<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/NCT03280628</url>
  </required_header>
  <id_info>
    <org_study_id>171108</org_study_id>
    <nct_id>NCT03280628</nct_id>
  </id_info>
  <brief_title>Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using Skin Glue, Medical Tape Versus Stitches</brief_title>
  <official_title>A Randomized Controlled Trial Comparing Cosmetic Outcomes of Pediatric Laceration Closure Using a Tissue Adhesive (Dermabond™) Versus Adhesive Strips (Steri-Strips™) Versus Absorbable Sutures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are several methods of closing a skin cut: stitches, skin glue, and medical tape.&#xD;
      Stitches have been used for a long time to close skin cuts. Skin glue (invented in the 1970s)&#xD;
      and medical tape (invented in the 1960s) are two newer methods to close skin cuts. The&#xD;
      purpose of this study is to find out which method (stitches, skin glue, or medical tape) of&#xD;
      closing skin cuts results in the least amount of scarring. Other things the investigators&#xD;
      will be looking at are which method is the cheapest, which causes the least pain, which&#xD;
      requires the least amount of sedation, and which method patients and parents like the best.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      When a child comes in to the Emergency Room with a skin cut, if the child and their parents&#xD;
      consent to being in the study, they will be randomly assigned to one of three groups:&#xD;
      stitches, skin glue, or medical tape. There will be about 30 kids in each group, and thus a&#xD;
      goal of 90 kids total in the study.&#xD;
&#xD;
      In the Emergency Room, a lidocaine ointment will be placed on the child's cut to decrease&#xD;
      pain. The cut will be cleaned out with sterile saline. Then, depending on which method is&#xD;
      used, the cut will be closed with either stitches, skin glue, or medical tape by their&#xD;
      doctor. The participants will be asked to answer a short questionnaire. Finally, they will be&#xD;
      given discharge instructions and sent home. At 3 months, the investigators will call parents&#xD;
      for a quick questionnaire over the phone and parents will be asked to take a picture of the&#xD;
      patient's scar and send it to the study staff.&#xD;
&#xD;
      Once all 90 pictures have been collected, two Plastic Surgeons will be asked to rate the&#xD;
      scars in terms of how they look. The Plastic Surgeons will not know which method was used to&#xD;
      close which cut. Once all of the scars have been rated, the averages of scars will be&#xD;
      compared for each closure method. The investigators will also look at how much each method&#xD;
      cost, how much extra pain medications or sedation each group used, and which method was liked&#xD;
      best.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The COVID-19 pandemic made prospective enrollment no longer possible&#xD;
  </why_stopped>
  <start_date type="Actual">September 23, 2017</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">February 1, 2021</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>
    <masking_description>The Plastic Surgeons who rate all scars at the end of the study are blinded to the closure method.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Cosmetic Outcome of Scar at 3 Months</measure>
    <time_frame>3 months</time_frame>
    <description>Two blinded Plastic Surgeons will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;worst scar&quot; and a score of 100 corresponding to &quot;best scar&quot;</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Experienced by Patient as Reported by Parent</measure>
    <time_frame>Baseline</time_frame>
    <description>Parents will each be asked to score how much pain they felt the patient experienced using a 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;No pain&quot; and a score of 100 corresponding to &quot;Terrible pain.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction With Time in the Emergency Department</measure>
    <time_frame>Baseline to wound closure, up to 30 minutes</time_frame>
    <description>Parents will report their satisfaction with Emergency Department length of stay using a 100-point visual analog scale with &quot;100&quot; meaning completely satisfied and &quot;0&quot; meaning not at all satisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Likelihood That Parent Would Recommend Laceration Closure Method</measure>
    <time_frame>Post-wound closure, approximately 30 minutes</time_frame>
    <description>Parents will be asked to rate how likely they would be to recommend the closure method used for their child using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;Extremely unlikely&quot; and a score of 100 corresponding to &quot;Extremely likely&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Complications of the Wound Site</measure>
    <time_frame>3 months</time_frame>
    <description>Parents will be asked by phone at 3 months if there were any complications with their child's cut (infection, opening of the wound, etc.). Investigators will count the number of complications reported.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental Reported Satisfaction With the Cosmetic Appearance of the Scar</measure>
