Penetrating Gunshot Injuries at a Single Johannesburg Centre | NCT05016986

Studies
Penetrating Gunshot Injuries at a Single Johannesburg Centre

NCT05016986

Sponsor

University of Witwatersrand, South Africa

Status

Completed

Last Update Posted

Aug 23, 2021Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Trauma

Interventions

Standard clinical management

Countries

South Africa

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2008Actual

Primary Completion Date

Dec 31, 2018Actual

Completion Date

Jun 30, 2019Actual

First Submitted Date

Aug 16, 2021

First Submission Date that Met QC Criteria

Aug 20, 2021

First Posted Date

Aug 23, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2021

Last Update Posted Date

Aug 23, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maeyane Stephens Moeng, Prof, University of Witwatersrand, South AfricaPrincipal Investigator

Lead Sponsor

University of Witwatersrand, South AfricaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A retrospective audit of cardiac penetrating cardiac injuries with specific reference to GSW

Detailed Description

A descriptive retrospective study looking at the outcomes in patients with penetrating cardiac injuries especially following gunshot injuries. The physiology on presentation, the ISS, the RTS, the clinical injuries confirmed, the type of investigations conducted, the length of hospital stay, the in-hospital mortality will all be collected. Descriptive study statistics will be utilized and a p-value of <0,05 will be considered statistically significant.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standard clinical management	Other	outcomes in GSW cardiac injuries

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Injury patterns (check list)	Document cardiac injuries noted in the study group	01 Jan 2008 till 31 December 2018
The number of in-hospital patients who survive the injury		01 jan 2008 till 31 December 2018

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all adult Priority 1 patients with GSW cardiac injuries seen at a Johannesburg Trauma facility

Exclusion Criteria:

Incomplete data or dead on arrival

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Trauma patients who sustained GSW to chest with cardiac injuries in a sigle centre

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Maeyane Moeng, MBBCH, FCS	University of Witwatersrand, South Africa	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charlotte Maxeke Johanneburg Academic Hospital		Johannesburg	Gauteng	2193	South Africa
Charlotte Maxeke Johanneburg Academic Hospital

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D014947	Wounds and Injuries

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided