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Trauma, MultipleGRITNCT03854591

A Snapshot Study of Patients Affected by Gunshot Related Injuries in Trauma in South Africa

An observational study of Trauma, Multiple and Gun Shot Wound, run by University of Cape Town at 1 site in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction- Gun violence represents an important cause of disability to the working age population in South Africa. It has unrecognised, but undoubtedly significant implications for the health service and patients affected by these injuries. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Trauma, Multiple, Gun Shot Wound
How many people
138 participants
Where
1 siteSouth Africa
Study dates
18 Feb 2019to 1 Mar 2020
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 18 years and older
  • All sexes
  • Adult, Older adult

Study population: Any adult patient presenting with at least one gunshot injury to the limb, spine or pelvis

Who may be able to join

  • Any gunshot related injury presenting to registered study hospital's orthopaedic service.

Who cannot join

  • Isolated injuries to the head, chest or abdomen
  • Patients under 18 years of age

Trial locations and contacts

1 site in 1 country.

South Africa1 site
  • Groote Schuur Hospital

    Cape Town, Western Cape, 7925

Other trials in South Africa

About this study

Official title: Gunshot Related Injuries in Trauma

Introduction- Gun violence represents an important cause of disability to the working age population in South Africa. It has unrecognised, but undoubtedly significant implications for the health service and patients affected by these injuries.

Aim- To capture the burden of gunshot injury across South Africa and to establish a network of researchers in this field.

Read more

Method- A cross-sectional observational study run across South Africa capturing a nationwide picture of burden and complications associated with these injuries. Each centre will participate in a two-week window of patient screening and recruitment. Patients will be followed up at 6 weeks as per routine clinical practice. Data collected will include nature and number of treatments, length of stay, return to work and complications.

Results-Outcome of the study will be disseminated to the participating centres, relevant health boards and published with all contributors across centres recognised.

Read the detailed description

Injury is a leading cause of death and morbidity in South Africa. It represents 8% of all cause mortality. Death by injury disproportionately affects young working age people who leave behind dependents. Those who survive their injury may suffer long standing disability. However funding for research in injury accounts for less than 1% percent of the research expenditure of the MRC South Africa. This is particularly incongruous as 'injury' was identified by the Essential National Health Research congress as the number 1 priority for the MRC as far back as 1996.

Causes of injury include work related injury, road accidents and interpersonal violence. Within interpersonal violence, gunshot injuries are a particularly lethal and disabling. South Africa has the 18th highest number of gun owners in the world. However it has a gun homicide rate of 8.2 per hundred thousand. This is comparable to the United States, which has the highest levels of gun ownership anywhere in the world.

This is also the highest number anywhere in Southern Africa. It places South Africa amongst some of the most violent countries in the world such as Honduras and Brazil.

The legacy of gun injuries can be just as devastating to communities with persistent disability and escalating feuds. The health impact of gun related injury has been explored in a few specific centres however the broader national picture remains unclear (4). It seems likely that specific areas will bear most of the gun problem. If this can be sufficiently understood specific interventions resources and expertise can be most appropriately deployed.

RATIONALE FOR CURRENT STUDY Gunshot related injuries are an important cause of mortality and morbidity. In South Africa, this burden is under studied and relatively unique. Most studies focus on death as an outcome for gun related violence, however injuries to limbs as seen by orthopaedic teams are rarely fatal. Unfortunately such injuries are highly significant and cause long term disability for patients. Gunshot injuries are also very resource intensive to treat.

Injury is a significant research priority for South Africa, but currently it receives little funding. There are also no structures in place to study injury and its treatment on a nationwide basis.

This study seeks to build such a network around the clinical problem of gunshot injury. In turn this will act as a platform to deliver big and important clinical effectiveness research for future generations of South African patients.

STUDY OBJECTIVES Primary- To capture on a nationwide basis the burden of orthopaedic gunshot injury in patients.

Secondary- To establish a research collaborative network for Orthopaedic trauma across South Africa.

STUDY METHOD A snap shot cohort study run across participating sites in South Africa. All sites in South Africa offering orthopaedic care have been invited to participate. Each will return anonymised routine data on patients who meet the eligibility criteria over a two week study window. Each patient will be approached for consent as detailed below.

Once open each site will be responsible for recording each patient that meets the inclusion criteria that is referred to the trauma and orthopaedic service.

Outcomes collected will aim to inform both patient level and healthcare system costs in terms of burden of work and legacy of injury.

Each patient will have a unique alphanumeric study number. Against this anonymous identifier, the site data collector(s) will record the data on a secure web based database (REDCap). This safe and secure method will return data to the study coordinating centre.

Consent Each patient will be approached and consent to participate sought. This will cover their agreement to have data recorded; to answer additional questions related to the research objectives both at admission and at follow up. Consent forms will be stored locally. Where patients lack capacity to consent on admission, they will be recorded on the study screening log anonymously. For the duration of their inpatient stay, the clinical team will assess them for recovery of capacity. If the patient dies or fails to recover then only the anonymous screening log data will be recorded in the study. A final attempt to recruit the patient will be made at the 6 week follow up appointment.

Being tested
No intervention
Keywords
GLOBAL SURGERY, COLLABORATIVE RESEARCH, GUNSHOT IN JURY, EPIDEMIOLOGY
Medical subject headings
Multiple Trauma, Wounds, Gunshot

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    No intervention

Study groups in NCT03854591
Study groupRoleWhat they receive
Gunshot related injuryPatients admitted to orthopaedic trauma service with gunshot related injury
Receives: Other: No intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Destination at discharge

    Record of alive, dead or discharged

    Measured: 6 weeks after enrolment to study date

Secondary outcomes (5)
  1. Number of cases

    Total number of gunshot related injuries admitted at each unit

    Measured: 18/02/2019-04/03/2019

  2. Return to follow up

    Number of patients that attend their routine follow up appointment

    Measured: 01/04/2019-15/04/2019

  3. Number of patients who give consent to additional study questions

    Each patient with capacity will be asked to give consent to ask additional questions

    Measured: 18/02/2019-04/03/2019

  4. Health Related Quality of Life

    Baseline and follow up HRQOL will be assessed using the EQ5D assessment where patients have given consent

    Measured: Total study period 18/02/2019-15/04/2019

  5. Complications

    At 6-8 week after index admission window any noted complications will be recorded (including surgical site infection and failure of fixation)

    Measured: Total study period 18/02/2019-15/04/2019

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Feb 2019
  2. Study start18 Feb 2019
  3. Primary completion8 May 2019
  4. Study completion1 Mar 2020

Resources

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
Prospective
Enrolment
138 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03854591
Sponsor's protocol ID
755/2018
Acronym
GRIT
Status last verified
Apr 2021
First submitted
20 Feb 2019
Last updated
28 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Trauma, Multiple and Gun Shot Wound, run by University of Cape Town at 1 site in South Africa.

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 2 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 28 Apr 2021. 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 South Africa. 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?

Destination at discharge (time frame: 6 weeks after enrolment to study date). 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 28 Apr 2021.

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