NCT05954936

Brief Summary

Introduction: Injuries are a leading cause of mortality worldwide. It is necessary to know the incidence of injuries, mechanisms of wounds, therapy provided, and outcomes. Trauma registries are useful to describe the population served in specialized centers. Nevertheless, it is necessary also to identify the peculiarities of the event in the province and institutions non-dedicated to trauma attention. Objective: The study aims to describe the initial experience with a trauma register in a general hospital in the Colombian Orinoquia. Methodology: The investigators designed an observational retrospective study to analyze the admission database and revision of history charts of patients older than 15 years admitted for trauma from January to June 2023 in a hospital from Villavicencio, Colombia. The information will be exported to Excel for debugging and analysis. A description of the frequency and proportion of categorical variables will be performed; the central distribution and dispersion of quantitative variables will be reported. U of Mann-Whitney and Chi-square tests will be used to compare the variables by outcome; a p\<0.05 was selected as a significant value. Conclusions: It will be a pioneer study in this region, and it is necessary to evaluate the incidence of patients admitted by trauma, the mechanisms and type of injury, the care provided, and the outcomes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

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

First Submitted

Initial submission to the registry

July 11, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
Last Updated

December 12, 2024

Status Verified

December 1, 2024

Enrollment Period

7 months

First QC Date

July 11, 2023

Last Update Submit

December 9, 2024

Conditions

Keywords

Wounds and InjuriesTrauma Severity IndicesTrauma CentersMultiple TraumaRegistriesData CollectionRoutinely Collected Health DataColombia

Outcome Measures

Primary Outcomes (1)

  • Number of patients dead

    Mortality on discharge or the first 28 days of hospitalization

    28 days or discharge

Secondary Outcomes (5)

  • Number of days in hospitalization

    28 days or discharge

  • Number of patients needing ICU

    28 days or discharge

  • Number of days in ICU

    28 days or discharge

  • Number of patients needing mechanical ventilation

    28 days or discharge

  • Number of days in mechanical ventilation

    28 days or discharge

Study Arms (2)

Blunt injury

Patients with non-penetrating injuries from falls, car accidents, or other mechanisms. Injuries that were caused by impact with a blunt object where there is no penetration of the skin.

Other: Risk factor

Penetrating injury

Penetrating wounds by guns, knives, and other penetrating injuries. Wounds that were caused by objects penetrating the skin.

Other: Risk factor

Interventions

No therapeutic or diagnostic intervention will be provided; it is an observational study.

Blunt injuryPenetrating injury

Eligibility Criteria

Age16 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The trial participants are those admitted requesting emergency attention by trauma during the study period, according to the registers of admission in the institution.

You may qualify if:

  • Patients admitted to the emergency ward by trauma.

You may not qualify if:

  • None.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinica Primavera

Villavicencio, Meta Department, 50001, Colombia

Location

Related Publications (11)

  • Ordonez CA, Morales M, Rojas-Mirquez JC, Bonilla-Escobar FJ, Badiel M, Minan Arana F, Gonzalez A, Pino LF, Uribe-Gomez A, Herrera MA, Gutierrez-Martinez MI, Puyana JC, Abutanos M, Ivatury RR. Trauma Registry of the Pan-American Trauma Society: One year of experience in two hospitals in southwest Colombia. Colomb Med (Cali). 2016 Sep 30;47(3):148-154.

  • Uribe A, Ordóñez CA, Badiel M, Tejada JW, Harry Loaiza J, Fernando Pino L, et al. Tendencia del trauma en dos hospitales nivel IV en Cali, Colombia. Reporte preliminar en la Plataforma del Registro de la Sociedad Panamericana de Trauma (SPT/RT). Panam J Trauma Crit Care Emerg Surg. 2012;1(3):175-81.

