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Non-missile Penetrating Head Trauma,Cases Registry in Sohag University Hospital (trauma)

Primary Purpose

Head Injuries With Non Missile Penetrating Objjects

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Debridement and dural repair
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head Injuries With Non Missile Penetrating Objjects focused on measuring Penetrating brain trauma (PBT),Traumatic brain injury (TBI), Intensive care unit, non missile.

Eligibility Criteria

4 Years - 39 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Any patient with penetrating head trauma

Exclusion Criteria:

  • missile penetrating head injuries

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Debridement

    Arm Description

    Outcomes

    Primary Outcome Measures

    (Glasgow Coma Scale)(GCS) to evaluate non-Missile Penetrating Brain Injuries
    Descriptive scale grades from (3 to 15). 3 is worst and 15 is the best

    Secondary Outcome Measures

    Full Information

    First Posted
    December 4, 2018
    Last Updated
    December 6, 2018
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03768778
    Brief Title
    Non-missile Penetrating Head Trauma,Cases Registry in Sohag University Hospital
    Acronym
    trauma
    Official Title
    Non-Missile Penetrating Brain Injuries, Cases Registry in Sohag University Hospital
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    November 1, 2012 (Actual)
    Primary Completion Date
    October 1, 2014 (Actual)
    Study Completion Date
    October 1, 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Head Injuries With Non Missile Penetrating Objjects
    Keywords
    Penetrating brain trauma (PBT),Traumatic brain injury (TBI), Intensive care unit, non missile.

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    18 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Debridement
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    Debridement and dural repair
    Other Intervention Name(s)
    Removal of foreign bodies with dural and vascular repair
    Primary Outcome Measure Information:
    Title
    (Glasgow Coma Scale)(GCS) to evaluate non-Missile Penetrating Brain Injuries
    Description
    Descriptive scale grades from (3 to 15). 3 is worst and 15 is the best
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    4 Years
    Maximum Age & Unit of Time
    39 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Any patient with penetrating head trauma Exclusion Criteria: missile penetrating head injuries

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Non-missile Penetrating Head Trauma,Cases Registry in Sohag University Hospital

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