    <time_frame>3 months</time_frame>
    <description>Parents will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;worst scar&quot; and a score of 100 corresponding to &quot;best scar&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of Train Tracks at the Scar Site</measure>
    <time_frame>3 months</time_frame>
    <description>Plastic Surgeons will record if a scar appears to have &quot;train tracks&quot; (or small dots on either side of a scar, all along the scar, usually caused by stitches) as they are rating each photo of the scar at 3 months post-closure. Surgeons will answer &quot;yes&quot; or &quot;no&quot;.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Laceration</condition>
  <arm_group>
    <arm_group_label>Absorbable Sutures</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Steri-Strips</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will have their laceration closed with a special medical tape called &quot;Steri-Strips.&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dermabond</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will have their laceration closed with a special skin glue called &quot;Dermabond&quot;</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Absorbable Sutures</intervention_name>
    <description>The patient's doctor will close the patient's laceration with absorbable sutures.</description>
    <arm_group_label>Absorbable Sutures</arm_group_label>
    <other_name>Stitches</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Steri-Strips</intervention_name>
    <description>The patient's doctor will close the patient's laceration with Steri-Strips.</description>
    <arm_group_label>Steri-Strips</arm_group_label>
    <other_name>Medical tape</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Dermabond</intervention_name>
    <description>The patient's doctor will close the patient's laceration with Dermabond.</description>
    <arm_group_label>Dermabond</arm_group_label>
    <other_name>Skin glue</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical complaint of laceration&#xD;
&#xD;
          -  Single, linear laceration&#xD;
&#xD;
          -  Laceration less than 5 cm in length and 0.5 cm in width&#xD;
&#xD;
          -  Laceration less than 12 hours old&#xD;
&#xD;
          -  Laceration minimally contaminated (no visible dirt in wound)&#xD;
&#xD;
          -  Parents and child speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant medical history that may impact wound healing (hematologic or oncologic&#xD;
             diagnosis requiring chemotherapy, ichthyosis, epidermolysis bullosa, etc.)&#xD;
&#xD;
          -  Use of oral steroids (more than 5 days in the past month)&#xD;
&#xD;
          -  History of keloid formation&#xD;
&#xD;
          -  Allergy to skin glue, medical tape, or topical anesthetics&#xD;
&#xD;
          -  Lacerations requiring deep sutures&#xD;
&#xD;
          -  Lacerations caused by animal bites or scratches&#xD;
&#xD;
          -  Lacerations located on the scalp, eyebrow, eyelid, lip, mucosa, joint or nail bed&#xD;
&#xD;
          -  No access to photographic capabilities (camera or smartphone) and/or e-mail, OR unable&#xD;
             to return to the Vanderbilt Children's Hospital Emergency Room to have a picture taken&#xD;
             at 3 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Holly R Hanson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt Children's Hospital</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>September 10, 2017</study_first_submitted>
  <study_first_submitted_qc>September 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 12, 2017</study_first_posted>
  <results_first_submitted>March 30, 2022</results_first_submitted>
  <results_first_submitted_qc>September 7, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">July 17, 2023</results_first_posted>
  <last_update_submitted>September 7, 2022</last_update_submitted>
  <last_update_submitted_qc>September 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Holly Hanson</investigator_full_name>
    <investigator_title>Asst Professor of Clinical Pediatrics</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lacerations</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 10, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03280628/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT03280628/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Absorbable Sutures</title>
          <description>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.&#xD;
Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures.</description>
        </group>
        <group group_id="P2">
          <title>Steri-Strips</title>
          <description>Patients will have their laceration closed with a special medical tape called &quot;Steri-Strips.&quot;&#xD;
Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips.</description>
        </group>
        <group group_id="P3">
          <title>Dermabond</title>
          <description>Patients will have their laceration closed with a special skin glue called &quot;Dermabond&quot;&#xD;
