NCT01825343

Brief Summary

Purpose: a retrospective study of all Paediatric patients who presented to Ziv Medical Centre with injuries of all systems, major and minor, in order to determine the exact circumstances of the injury, whether this might have been preventable and design a Haddon Matrix of risk factors for injury to target prevention. Hypothesis: injury prevention interventions can be targetted by finding out local causes of Paediatric Trauma

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

April 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 5, 2013

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

April 5, 2013

Status Verified

April 1, 2013

Enrollment Period

1 year

First QC Date

April 2, 2013

Last Update Submit

April 4, 2013

Conditions

Keywords

fallburnroad traffic crash

Outcome Measures

Primary Outcomes (1)

  • Establishing exact mechanism of injury

    This is a retrospective study. We approximate that since the Trauma registry began in 2007, there have been 200 Paediatric injuries every year. By the end of this year's data collection, therefore, we estimate that we would have collected data from 1000 patients.

    5 years (2007-2012)

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Identify from the Trauma database all patients assessed at Ziv Medical Centre with Trauma, consult their medical notes and document the exact injury, the mechanism of injury, the circumstances, whether the child was alone or supervised, the nature and complications of the injury, treatment required and short and long term progress and disability.

You may qualify if:

  • All patients classified as Paediatric according to Israeli law (up to the age of 18 years). This includes pregnant women and patients presenting with multiple complaints as well as Trauma, isolated injuries and polytrauma.

You may not qualify if:

  • Patients for whom no history is available.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziv Hospital

Safed, Galilee, 13100, Israel

Location

Biospecimen

Retention: NONE RETAINED

We are looking retrospectively at data already stored on the hospital database. We have no human subjects and will only analyse hospital records. We will not be contacting patients.

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Wajdi Safadi, MD

    Specialist Surgeon

    STUDY CHAIR
  • Seema Biswas, FRCS

    Specialist Surgeon

    STUDY DIRECTOR
  • Amram Hadary, MD

    Senior Surgeon

    PRINCIPAL INVESTIGATOR
  • Igor Waksman, MD

    Head of Department

    STUDY CHAIR
  • Dudu Fuchs, RN

    Ziv Hospital Trauma Coordinator

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 5, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

April 5, 2013

Record last verified: 2013-04

Locations