NCT05569447

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

June 1, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2021

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2022

Completed
Last Updated

October 7, 2022

Status Verified

October 1, 2022

Enrollment Period

4 months

First QC Date

October 3, 2022

Last Update Submit

October 5, 2022

Conditions

Penetrating Injury Neck

Outcome Measures

Primary Outcomes (1)

  • Mortality

    1 month

Interventions

Balloon TamponadePROCEDURE

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.

Eligibility Criteria

Age50 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Trauma penetrating injury to the neck

You may qualify if:

  • Penetrating Injury to the Neck

You may not qualify if:

  • N?A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

STHS McAllen

McAllen, Texas, 78503, United States

Location

MeSH Terms

Interventions

Balloon Occlusion

Intervention Hierarchy (Ancestors)

CatheterizationTherapeuticsEndotamponadeHemostatic TechniquesEmbolization, TherapeuticTherapeutic OcclusionInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trauma Surgeon

Study Record Dates

First Submitted

October 3, 2022

First Posted

October 6, 2022

Study Start

June 1, 2020

Primary Completion

September 20, 2020

Study Completion

January 20, 2021

Last Updated

October 7, 2022

Record last verified: 2022-10

Locations

US(1)