Dermabond: The patient's doctor will close the patient's laceration with Dermabond.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="11"/>
                <participants group_id="P3" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Absorbable Sutures</title>
          <description>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.&#xD;
Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures.</description>
        </group>
        <group group_id="B2">
          <title>Steri-Strips</title>
          <description>Patients will have their laceration closed with a special medical tape called &quot;Steri-Strips.&quot;&#xD;
Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips.</description>
        </group>
        <group group_id="B3">
          <title>Dermabond</title>
          <description>Patients will have their laceration closed with a special skin glue called &quot;Dermabond&quot;&#xD;
Dermabond: The patient's doctor will close the patient's laceration with Dermabond.</description>
        </group>
        <group group_id="B4">
          <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="20"/>
            <count group_id="B2" value="17"/>
            <count group_id="B3" value="18"/>
            <count group_id="B4" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3.50" lower_limit="2.75" upper_limit="5.00"/>
                    <measurement group_id="B2" value="3.00" lower_limit="2.00" upper_limit="5.00"/>
                    <measurement group_id="B3" value="4.00" lower_limit="3.00" upper_limit="5.00"/>
                    <measurement group_id="B4" value="3.00" lower_limit="2.75" upper_limit="5.00"/>
                  </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="3"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="43"/>
                  </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="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="50"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Laceration Length (cm)</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.50" lower_limit="1.19" upper_limit="2.00"/>
                    <measurement group_id="B2" value="1.00" lower_limit="1.00" upper_limit="1.50"/>
                    <measurement group_id="B3" value="1.50" lower_limit="1.00" upper_limit="2.00"/>
                    <measurement group_id="B4" value="1.50" lower_limit="1.00" upper_limit="1.94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Laceration Width (cm)</title>
          <units>cm</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.50" lower_limit="0.30" upper_limit="0.50"/>
                    <measurement group_id="B2" value="0.50" lower_limit="0.30" upper_limit="0.50"/>
                    <measurement group_id="B3" value="0.50" lower_limit="0.50" upper_limit="0.50"/>
                    <measurement group_id="B4" value="0.50" lower_limit="0.30" upper_limit="0.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Training Level of Proceduralist</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Resident</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="10"/>
                    <measurement group_id="B4" value="28"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Fellow</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Nurse Practitioner</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Attending</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cosmetic Outcome of Scar at 3 Months</title>
        <description>Two blinded Plastic Surgeons will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;worst scar&quot; and a score of 100 corresponding to &quot;best scar&quot;</description>
        <time_frame>3 months</time_frame>
        <population>55 subjects were enrolled in the Emergency Department but only 30 subjects sent 3 month follow-up photos of their child's scar thus only 30 scars were reviewed by the plastic surgeons.</population>
        <group_list>
          <group group_id="O1">
            <title>Absorbable Sutures</title>
            <description>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.&#xD;
Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures.</description>
          </group>
          <group group_id="O2">
            <title>Steri-Strips</title>
            <description>Patients will have their laceration closed with a special medical tape called &quot;Steri-Strips.&quot;&#xD;
Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips.</description>
          </group>
          <group group_id="O3">
            <title>Dermabond</title>
            <description>Patients will have their laceration closed with a special skin glue called &quot;Dermabond&quot;&#xD;
Dermabond: The patient's doctor will close the patient's laceration with Dermabond.</description>
          </group>
        </group_list>
        <measure>
          <title>Cosmetic Outcome of Scar at 3 Months</title>
          <description>Two blinded Plastic Surgeons will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;worst scar&quot; and a score of 100 corresponding to &quot;best scar&quot;</description>
