NCT04615338

Brief Summary

It is an observational retrospective multicenter study

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Geographic Reach
2 countries

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2020

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 4, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

1.2 years

First QC Date

October 27, 2020

Last Update Submit

October 21, 2021

Conditions

Neck Injuries

Outcome Measures

Primary Outcomes (8)

  • 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

Study Arms (3)

Homicidal group

The group of patients presented with homicidal open neck injuries

Other: no intervension

Suicidal group

The group of patients presented with suicidal open neck injuries

Other: no intervension

Accidental group

The group of patients presented with accidental open neck injuries

Other: no intervension

Interventions

no intervensionOTHER

no intervention needed just observation and description

Accidental groupHomicidal groupSuicidal group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \) 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.

You may not qualify if:

  • Patients with blunt neck trauma even if causing open wounds
  • Patients with neck burns
  • Patients with previous neck surgeries

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Assiut University Hospital

Asyut, 71516, Egypt

RECRUITING

Manchester royal infirmary

Manchester, M13, United Kingdom

COMPLETED

MeSH Terms

Conditions

Neck Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Ahmed EM Saleh, MSc

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed EM Saleh, MSc

CONTACT

00201007178377ahmed.saleh3@med.au.edu.eg

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician

Study Record Dates

First Submitted

October 27, 2020

First Posted

November 4, 2020

Study Start

October 1, 2020

Primary Completion

December 30, 2021

Study Completion

December 30, 2021

Last Updated

October 26, 2021

Record last verified: 2021-10

Locations

EG(1)GB(1)