Neck InjuriesNCT04615338
Outcomes and Trauma Pattern in Penetrating Neck Injuries
An observational study of Neck Injuries, run by Assiut University at 2 sites in 2 countries.
Trial summary
It is an observational retrospective multicenter study Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neck Injuries
- What is being tested?
- no intervension
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Oct 2020to 30 Dec 2021
- How long will I take part?
- 30 Days
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients presented with open neck injuries regardless the cause of injury then will be categorized in to 3 groups according to the cause of trauma
Who may be able to join
- 1) All age groups regardless of sex. 2) Homicidal, suicidal and accidental type of trauma. 3) Patients with penetrating neck injuries due to sharp objects trauma. 4) Poly trauma patients having multiple body trauma as well as neck trauma will be included.
- Exclusion criteria:
- Patients with blunt neck trauma even if causing open wounds
- Patients with neck burns
- Patients with previous neck surgeries
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Egypt1 site, 1 recruiting
- Recruiting
Assiut University Hospital
Asyut, 71516
Ahmed Saleh, MSc, 002010071787377, ahmed.saleh3@med.au.edu.eg
United Kingdom1 site
- Completed
Manchester royal infirmary
Manchester, M13
About this study
It is an observational retrospective multicenter study
Read the detailed description
It is an observational descriptive, retrospective study. The study will be conducted in two centers: the Emergency and accident unit and Head and neck surgical unit Manchester Royal infirmary, Manchester, United Kingdom and Trauma unit and Otolaryngology department Assiut university Hospital, Assiut, Egypt. The study will include all the patients presented to both centers with open neck trauma in duration between April 2018 and October 2020. The following items recorded: gender, age, type of trauma (whether it is homicidal, suicidal, accidental trauma), time of the day the patients presented, Previous philological disorder in patients with suicidal types of trauma, number of neck wounds, site of the wounds ( in relation to the zones of the neck), size of each wound in centimeter, whether the wounds are deep or superficial to platysma, length of stay in the hospital, , injuries to any neck structures injuries in other parts of the body, involvement of other teams in management of the patent and type of involvement. Also the need of airway support (either intubation or tracheostomy), immediate and long term complications of the injury and if the patients needed neck exploration or just suturing of the wounds under local anesthesia.
Data of the patients who needed exploration will be reviewed to detect finding in neck exploration and try to find out the criteria of the patients who needed neck exploration and put a clear protocol for management.
The included patients will be categorized into 3 groups according to type of trauma (suicidal, homicidal or accidental) all the recorded data will be compared to detect the outcomes in each type of trauma and if there is a specific pattern of trauma in each category.
The study will be conducted after obtaining an institutional review board (IRB) approval from the committee of medical ethics, faculty of medicine, Assiut University. The study and all interventions and surgical procedures within it were done by scientifically qualified and trained personnel. The is no additional risk for participating in the study as it is a descriptive study
- Conditions
- Neck Injuries
- Being tested
- no intervension
- Medical subject headings
- Neck Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervensionOther
no intervention needed just observation and description
| Study group | Role | What they receive |
|---|---|---|
| Homicidal group | The group of patients presented with homicidal open neck injuries Receives: Other: no intervension | |
| Suicidal group | The group of patients presented with suicidal open neck injuries Receives: Other: no intervension | |
| Accidental group | The group of patients presented with accidental open neck injuries Receives: Other: no intervension |
What is being measured
The primary outcome is the main question the study is designed to answer.
compare duration of the stay in the hospital in different types of open neck injuries
Duration of the stay of the patient in the hospital in days
Measured: 1 year
compare fate of trauma in different types of open neck injuries
The fate of the trauma if the patient survived or died and if survived with long term complication
Measured: 1 year
compare Site of wounds in different types of trauma
Site of wounds ( in which zone of the neck 1,2,3)
Measured: 1 year
compare Number of wounds
Number of wounds
Measured: 1 year
compare length of wound in different types of trauma
Length of each wound in cm
Measured: 1 year
compare depth of wounds in different types of trauma
depth of each wound ( superficial or deep to platysma)
Measured: 1 year
compare number of wound outside the neck i
Number of wounds outside the neck
Measured: 1 year
Collect finding in neck exploration
Colect the finding that were found in neck exploration surgeries
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Oct 2020
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck InjuriesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ezzat Mohamed Saleh, Assiut University
- Investigators
- Ahmed EM Saleh, MSc, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615338
- Sponsor's protocol ID
- Open neck injuries
- Status last verified
- Oct 2021
- First submitted
- 27 Oct 2020
- Last updated
- 26 Oct 2021
- 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 26 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Trauma Pattern in Penetrating Neck Injuries
- ClinicalTrials.gov ID
- NCT04615338
- Acronym / sponsor ID
- Open neck injuries
- Conditions
- Neck Injuries
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2021 (estimated)
- First posted
- 4 Nov 2020 (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.
It is an observational retrospective multicenter study
Detailed description
It is an observational descriptive, retrospective study. The study will be conducted in two centers: the Emergency and accident unit and Head and neck surgical unit Manchester Royal infirmary, Manchester, United Kingdom and Trauma unit and Otolaryngology department Assiut university Hospital, Assiut, Egypt. The study will include all the patients presented to both centers with open neck trauma in duration between April 2018 and October 2020. The following items recorded: gender, age, type of trauma (whether it is homicidal, suicidal, accidental trauma), time of the day the patients presented, Previous philological disorder in patients with suicidal types of trauma, number of neck wounds, site of the wounds ( in relation to the zones of the neck), size of each wound in centimeter, whether the wounds are deep or superficial to platysma, length of stay in the hospital, , injuries to any neck structures injuries in other parts of the body, involvement of other teams in management of the patent and type of involvement. Also the need of airway support (either intubation or tracheostomy), immediate and long term complications of the injury and if the patients needed neck exploration or just suturing of the wounds under local anesthesia.
Data of the patients who needed exploration will be reviewed to detect finding in neck exploration and try to find out the criteria of the patients who needed neck exploration and put a clear protocol for management.
The included patients will be categorized into 3 groups according to type of trauma (suicidal, homicidal or accidental) all the recorded data will be compared to detect the outcomes in each type of trauma and if there is a specific pattern of trauma in each category.
The study will be conducted after obtaining an institutional review board (IRB) approval from the committee of medical ethics, faculty of medicine, Assiut University. The study and all interventions and surgical procedures within it were done by scientifically qualified and trained personnel. The is no additional risk for participating in the study as it is a descriptive study
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 30 Days
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Homicidal group | – | Other: no intervensionThe group of patients presented with homicidal open neck injuries |
| Suicidal group | – | Other: no intervensionThe group of patients presented with suicidal open neck injuries |
| Accidental group | – | Other: no intervensionThe group of patients presented with accidental open neck injuries |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients presented with open neck injuries regardless the cause of injury then will be categorized in to 3 groups according to the cause of trauma
Key inclusion criteria (5 listed)
- 1) All age groups regardless of sex. 2) Homicidal, suicidal and accidental type of trauma. 3) Patients with penetrating neck injuries due to sharp objects trauma. 4) Poly trauma patients having multiple body trauma as well as neck trauma will be included.
- Exclusion criteria:
- Patients with blunt neck trauma even if causing open wounds
- Patients with neck burns
- Patients with previous neck surgeries
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| no intervensionno intervention needed just observation and description | Other | Accidental group, Homicidal group, Suicidal group |
Primary outcome
compare duration of the stay in the hospital in different types of open neck injuries
Time frame: 1 year
Duration of the stay of the patient in the hospital in days
compare fate of trauma in different types of open neck injuries
Time frame: 1 year
The fate of the trauma if the patient survived or died and if survived with long term complication
compare Site of wounds in different types of trauma
Time frame: 1 year
Site of wounds ( in which zone of the neck 1,2,3)
compare Number of wounds
Time frame: 1 year
Number of wounds
compare length of wound in different types of trauma
Time frame: 1 year
Length of each wound in cm
compare depth of wounds in different types of trauma
Time frame: 1 year
depth of each wound ( superficial or deep to platysma)
compare number of wound outside the neck i
Time frame: 1 year
Number of wounds outside the neck
Collect finding in neck exploration
Time frame: 1 year
Colect the finding that were found in neck exploration surgeries
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Neck Injuries
RecruitingPhase 3
A Trial Investigating the Efficacy and Safety of NVG-291 in Subjects With Chronic Spinal Cord Injury
Chronic Spinal Cord Injury
Not yet recruiting
Influence of Transcranial Electrical Stimulation on Arm and Hand Function After Cervical Spinal Cord Injury
Spinal Cord Injury
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
RecruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
Active, not recruiting
Lumbar-Sacral Plexus Block vs Fascia Iliaca Block Plus Low-Dose Spinal Anesthesia for Femoral Neck Fracture Surgery
Femoral Neck Fractures, Nerve Block
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.
Ahmed EM Saleh, MSc principal investigator
Assiut University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neck Injuries, run by Assiut University at 2 sites in 2 countries.
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 5 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 26 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed EM Saleh, MSc (00201007178377, ahmed.saleh3@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
compare duration of the stay in the hospital in different types of open neck injuries (time frame: 1 year). The study lists 8 primary outcomes in all. 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 26 Oct 2021.