    RESULT
  • Christey G, Warren J, Palmer CS, Burrell M, Vallmuur K. Development of a standardized minimum dataset for including low-severity trauma patients in trauma registry collections in Australia and Aotearoa New Zealand. ANZ J Surg. 2023 Mar;93(3):572-576. doi: 10.1111/ans.18326. Epub 2023 Mar 1.

  • Ordóñez CA, Botache WF, Pino LF, Badiel M, Tejada JW, Sanjuán J, et al. Experiencia en dos hospitales de tercer nivel de atención del suroccidente de Colombia en la aplicación del Registro Internacional de Trauma de la Sociedad Panamericana de Trauma. Rev Colomb Cir. 2013;28(1):39-47.

    RESULT
  • Eyler L, Hubbard A, Juillard C. Assessment of economic status in trauma registries: A new algorithm for generating population-specific clustering-based models of economic status for time-constrained low-resource settings. Int J Med Inform. 2016 Oct;94:49-58. doi: 10.1016/j.ijmedinf.2016.05.004. Epub 2016 Jun 29.

  • Carius BM, Bebarta GE, April MD, Fisher AD, Rizzo J, Ketter P, Wenke JC, Salinas J, Bebarta VS, Schauer SG. A Retrospective Analysis of Combat Injury Patterns and Prehospital Interventions Associated with the Development of Sepsis. Prehosp Emerg Care. 2023;27(1):18-23. doi: 10.1080/10903127.2021.2001612. Epub 2021 Dec 22.

  • Arbizu-Fernandez E, Echarri-Sucunza A, Galbete A, Fortun-Moral M, Belzunegui-Otano T. Epidemiology of severe trauma in Navarra for 10 years: out-of-hospital/ in-hospital deaths and survivors. BMC Emerg Med. 2023 May 24;23(1):54. doi: 10.1186/s12873-023-00818-6.

  • Mandavia D, Newton K. Geriatric trauma. Emerg Med Clin North Am. 1998 Feb;16(1):257-74. doi: 10.1016/s0733-8627(05)70358-8.

  • Cleves D, Gomez C, Davalos DM, Garcia X, Astudillo RE. Pediatric trauma at a general hospital in Cali, Colombia. J Pediatr Surg. 2016 Aug;51(8):1341-5. doi: 10.1016/j.jpedsurg.2016.01.008. Epub 2016 Feb 3.

  • Benjamin ER, Demetriades D, Owattanapanich N, Shackelford SA, Roedel E, Polk TM, Biswas S, Rasmussen T. Therapeutic Interventions and Outcomes in Civilian and Military Isolated Gunshot Wounds to the Head: A Department of Defense Trauma Registry and ACS TQIP-matched Study. Ann Surg. 2023 Jul 1;278(1):e131-e136. doi: 10.1097/SLA.0000000000005496. Epub 2022 Jul 4.

  • Fitschen-Oestern S, Lippross S, Lefering R, Kluter T, Weuster M, Franke GM, Kirsten N, Muller M, Schroder O, Seekamp A; TraumaRegister DGU. Does the time of the day affect multiple trauma care in hospitals? A retrospective analysis of data from the TraumaRegister DGU(R). BMC Emerg Med. 2021 Nov 13;21(1):134. doi: 10.1186/s12873-021-00525-0.

MeSH Terms

Conditions

Wounds and InjuriesWounds, NonpenetratingWounds, PenetratingMultiple Trauma

Interventions

Risk Factors

Intervention Hierarchy (Ancestors)

RiskProbabilityStatistics as TopicEpidemiologic MethodsInvestigative TechniquesCausalityEpidemiologic FactorsQuality of Health CareHealth Care Quality, Access, and EvaluationHealth Care Evaluation MechanismsPublic HealthEnvironment and Public Health

Study Officials

  • Norton Perez, MD

    Cooperative University of Colombia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 11, 2023

First Posted

July 20, 2023

Study Start

January 1, 2024

Primary Completion

July 30, 2024

Study Completion

August 31, 2024

Last Updated

December 12, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Database will not be shared to provide confidentiality to the identity of patients.

Locations