<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/NCT03768778</url>
  </required_header>
  <id_info>
    <org_study_id>Sohag1</org_study_id>
    <nct_id>NCT03768778</nct_id>
  </id_info>
  <brief_title>Non-missile Penetrating Head Trauma,Cases Registry in Sohag University Hospital</brief_title>
  <acronym>trauma</acronym>
  <official_title>Non-Missile Penetrating Brain Injuries, Cases Registry in Sohag University Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sohag University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sohag University</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>
      A retrospective study was done in Neurosurgery trauma unit, Sohag University. Eighteen&#xD;
      patients reported with different mechanisms of trauma. All patients clinically tested&#xD;
      involving neurological evaluation. Computed tomography brain was done for them at the time of&#xD;
      admission. Cautious removal of the penetrating object with local debridement of surrounding&#xD;
      tissues including skin, skull, dura and brain tissue and watertight closure of the dura&#xD;
      should be done. Patients transferred to the Intensive care unit (ICU) for 48 - 72 hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traumatic intracranial penetration of foreign non-missile object rarely occurs. Early&#xD;
      mortality may be caused by hemorrhages, major vascular injury or contusions; while epileptic&#xD;
      seizures and infections are among the possible complications in later stages. Complete&#xD;
      excision of the foreign object should be done for all patients and any dural and/or vascular&#xD;
      injuries should be repaired during surgical treatment.&#xD;
&#xD;
      Neurological level, hemodynamic and respiratory status at hospital admission, type of&#xD;
      penetrating the object, pupil size, and reactivity, as the CT findings, all these factors&#xD;
      will affect the prognosis so they should be evaluated carefully before the decision of the&#xD;
      line of management. Intracranial infection, CSF leak and recurrent attacks of convulsions are&#xD;
      the most common complications.&#xD;
&#xD;
      Our goal in this study to report cases with non-missile penetrating head injuries and&#xD;
      evaluate the possible predictive factors in a series of 18 patients sustaining penetrating&#xD;
      head injuries, admitted to our hospital over a period of 2 years, to be used as a guide for&#xD;
      the surgical management.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2012</start_date>
  <completion_date type="Actual">October 1, 2014</completion_date>
  <primary_completion_date type="Actual">October 1, 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>(Glasgow Coma Scale)(GCS) to evaluate non-Missile Penetrating Brain Injuries</measure>
    <time_frame>2 years</time_frame>
    <description>Descriptive scale grades from (3 to 15). 3 is worst and 15 is the best</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Head Injuries With Non Missile Penetrating Objjects</condition>
  <arm_group>
    <arm_group_label>Debridement</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Debridement and dural repair</intervention_name>
    <arm_group_label>Debridement</arm_group_label>
    <other_name>Removal of foreign bodies with dural and vascular repair</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient with penetrating head trauma&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  missile penetrating head injuries&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>December 6, 2018</last_update_submitted>
  <last_update_submitted_qc>December 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sohag University</investigator_affiliation>
    <investigator_full_name>ahmed salaheldin mohammed saro</investigator_full_name>
    <investigator_title>Assistant professor of neurosurgery</investigator_title>
  </responsible_party>
  <keyword>Penetrating brain trauma (PBT),Traumatic brain injury (TBI), Intensive care unit, non missile.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Craniocerebral Trauma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03768778
org study id: Sohag1
nct id: NCT03768778
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A retrospective study was done in Neurosurgery trauma unit, Sohag University. Eighteen
      patients reported with different mechanisms of trauma. All patients clinically tested
      involving neurological evaluation. Computed tomography brain was done for them at the time of
      admission. Cautious removal of the penetrating object with local debridement of surrounding
      tissues including skin, skull, dura and brain tissue and watertight closure of the dura
      should be done. Patients transferred to the Intensive care unit (ICU) for 48 - 72 hours.
Traumatic intracranial penetration of foreign non-missile object rarely occurs. Early
      mortality may be caused by hemorrhages, major vascular injury or contusions; while epileptic
      seizures and infections are among the possible complications in later stages. Complete
      excision of the foreign object should be done for all patients and any dural and/or vascular
      injuries should be repaired during surgical treatment.

      Neurological level, hemodynamic and respiratory status at hospital admission, type of
      penetrating the object, pupil size, and reactivity, as the CT findings, all these factors
      will affect the prognosis so they should be evaluated carefully before the decision of the
      line of management. Intracranial infection, CSF leak and recurrent attacks of convulsions are
      the most common complications.

      Our goal in this study to report cases with non-missile penetrating head injuries and
      evaluate the possible predictive factors in a series of 18 patients sustaining penetrating
      head injuries, admitted to our hospital over a period of 2 years, to be used as a guide for
      the surgical management.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: (Glasgow Coma Scale)(GCS) to evaluate non-Missile Penetrating Brain Injuries
time frame: 2 years
description: Descriptive scale grades from (3 to 15). 3 is worst and 15 is the best
arm group label: Debridement
arm group type: Other
intervention type: Procedure
intervention name: Debridement and dural repair
arm group label: Debridement
other name: Removal of foreign bodies with dural and vascular repair
criteria: 
gender: All
minimum age: 4 Years
maximum age: 39 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Sohag University
investigator full name: ahmed salaheldin mohammed saro
investigator title: Assistant professor of neurosurgery
mesh term: Craniocerebral Trauma
sharing ipd: Undecided