          <population>55 subjects were enrolled in the Emergency Department but only 30 subjects sent 3 month follow-up photos of their child's scar thus only 30 scars were reviewed by the plastic surgeons.</population>
          <units>units on a visual analog scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64.00" lower_limit="51.00" upper_limit="76.00"/>
                    <measurement group_id="O2" value="54.00" lower_limit="35.50" upper_limit="66.75"/>
                    <measurement group_id="O3" value="48.50" lower_limit="29.50" upper_limit="78.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Experienced by Patient as Reported by Parent</title>
        <description>Parents will each be asked to score how much pain they felt the patient experienced using a 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;No pain&quot; and a score of 100 corresponding to &quot;Terrible pain.&quot;</description>
        <time_frame>Baseline</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Absorbable Sutures</title>
            <description>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.&#xD;
Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures.</description>
          </group>
          <group group_id="O2">
            <title>Steri-Strips</title>
            <description>Patients will have their laceration closed with a special medical tape called &quot;Steri-Strips.&quot;&#xD;
Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips.</description>
          </group>
          <group group_id="O3">
            <title>Dermabond</title>
            <description>Patients will have their laceration closed with a special skin glue called &quot;Dermabond&quot;&#xD;
Dermabond: The patient's doctor will close the patient's laceration with Dermabond.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Experienced by Patient as Reported by Parent</title>
          <description>Parents will each be asked to score how much pain they felt the patient experienced using a 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;No pain&quot; and a score of 100 corresponding to &quot;Terrible pain.&quot;</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17.00" lower_limit="1.50" upper_limit="51.50"/>
                    <measurement group_id="O2" value="22.00" lower_limit="9.00" upper_limit="28.00"/>
                    <measurement group_id="O3" value="11.00" lower_limit="3.00" upper_limit="24.50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Satisfaction With Time in the Emergency Department</title>
        <description>Parents will report their satisfaction with Emergency Department length of stay using a 100-point visual analog scale with &quot;100&quot; meaning completely satisfied and &quot;0&quot; meaning not at all satisfied</description>
        <time_frame>Baseline to wound closure, up to 30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Absorbable Sutures</title>
            <description>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.&#xD;
Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures.</description>
          </group>
          <group group_id="O2">
            <title>Steri-Strips</title>
            <description>Patients will have their laceration closed with a special medical tape called &quot;Steri-Strips.&quot;&#xD;
Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips.</description>
          </group>
          <group group_id="O3">
            <title>Dermabond</title>
            <description>Patients will have their laceration closed with a special skin glue called &quot;Dermabond&quot;&#xD;
Dermabond: The patient's doctor will close the patient's laceration with Dermabond.</description>
          </group>
        </group_list>
        <measure>
          <title>Satisfaction With Time in the Emergency Department</title>
          <description>Parents will report their satisfaction with Emergency Department length of stay using a 100-point visual analog scale with &quot;100&quot; meaning completely satisfied and &quot;0&quot; meaning not at all satisfied</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="89.50" lower_limit="45.25" upper_limit="98.50"/>
                    <measurement group_id="O2" value="92.00" lower_limit="83.00" upper_limit="100.00"/>
                    <measurement group_id="O3" value="94.00" lower_limit="71.25" upper_limit="100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Likelihood That Parent Would Recommend Laceration Closure Method</title>
        <description>Parents will be asked to rate how likely they would be to recommend the closure method used for their child using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;Extremely unlikely&quot; and a score of 100 corresponding to &quot;Extremely likely&quot;</description>
        <time_frame>Post-wound closure, approximately 30 minutes</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Absorbable Sutures</title>
            <description>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.&#xD;
Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures.</description>
          </group>
          <group group_id="O2">
            <title>Steri-Strips</title>
            <description>Patients will have their laceration closed with a special medical tape called &quot;Steri-Strips.&quot;&#xD;
Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips.</description>
          </group>
          <group group_id="O3">
            <title>Dermabond</title>
            <description>Patients will have their laceration closed with a special skin glue called &quot;Dermabond&quot;&#xD;
Dermabond: The patient's doctor will close the patient's laceration with Dermabond.</description>
          </group>
        </group_list>
        <measure>
          <title>Likelihood That Parent Would Recommend Laceration Closure Method</title>
          <description>Parents will be asked to rate how likely they would be to recommend the closure method used for their child using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;Extremely unlikely&quot; and a score of 100 corresponding to &quot;Extremely likely&quot;</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.50" lower_limit="88.00" upper_limit="100.00"/>
                    <measurement group_id="O2" value="99.00" lower_limit="95.00" upper_limit="100.00"/>
                    <measurement group_id="O3" value="99.50" lower_limit="94.50" upper_limit="100.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Complications of the Wound Site</title>
        <description>Parents will be asked by phone at 3 months if there were any complications with their child's cut (infection, opening of the wound, etc.). Investigators will count the number of complications reported.</description>
        <time_frame>3 months</time_frame>
        <population>55 subject were enrolled but only 30 completed 3 month follow-up. This outcome measure was collected at 3 months.</population>
        <group_list>
          <group group_id="O1">
            <title>Absorbable Sutures</title>
            <description>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.&#xD;
Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures.</description>
          </group>
          <group group_id="O2">
            <title>Steri-Strips</title>
            <description>Patients will have their laceration closed with a special medical tape called &quot;Steri-Strips.&quot;&#xD;
Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips.</description>
          </group>
          <group group_id="O3">
            <title>Dermabond</title>
            <description>Patients will have their laceration closed with a special skin glue called &quot;Dermabond&quot;&#xD;
Dermabond: The patient's doctor will close the patient's laceration with Dermabond.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Complications of the Wound Site</title>
          <description>Parents will be asked by phone at 3 months if there were any complications with their child's cut (infection, opening of the wound, etc.). Investigators will count the number of complications reported.</description>
          <population>55 subject were enrolled but only 30 completed 3 month follow-up. This outcome measure was collected at 3 months.</population>
          <units>complications</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="7"/>
              </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 group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Parental Reported Satisfaction With the Cosmetic Appearance of the Scar</title>
        <description>Parents will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;worst scar&quot; and a score of 100 corresponding to &quot;best scar&quot;.</description>
        <time_frame>3 months</time_frame>
        <population>Only 30 parents/subjects provided 3 month follow-up photos of their scar</population>
        <group_list>
          <group group_id="O1">
            <title>Absorbable Sutures</title>
            <description>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.&#xD;
Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures.</description>
          </group>
          <group group_id="O2">
            <title>Steri-Strips</title>
            <description>Patients will have their laceration closed with a special medical tape called &quot;Steri-Strips.&quot;&#xD;
Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips.</description>
          </group>
          <group group_id="O3">
            <title>Dermabond</title>
            <description>Patients will have their laceration closed with a special skin glue called &quot;Dermabond&quot;&#xD;
Dermabond: The patient's doctor will close the patient's laceration with Dermabond.</description>
          </group>
        </group_list>
        <measure>
          <title>Parental Reported Satisfaction With the Cosmetic Appearance of the Scar</title>
          <description>Parents will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to &quot;worst scar&quot; and a score of 100 corresponding to &quot;best scar&quot;.</description>
          <population>Only 30 parents/subjects provided 3 month follow-up photos of their scar</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.50" lower_limit="59.75" upper_limit="76.75"/>
                    <measurement group_id="O2" value="67.00" lower_limit="55.00" upper_limit="78.00"/>
                    <measurement group_id="O3" value="85.00" lower_limit="73.00" upper_limit="90.00"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Presence of Train Tracks at the Scar Site</title>
        <description>Plastic Surgeons will record if a scar appears to have &quot;train tracks&quot; (or small dots on either side of a scar, all along the scar, usually caused by stitches) as they are rating each photo of the scar at 3 months post-closure. Surgeons will answer &quot;yes&quot; or &quot;no&quot;.</description>
        <time_frame>3 months</time_frame>
        <population>55 subjects were enrolled but only 30 subjects submitted scar photos 3 months after closure.</population>
        <group_list>
          <group group_id="O1">
            <title>Absorbable Sutures</title>
            <description>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.&#xD;
Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures.</description>
          </group>
          <group group_id="O2">
            <title>Steri-Strips</title>
            <description>Patients will have their laceration closed with a special medical tape called &quot;Steri-Strips.&quot;&#xD;
Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips.</description>
          </group>
          <group group_id="O3">
            <title>Dermabond</title>
            <description>Patients will have their laceration closed with a special skin glue called &quot;Dermabond&quot;&#xD;
Dermabond: The patient's doctor will close the patient's laceration with Dermabond.</description>
          </group>
        </group_list>
        <measure>
          <title>Presence of Train Tracks at the Scar Site</title>
          <description>Plastic Surgeons will record if a scar appears to have &quot;train tracks&quot; (or small dots on either side of a scar, all along the scar, usually caused by stitches) as they are rating each photo of the scar at 3 months post-closure. Surgeons will answer &quot;yes&quot; or &quot;no&quot;.</description>
          <population>55 subjects were enrolled but only 30 subjects submitted scar photos 3 months after closure.</population>
          <units>scars with train tracks</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="12"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 3 months post-procedure.</time_frame>
      <desc>No difference in definition for adverse event and serious adverse event.</desc>
      <group_list>
        <group group_id="E1">
          <title>Absorbable Sutures</title>
          <description>Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.&#xD;
Absorbable Sutures: The patient's doctor will close the patient's laceration with absorbable sutures.</description>
        </group>
        <group group_id="E2">
          <title>Steri-Strips</title>
          <description>Patients will have their laceration closed with a special medical tape called &quot;Steri-Strips.&quot;&#xD;
Steri-Strips: The patient's doctor will close the patient's laceration with Steri-Strips.</description>
        </group>
        <group group_id="E3">
          <title>Dermabond</title>
          <description>Patients will have their laceration closed with a special skin glue called &quot;Dermabond&quot;&#xD;
Dermabond: The patient's doctor will close the patient's laceration with Dermabond.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </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="20"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="17"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="18"/>
              </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>
    <limitations_and_caveats>Early termination of the study due to limitation regarding the COVID-19 pandemic and prospective enrollment of pediatric patients in the Emergency Department. There were also only 55% of subjects who performed 3 month follow-up thus our primary outcome can only be measured on these subjects.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Holly Hanson</name_or_title>
      <organization>Vanderbilt University Medical Center</organization>
      <phone>615-936-7317</phone>
      <email>holly.r.hanson@vumc.org</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03280628
org study id: 171108
nct id: NCT03280628
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
There are several methods of closing a skin cut: stitches, skin glue, and medical tape.
      Stitches have been used for a long time to close skin cuts. Skin glue (invented in the 1970s)
      and medical tape (invented in the 1960s) are two newer methods to close skin cuts. The
      purpose of this study is to find out which method (stitches, skin glue, or medical tape) of
      closing skin cuts results in the least amount of scarring. Other things the investigators
      will be looking at are which method is the cheapest, which causes the least pain, which
      requires the least amount of sedation, and which method patients and parents like the best.
When a child comes in to the Emergency Room with a skin cut, if the child and their parents
      consent to being in the study, they will be randomly assigned to one of three groups:
      stitches, skin glue, or medical tape. There will be about 30 kids in each group, and thus a
      goal of 90 kids total in the study.

