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
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
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
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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