Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03854591 |
| Other study ID # |
755/2018 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
February 18, 2019 |
| Est. completion date |
March 1, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
University of Cape Town |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
