: Octylcyanoacrylate
other name: Octyl 2-cyanoacrylate
other name: 2-octylcyanoacrylate
intervention type: Procedure
intervention name: Suture
description: Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
arm group label: Suture
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Charles Kim, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Small sample size, underpowered to demonstrate small differences in rates of dehiscence or infection.
point of contact: 