Clinical trial NCT04615338: Outcomes and Trauma Pattern in Penetrating Neck Injuries
Official title: Outcomes and Trauma Pattern in Penetrating Neck Injuries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neck Injuries
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief summary: 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

Eligibility criteria: Inclusion criteria:

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.

b. Exclusion criteria:

1. Patients with blunt neck trauma even if causing open wounds
2. Patients with neck burns
3. Patients with previous neck surgeries

Primary outcomes:
measure: compare duration of the stay in the hospital in different types of open neck injuries
timeFrame: 1 year
measure: compare fate of trauma in different types of open neck injuries
timeFrame: 1 year
measure: compare Site of wounds in different types of trauma
timeFrame: 1 year
measure: compare Number of wounds
timeFrame: 1 year
measure: compare length of wound in different types of trauma
timeFrame: 1 year
measure: compare depth of wounds in different types of trauma
timeFrame: 1 year
measure: compare number of wound outside the neck i
timeFrame: 1 year
measure: Collect finding in neck exploration
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University Hospital
city: Manchester
country: United Kingdom
facility: Manchester royal infirmary
Study officials:
affiliation: Assiut University
name: Ahmed EM Saleh, MSc
role: PRINCIPAL_INVESTIGATOR
References: