<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/NCT01685749</url>
  </required_header>
  <id_info>
    <org_study_id>HS#2011-8620</org_study_id>
    <nct_id>NCT01685749</nct_id>
  </id_info>
  <brief_title>The Natural History of Human Stingray Injuries</brief_title>
  <official_title>The Natural History of Human Stingray Injuries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Irvine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Irvine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Stingray injuries can be a hazard shared by many types of beachgoers. Stingrays often lie in&#xD;
      the sand and when stepped on by the unsuspecting beachgoer their tail snaps foreword,&#xD;
      resulting in a barbed stinger injecting venom into the victim. Little exists in the current&#xD;
      literature on the natural history of stingray injuries. Most of the existing literature looks&#xD;
      at the incidence of stings, and to a certain extent the demographic of people who seek care.&#xD;
      To our knowledge no study has attempted to collect a more inclusive population of those&#xD;
      people who are stung and follow them prospectively to determine the incidence of medical&#xD;
      intervention, infection, etc.&#xD;
&#xD;
      This study aims to describe and quantify the natural history of stingray injuries and to&#xD;
      better understand their time course and medical requirements. The study setting will be Seal&#xD;
      Beach, which reports some of the greatest number of annual stingray injuries for any single&#xD;
      beach on the pacific coast. Participants will be identified by the Seal Beach lifeguards who&#xD;
      are believed to treat the majority of stingray injuries suffered at the beach. Eligible&#xD;
      persons will be consented for participation over the phone by research personnel. If enrolled&#xD;
      in the study they will receive a phone call by research personnel one week and one month&#xD;
      after the injury that will collect information about the symptoms they have experienced and&#xD;
      the medical interventions they have received, if any. This study is strictly observational in&#xD;
      nature and will not involve any interventions on the part of study personnel or alter the&#xD;
      manner in which or types of medical assessments or treatments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence and duration of particular symptoms, medical evaluations, and treatment</measure>
    <time_frame>up to 30 days from the date of injury</time_frame>
    <description>This study is descriptive in nature. The primary outcome of this study is the understanding of the natural history of stingray injuries and their treatment. This will be achieved using strictly descriptive statistics of the incidence and duration of particular symptoms, medical evaluations, and treatment. Means, proportions, and confidence intervals of these statistics will be calculated.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Stingray Injury</condition>
  <condition>Marine Envenomation</condition>
  <arm_group>
    <arm_group_label>Enrolled participants</arm_group_label>
    <description>The targeted study population will include all people at Seal Beach who have been identified by the Seal Beach Lifeguards to have been stung by a jellyfish over the course of one year who are adults or children whose parent or guardian is present at the time of the injury. Children and pregnant women are included in the group.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The targeted study population will include all people at Seal Beach who have been&#xD;
        identified by the Seal Beach Lifeguards to have been stung by a stingray over the course of&#xD;
        one year who are adults or children whose parent or guardian is present at the time of the&#xD;
        injury. Children and pregnant women are included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  People at Seal Beach, California&#xD;
&#xD;
          -  People identified by Life guard personnel as being stung by a stingray at Seal Beach&#xD;
&#xD;
          -  Adults or&#xD;
&#xD;
          -  Children whose parent or guardian are present at the time of the injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  People who have previously been enrolled in the study&#xD;
&#xD;
          -  People who the lifeguard believes were stung or bit by a marine organism other than a&#xD;
             stingray or a terrestrial organism&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, Irvine Medical Center</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</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>September 11, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>October 25, 2016</last_update_submitted>
  <last_update_submitted_qc>October 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Irvine</investigator_affiliation>
    <investigator_full_name>Robert J Katzer</investigator_full_name>
    <investigator_title>Emergency Medical Services Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>NO IPD will be shared with other researchers</ipd_description>
  </patient_data>
  <!-- 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/NCT01685749
org study id: HS#2011-8620
nct id: NCT01685749
lead sponsor: 
has dmc: No
Stingray injuries can be a hazard shared by many types of beachgoers. Stingrays often lie in
      the sand and when stepped on by the unsuspecting beachgoer their tail snaps foreword,
      resulting in a barbed stinger injecting venom into the victim. Little exists in the current
      literature on the natural history of stingray injuries. Most of the existing literature looks
      at the incidence of stings, and to a certain extent the demographic of people who seek care.
      To our knowledge no study has attempted to collect a more inclusive population of those
      people who are stung and follow them prospectively to determine the incidence of medical
      intervention, infection, etc.

      This study aims to describe and quantify the natural history of stingray injuries and to
      better understand their time course and medical requirements. The study setting will be Seal
      Beach, which reports some of the greatest number of annual stingray injuries for any single
      beach on the pacific coast. Participants will be identified by the Seal Beach lifeguards who
      are believed to treat the majority of stingray injuries suffered at the beach. Eligible
      persons will be consented for participation over the phone by research personnel. If enrolled
      in the study they will receive a phone call by research personnel one week and one month
      after the injury that will collect information about the symptoms they have experienced and
      the medical interventions they have received, if any. This study is strictly observational in
      nature and will not involve any interventions on the part of study personnel or alter the
      manner in which or types of medical assessments or treatments.
observational model: Case-Only
time perspective: Prospective
measure: Incidence and duration of particular symptoms, medical evaluations, and treatment
time frame: up to 30 days from the date of injury
description: This study is descriptive in nature. The primary outcome of this study is the understanding of the natural history of stingray injuries and their treatment. This will be achieved using strictly descriptive statistics of the incidence and duration of particular symptoms, medical evaluations, and treatment. Means, proportions, and confidence intervals of these statistics will be calculated.
arm group label: Enrolled participants
description: The targeted study population will include all people at Seal Beach who have been identified by the Seal Beach Lifeguards to have been stung by a jellyfish over the course of one year who are adults or children whose parent or guardian is present at the time of the injury. Children and pregnant women are included in the group.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Irvine
investigator full name: Robert J Katzer
investigator title: Emergency Medical Services Fellow
mesh term: Wounds and Injuries
sharing ipd: No
ipd description: NO IPD will be shared with other researchers