From Great Surgeons to Brilliant Observators, Evolution of Penetrating Neck Trauma in a Single Center Reference in Spain (PNT-HMAR)

January 18, 2024 updated by: Ana María González Castillo, Hospital del Mar
Penetrating neck trauma ranges from 5 to 10% of trauma patients and its management has been changing in the las 20 years and not all surgeons that attend this patients are trauma surgeons. The aim of the study is to describe the evolution of the management in a referal center and the complications of two periods, with and without a simplified protocol.

Study Overview

Status

Not yet recruiting

Conditions

Detailed Description

Penetrating neck trauma ranges from 5 to 10% of trauma patients and its management has been changing in the las 20 years and not all surgeons that attend this patients are trauma surgeons.

Traditionally, the management was followed by surgical treatment, but the non-therapeutic cervicotomies were ascendent to the 89%, the zone approach was established, following the Monson anatomy zones, with different indications for surgery in every zone, and finally, after the year 2000, started to publish articles on where the injury was not correlated with the zone in about a 23% of the patients.

The aim of the study is to describe the evolution of the management in a referal center and the complications of two periods, with and without a simplified no zone approach protocol.

Study Type

Observational

Enrollment (Estimated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with a penetrating trauma in the neck admitted in Hospital del Mar from 2008 to 2022.

Description

Inclusion Criteria:

  • All penetrating trauma patients admitted in the emergency department.

Exclusion Criteria:

  • All patients with any other diagnostic different from penetrating trauma
  • Blunt trauma patients admitted in the emergency department

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications
Time Frame: 2008-2022
The main outcome measure was the total of complications in patients with a penetrating neck trauma assessed by the Clavien-Dindo Classification.
2008-2022
Mortality
Time Frame: 2008-2022
The second main outcome measure was the total of deaths in patients with a penetrating neck trauma assessed by preventable or non-preventable deaths.
2008-2022
Non-therapeutic cervicotomy
Time Frame: 2008-2022
The third main outcome measure was the total of non-therapeutic and therapeutic cervitocomies before and after implementing a simplified protocol in patients with a penetrating neck trauma.
2008-2022

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographyc description
Time Frame: 2008-2022
Description of the age and gender (Male / Female)
2008-2022
Physiologic description
Time Frame: 2008-2022
Description of the vitals at arrival (bates per minute, blood pressure)
2008-2022
Wound
Time Frame: 2008-2022
Description of the wound: bleeding, longitude, number of wounds
2008-2022

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital del Mar

Investigators

  • Principal Investigator: Ana María González Castillo, Hospital del Mar

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 20, 2024

Primary Completion (Estimated)

May 30, 2024

Study Completion (Estimated)

June 15, 2024

Study Registration Dates

First Submitted

January 18, 2024

First Submitted That Met QC Criteria

January 18, 2024

First Posted (Estimated)

January 29, 2024

Study Record Updates

Last Update Posted (Estimated)

January 29, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Penetrating neck trauma HMAR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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