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.
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.
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.
- Conditions
- Trauma, Multiple, Gun Shot Wound
- 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 group | Role | What they receive |
|---|---|---|
| Gunshot related injury | Patients 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.
Destination at discharge
Record of alive, dead or discharged
Measured: 6 weeks after enrolment to study date
Secondary outcomes (5)
Number of cases
Total number of gunshot related injuries admitted at each unit
Measured: 18/02/2019-04/03/2019
Return to follow up
Number of patients that attend their routine follow up appointment
Measured: 01/04/2019-15/04/2019
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
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
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.
- First posted26 Feb 2019
- Study start18 Feb 2019
- Primary completion8 May 2019
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma, MultipleStudies 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
- Prospective
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cape Town
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oxford
- Responsible party
- Principal investigator, Dr Maritz Laubscher, University of Cape Town
- Investigators
- Simon Graham, FRCS, Principal investigator, Liverpool School of Hygiene and Tropical MedicineSithombo Maqungo, FCS, Principal investigator, UCTMichael Held, FCS, Principal investigator, UCTMaritz Laubscher, FCS, Principal investigator, UCTJames Masters, MRCS, Principal investigator, University of Oxford
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gunshot Related Injuries in Trauma
- ClinicalTrials.gov ID
- NCT03854591
- Acronym / sponsor ID
- GRIT / 755/2018
- Conditions
- Trauma, Multiple, Gun Shot Wound
- Keywords
- GLOBAL SURGERY, COLLABORATIVE RESEARCH, GUNSHOT IN JURY, EPIDEMIOLOGY
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- University of Cape TownUniversity, hospital or other
- Collaborators
- University of Oxford
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 8 May 2019 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 26 Feb 2019 (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.
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.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gunshot related injury | – | Other: No interventionPatients admitted to orthopaedic trauma service with gunshot related injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Any adult patient presenting with at least one gunshot injury to the limb, spine or pelvis
Key inclusion criteria (1 listed)
- Any gunshot related injury presenting to registered study hospital's orthopaedic service.
Key exclusion criteria (2 listed)
- Isolated injuries to the head, chest or abdomen
- Patients under 18 years of age
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 |
|---|---|---|
| No interventionNo intervention | Other | Gunshot related injury |
Primary outcome
Destination at discharge
Time frame: 6 weeks after enrolment to study date
Record of alive, dead or discharged
5 secondary outcomes
Number of cases
Time frame: 18/02/2019-04/03/2019
Return to follow up
Time frame: 01/04/2019-15/04/2019
Number of patients who give consent to additional study questions
Time frame: 18/02/2019-04/03/2019
Health Related Quality of Life
Time frame: Total study period 18/02/2019-15/04/2019
Complications
Time frame: Total study period 18/02/2019-15/04/2019
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 28 Apr 2021.
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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.
Simon Graham, FRCS principal investigator
Liverpool School of Hygiene and Tropical Medicine
Sithombo Maqungo, FCS principal investigator
UCT
Michael Held, FCS principal investigator
UCT
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 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.