Penetrating Injury NeckNCT05569447
Tree Branch Penetrating Injury
An observational study of Penetrating Injury Neck, run by South Texas Health System McAllen at 1 site in United States.
Trial summary
Penetrating trauma to the neck can result in severe morbidity and mortality. Location of the injury dictates the appropriate clinical management. Challenging traumatic injuries require resourceful treatment options Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Penetrating Injury Neck
- What is being tested?
- Balloon Tamponade
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2020to 20 Jan 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Trauma penetrating injury to the neck
Who may be able to join
- Penetrating Injury to the Neck
Who cannot join
- N?A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tree Branch Penetrating Injury Into Zone III of the Neck
Penetrating trauma to the neck can result in severe morbidity and mortality. Location of the injury dictates the appropriate clinical management. Challenging traumatic injuries require resourceful treatment options
Read the detailed description
A complex traumatic case of a foreign body penetrating the neck, the parotid gland, disrupting the internal jugular vein, with the tip resting at the anterior aspect of the C1 ring is reported. In this case, the authors seek to describe the clinical management of a vascular injury that resulted from penetrating zone III of the neck.
Due to the complex and dense presence of various structure in the neck, injuries can be difficult to manage. Thus, an algorithm identifies management strategies that are suggested based on the location of the injury, signs of vascular injury, identified injured structures and the hemodynamic stability of the patient. Balloon tamponade has been described in other organs of the body and it might be a therapeuticn option in patients were venous injuries are difficult to access.
Penetrating neck injuries continue to result in significant morbidity and mortality. However, with appropriate and efficient evaluation and management, better outcomes are expected as demonstrated in this case.
- Conditions
- Penetrating Injury Neck
- Being tested
- Balloon Tamponade
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balloon TamponadeProcedure or surgery
A tamponade device that was fashioned using an 18F red rubber catheter and Penrose drain that was cut to the approximate length of the tract and ligated proximally and distally with #0 silk.
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start1 Jun 2020
- Primary completion20 Sep 2020
- Study completion20 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penetrating Injury NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- South Texas Health System McAllen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Carlos H. Palacio, South Texas Health System McAllen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05569447
- Sponsor's protocol ID
- D-22-01107
- Status last verified
- Oct 2022
- First submitted
- 3 Oct 2022
- Last updated
- 7 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tree Branch Penetrating Injury Into Zone III of the Neck
- ClinicalTrials.gov ID
- NCT05569447
- Acronym / sponsor ID
- D-22-01107
- Conditions
- Penetrating Injury Neck
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- South Texas Health System McAllenUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 20 Jan 2021 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Penetrating trauma to the neck can result in severe morbidity and mortality. Location of the injury dictates the appropriate clinical management. Challenging traumatic injuries require resourceful treatment options
Detailed description
A complex traumatic case of a foreign body penetrating the neck, the parotid gland, disrupting the internal jugular vein, with the tip resting at the anterior aspect of the C1 ring is reported. In this case, the authors seek to describe the clinical management of a vascular injury that resulted from penetrating zone III of the neck.
Due to the complex and dense presence of various structure in the neck, injuries can be difficult to manage. Thus, an algorithm identifies management strategies that are suggested based on the location of the injury, signs of vascular injury, identified injured structures and the hemodynamic stability of the patient. Balloon tamponade has been described in other organs of the body and it might be a therapeuticn option in patients were venous injuries are difficult to access.
Penetrating neck injuries continue to result in significant morbidity and mortality. However, with appropriate and efficient evaluation and management, better outcomes are expected as demonstrated in this case.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Trauma penetrating injury to the neck
Key inclusion criteria (1 listed)
- Penetrating Injury to the Neck
Key exclusion criteria (1 listed)
- N?A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balloon TamponadeA tamponade device that was fashioned using an 18F red rubber catheter and Penrose drain that was cut to the approximate length of the tract and ligated proximally and distally with #0 silk. | Procedure or surgery | – |
Primary outcome
Mortality
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Penetrating Injury Neck, run by South Texas Health System McAllen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2022.