Clinical trial NCT03854591: A Snapshot Study of Patients Affected by Gunshot Related Injuries in Trauma in South Africa
Official title: Gunshot Related Injuries in Trauma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma, Multiple
Gun Shot Wound
Keywords: GLOBAL SURGERY
COLLABORATIVE RESEARCH
GUNSHOT IN JURY
EPIDEMIOLOGY
Lead sponsor: University of Cape Town
Sponsor class: OTHER
Collaborators: name: University of Oxford
First posted: 2019-02-26
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any adult patient presenting with at least one gunshot injury to the limb, spine or pelvis

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Destination at discharge
timeFrame: 6 weeks after enrolment to study date
Secondary outcomes:
measure: Number of cases
timeFrame: 18/02/2019-04/03/2019
measure: Return to follow up
timeFrame: 01/04/2019-15/04/2019
measure: Number of patients who give consent to additional study questions
timeFrame: 18/02/2019-04/03/2019
measure: Health Related Quality of Life
timeFrame: Total study period 18/02/2019-15/04/2019
measure: Complications
timeFrame: Total study period 18/02/2019-15/04/2019
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Groote Schuur Hospital
state: Western Cape
Study officials:
affiliation: Liverpool School of Hygiene and Tropical Medicine
name: Simon Graham, FRCS
role: PRINCIPAL_INVESTIGATOR
affiliation: UCT
name: Sithombo Maqungo, FCS
role: PRINCIPAL_INVESTIGATOR
affiliation: UCT
name: Michael Held, FCS
role: PRINCIPAL_INVESTIGATOR
affiliation: UCT
name: Maritz Laubscher, FCS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: James Masters, MRCS
role: PRINCIPAL_INVESTIGATOR
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