Outcomes and Trauma Pattern in Penetrating Neck Injuries

Neck Injuries Clinical Trial

Official title:

Outcomes and Trauma Pattern in Penetrating Neck Injuries

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615338
• Other study ID #: Open neck injuries
• Status: Recruiting
• Start date: October 1, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: October 2021
• Source: Assiut University
• Contact: Ahmed EM Saleh, MSc
• Phone: 00201007178377
• Email: ahmed.saleh3[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

It is an observational retrospective multicenter study

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neck Injuries
• Wounds and Injuries

Intervention

Other:
• no intervension
no intervention needed just observation and description

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut
United Kingdom	Manchester royal infirmary	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Countries where clinical trial is conducted

Egypt,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Primary	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	1 year
Primary	compare Site of wounds in different types of trauma	Site of wounds ( in which zone of the neck 1,2,3)	1 year
Primary	compare Number of wounds	Number of wounds	1 year
Primary	compare length of wound in different types of trauma	Length of each wound in cm	1 year
Primary	compare depth of wounds in different types of trauma	depth of each wound ( superficial or deep to platysma)	1 year
Primary	compare number of wound outside the neck i	Number of wounds outside the neck	1 year
Primary	Collect finding in neck exploration	Colect the finding that were found in neck exploration surgeries	1 year