<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/NCT01721083</url>
  </required_header>
  <id_info>
    <org_study_id>DDD# 602056</org_study_id>
    <nct_id>NCT01721083</nct_id>
  </id_info>
  <brief_title>Comparison of Two Methods of Immunization for Intramuscular Injections</brief_title>
  <official_title>Comparison of Two Methods of Immunization for Intramuscular Injections</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christiana Care Health Services</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Christiana Care Health Services</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to compare two different styles of intramuscular injection (Bunch&#xD;
      versus Z-Track)during flu vaccination with the following outcome measures as basis for&#xD;
      comparison: perceive pain, redness, medication leakage, other complications within 72 hours&#xD;
      in healthy adult volunteer subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is designed to compare two different styles of intramuscular injection (Bunch&#xD;
      versus Z-Track)during flu vaccination with the following outcome measures as basis for&#xD;
      comparison: perceive pain, redness, medication leakage, other complications within 72 hours&#xD;
      in healthy adult volunteer subjects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <phase>Phase 4</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>Health Services Research</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived pain</measure>
    <time_frame>72 hours</time_frame>
    <description>Subjects will be asked to rate perceived pain on scale of 0-10</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medication leakage</measure>
    <time_frame>72 hours</time_frame>
    <description>Any medication leakage from either arm within 72 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Redness at injection site</measure>
    <time_frame>72 hours</time_frame>
    <description>Redness, as determined by naive observer at injection site immediately and up to 72 hours after study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">511</enrollment>
  <condition>Consequences of Immunization Method</condition>
  <arm_group>
    <arm_group_label>Z-Track immunization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subject receives Intramuscular injection by z-track method during flu vaccination given by employee health Registered Nurse into deltoid muscle.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bunch immunization</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subject receives Intramuscular injection by bunch method during flu vaccination given by employee health Registered Nurse into deltoid muscle.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Procedure: Z-track</intervention_name>
    <description>Subject received immunization by z-track</description>
    <arm_group_label>Z-Track immunization</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Procedure: Bunch</intervention_name>
    <description>Subject receives immunization by bunch method.</description>
    <arm_group_label>Bunch immunization</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy adults without latex allergy over 18 years of age&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  latex allergy&#xD;
&#xD;
          -  illness&#xD;
&#xD;
          -  18 years or less&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lynn E Bayne, PhD, ARNP, NNP-BC</last_name>
    <role>Principal Investigator</role>
    <affiliation>Christiana Care Health Services</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Christiana Care Health System</name>
      <address>
        <city>Newark</city>
        <state>Delaware</state>
        <zip>19716</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 2, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 4, 2012</study_first_posted>
  <last_update_submitted>July 15, 2014</last_update_submitted>
  <last_update_submitted_qc>July 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>intramuscular injection</keyword>
  <keyword>bunch</keyword>
  <keyword>z-track</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT01721083
org study id: DDD# 602056
nct id: NCT01721083
lead sponsor: 
has dmc: No
This study is designed to compare two different styles of intramuscular injection (Bunch
      versus Z-Track)during flu vaccination with the following outcome measures as basis for
      comparison: perceive pain, redness, medication leakage, other complications within 72 hours
      in healthy adult volunteer subjects.
This study is designed to compare two different styles of intramuscular injection (Bunch
      versus Z-Track)during flu vaccination with the following outcome measures as basis for
      comparison: perceive pain, redness, medication leakage, other complications within 72 hours
      in healthy adult volunteer subjects.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: Double (Participant, Outcomes Assessor)
measure: Perceived pain
time frame: 72 hours
description: Subjects will be asked to rate perceived pain on scale of 0-10
measure: Medication leakage
time frame: 72 hours
description: Any medication leakage from either arm within 72 hours
measure: Redness at injection site
time frame: 72 hours
description: Redness, as determined by naive observer at injection site immediately and up to 72 hours after study.
arm group label: Z-Track immunization
arm group type: Experimental
description: Subject receives Intramuscular injection by z-track method during flu vaccination given by employee health Registered Nurse into deltoid muscle.
arm group label: Bunch immunization
arm group type: Active Comparator
description: Subject receives Intramuscular injection by bunch method during flu vaccination given by employee health Registered Nurse into deltoid muscle.
intervention type: Procedure
intervention name: Procedure: Z-track
description: Subject received immunization by z-track
arm group label: Z-Track immunization
intervention type: Procedure
intervention name: Procedure: Bunch
description: Subject receives immunization by bunch method.
arm group label: Bunch immunization
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Lynn E Bayne, PhD, ARNP, NNP-BC
role: Principal Investigator
affiliation: Christiana Care Health Services
facility: 
country: United States
responsible party type: Sponsor