Outcomes and Trauma Pattern in Penetrating Neck Injuries

It is an observational retrospective multicenter study

Study Overview

• Status: Recruiting
• Conditions: Neck Injuries
• Intervention / Treatment: Other: no intervension

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 Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Ahmed EM Saleh, MSc; Phone Number: 00201007178377; Email: ahmed.saleh3@med.au.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71516
    • Recruiting
    • Assiut University Hospital
• United Kingdom
  • Manchester, United Kingdom, M13
    • Completed
    • Manchester Royal Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Homicidal group; The group of patients presented with homicidal open neck injuries	Other: no intervension; no intervention needed just observation and description
Suicidal group; The group of patients presented with suicidal open neck injuries	Other: no intervension; no intervention needed just observation and description
Accidental group; The group of patients presented with accidental open neck injuries	Other: no intervension; no intervention needed just observation and description

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Ahmed EM Saleh, MSc, Assiut University

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2020
• Primary Completion (ANTICIPATED): December 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: October 27, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (ACTUAL): November 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 26, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Neck Injuries
• Other Study ID Numbers: Open neck injuries

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No