NCT03854591

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 18, 2019

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

February 20, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 26, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

April 28, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

February 20, 2019

Last Update Submit

April 27, 2021

Conditions

Keywords

GLOBAL SURGERYCOLLABORATIVE RESEARCHGUNSHOT IN JURYEPIDEMIOLOGY

Outcome Measures

Primary Outcomes (1)

  • Destination at discharge

    Record of alive, dead or discharged

    6 weeks after enrolment to study date

Secondary Outcomes (5)

  • Number of cases

    18/02/2019-04/03/2019

  • Return to follow up

    01/04/2019-15/04/2019

  • Number of patients who give consent to additional study questions

    18/02/2019-04/03/2019

  • Health Related Quality of Life

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

  • Complications

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

Study Arms (1)

Gunshot related injury

Patients admitted to orthopaedic trauma service with gunshot related injury

Other: No intervention

Interventions

No intervention

Gunshot related injury

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groote Schuur Hospital

Cape Town, Western Cape, 7925, South Africa

Location

MeSH Terms

Conditions

Multiple TraumaWounds, Gunshot

Condition Hierarchy (Ancestors)

Wounds and InjuriesWounds, Penetrating

Study Officials

  • Simon Graham, FRCS

    Liverpool School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR
  • Sithombo Maqungo, FCS

    UCT

    PRINCIPAL INVESTIGATOR
  • Michael Held, FCS

    UCT

    PRINCIPAL INVESTIGATOR
  • Maritz Laubscher, FCS

    UCT

    PRINCIPAL INVESTIGATOR
  • James Masters, MRCS

    University of Oxford

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2019

First Posted

February 26, 2019

Study Start

February 18, 2019

Primary Completion

May 8, 2019

Study Completion

March 1, 2020

Last Updated

April 28, 2021

Record last verified: 2021-04

Locations