Head Injuries With Non Missile Penetrating ObjjectstraumaNCT03768778
Non-missile Penetrating Head Trauma,Cases Registry in Sohag University Hospital
A study testing Debridement and dural repair in people with Head Injuries With Non Missile Penetrating Objjects, run by Sohag University.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Head Injuries With Non Missile Penetrating Objjects
- What is being tested?
- Debridement and dural repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2012to 1 Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 39 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Any patient with penetrating head trauma
Who cannot join
- missile penetrating head injuries
About this study
Official title: Non-Missile Penetrating Brain Injuries, Cases Registry in Sohag University Hospital
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.
Read the 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.
- Being tested
- Debridement and dural repair
- Keywords
- Penetrating brain trauma (PBT),Traumatic brain injury (TBI), Intensive care unit, non missile.
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debridement and dural repairProcedure or surgery
Also called Removal of foreign bodies with dural and vascular repair
| Study group | Role | What they receive |
|---|---|---|
| Debridement | Other | Not described Receives: Procedure: Debridement and dural repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
(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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start1 Nov 2012
- Primary completion1 Oct 2014
- Study completion1 Oct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head Injuries With Non Missile Penetrating ObjjectsStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed salaheldin mohammed saro, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03768778
- Sponsor's protocol ID
- Sohag1
- Acronym
- trauma
- Status last verified
- Dec 2018
- First submitted
- 4 Dec 2018
- Last updated
- 10 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Missile Penetrating Brain Injuries, Cases Registry in Sohag University Hospital
- ClinicalTrials.gov ID
- NCT03768778
- Acronym / sponsor ID
- trauma / Sohag1
- Keywords
- Penetrating brain trauma (PBT),Traumatic brain injury (TBI), Intensive care unit, non missile.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 1 Oct 2014 (actual)
- Study completion
- 1 Oct 2014 (actual)
- First posted
- 7 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Debridement | Other | Procedure: Debridement and dural repair |
Who may qualify
- Ages
- 4 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Any patient with penetrating head trauma
Key exclusion criteria (1 listed)
- missile penetrating head injuries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debridement and dural repairAlso: Removal of foreign bodies with dural and vascular repair | Procedure or surgery | Debridement |
Primary outcome
(Glasgow Coma Scale)(GCS) to evaluate non-Missile Penetrating Brain Injuries
Time frame: 2 years
Descriptive scale grades from (3 to 15). 3 is worst and 15 is the best
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Debridement and dural repair in people with Head Injuries With Non Missile Penetrating Objjects, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Glasgow Coma Scale)(GCS) to evaluate non-Missile Penetrating Brain Injuries (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2018.