      In the Emergency Room, a lidocaine ointment will be placed on the child's cut to decrease
      pain. The cut will be cleaned out with sterile saline. Then, depending on which method is
      used, the cut will be closed with either stitches, skin glue, or medical tape by their
      doctor. The participants will be asked to answer a short questionnaire. Finally, they will be
      given discharge instructions and sent home. At 3 months, the investigators will call parents
      for a quick questionnaire over the phone and parents will be asked to take a picture of the
      patient's scar and send it to the study staff.

      Once all 90 pictures have been collected, two Plastic Surgeons will be asked to rate the
      scars in terms of how they look. The Plastic Surgeons will not know which method was used to
      close which cut. Once all of the scars have been rated, the averages of scars will be
      compared for each closure method. The investigators will also look at how much each method
      cost, how much extra pain medications or sedation each group used, and which method was liked
      best.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: The Plastic Surgeons who rate all scars at the end of the study are blinded to the closure method.
measure: Cosmetic Outcome of Scar at 3 Months
time frame: 3 months
description: Two blinded Plastic Surgeons will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "worst scar" and a score of 100 corresponding to "best scar"
measure: Pain Experienced by Patient as Reported by Parent
time frame: Baseline
description: Parents will each be asked to score how much pain they felt the patient experienced using a 100 mm Visual Analogue Scale with a score of 0 corresponding to "No pain" and a score of 100 corresponding to "Terrible pain."
measure: Satisfaction With Time in the Emergency Department
time frame: Baseline to wound closure, up to 30 minutes
description: Parents will report their satisfaction with Emergency Department length of stay using a 100-point visual analog scale with "100" meaning completely satisfied and "0" meaning not at all satisfied
measure: Likelihood That Parent Would Recommend Laceration Closure Method
time frame: Post-wound closure, approximately 30 minutes
description: Parents will be asked to rate how likely they would be to recommend the closure method used for their child using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "Extremely unlikely" and a score of 100 corresponding to "Extremely likely"
measure: Number of Complications of the Wound Site
time frame: 3 months
description: Parents will be asked by phone at 3 months if there were any complications with their child's cut (infection, opening of the wound, etc.). Investigators will count the number of complications reported.
measure: Parental Reported Satisfaction With the Cosmetic Appearance of the Scar
time frame: 3 months
description: Parents will rate the cosmetic outcome of the laceration using a 0 to 100 mm Visual Analogue Scale with a score of 0 corresponding to "worst scar" and a score of 100 corresponding to "best scar".
measure: Presence of Train Tracks at the Scar Site
time frame: 3 months
description: Plastic Surgeons will record if a scar appears to have "train tracks" (or small dots on either side of a scar, all along the scar, usually caused by stitches) as they are rating each photo of the scar at 3 months post-closure. Surgeons will answer "yes" or "no".
arm group label: Absorbable Sutures
arm group type: Active Comparator
description: Patients will have their laceration closed with sutures that absorb on their own and do not need to be removed.
arm group label: Steri-Strips
arm group type: Experimental
description: Patients will have their laceration closed with a special medical tape called "Steri-Strips."
arm group label: Dermabond
arm group type: Experimental
description: Patients will have their laceration closed with a special skin glue called "Dermabond"
intervention type: Procedure
intervention name: Absorbable Sutures
description: The patient's doctor will close the patient's laceration with absorbable sutures.
arm group label: Absorbable Sutures
other name: Stitches
intervention type: Procedure
intervention name: Steri-Strips
description: The patient's doctor will close the patient's laceration with Steri-Strips.
arm group label: Steri-Strips
other name: Medical tape
intervention type: Procedure
intervention name: Dermabond
description: The patient's doctor will close the patient's laceration with Dermabond.
arm group label: Dermabond
other name: Skin glue
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Holly R Hanson, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Holly Hanson
investigator title: Asst Professor of Clinical Pediatrics
mesh term: Lacerations
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination of the study due to limitation regarding the COVID-19 pandemic and prospective enrollment of pediatric patients in the Emergency Department. There were also only 55% of subjects who performed 3 month follow-up thus our primary outcome can only be measured on these subjects.
point of contact: 