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

NCT ID: NCT03854591

Last Updated: 2021-04-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 138 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-18
• Study Completion Date: 2020-03-01

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.

Conditions

Trauma, Multiple; Gun Shot Wound

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Gunshot related injury

Patients admitted to orthopaedic trauma service with gunshot related injury

No intervention

Intervention Type: OTHER

No intervention

Interventions

No intervention

No intervention

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oxford

OTHER

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: lead

Responsible Party

Dr Maritz Laubscher

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Graham, FRCS

Role: PRINCIPAL_INVESTIGATOR

Liverpool School of Hygiene and Tropical Medicine

Sithombo Maqungo, FCS

Role: PRINCIPAL_INVESTIGATOR

UCT

Michael Held, FCS

Role: PRINCIPAL_INVESTIGATOR

UCT

Maritz Laubscher, FCS

Role: PRINCIPAL_INVESTIGATOR

UCT

James Masters, MRCS

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Locations

Groote Schuur Hospital

Cape Town, Western Cape, South Africa

Countries

South Africa

Other Identifiers

755/2018

Identifier Type: -

Identifier Source: org_study_id