No registrations found.
ID
Source
Brief title
Health condition
Fireworks-related injuries
Sponsors and support
Erasmus Medical Center, Medical Research Ethics Committee (MREC)
Intervention
Outcome measures
Primary outcome
Fireworks-related injury characteristics
Secondary outcome
- Number and type of operations
- Duration of hospital admission
- Direct medical and indirect societal costs
- Absence from school
- Quality of life (EuroQol-5D-3L; EQ-5D-3L)
- Health Utilities Index 3; HUI-3 (domains vision and dexterity)
- Visual acuity
- Quick Disabilities of Arm, Shoulder and Hand (Quick-DASH)
- Cold Intolerance Severity Scale (CISS)
- Lower Extremity Functional Scale (LEFS)
- Patient and Observer Scar Assessment Scale (POSAS)
- Patient satisfaction with their functional recovery and cosmesis
- How trauma has affected patient¡¯s view on the use of consumer fireworks
Background summary
BACKGROUND
Fireworks-related injuries frequently occur in both adults and children. It often entails serious and avoidable injuries to innocent bystanders. Most injuries are non-fatal but a substantial amount results in life-long disabilities affecting quality of life and the use of public health services. Currently, reliable data about the affected patients, their injury characteristics, the direct and indirect costs resulting from their injury and the loss of quality of life outcomes in the long-term is lacking.
AIM
The primary aim of this study is to determine the injury characteristics of fireworks-related injuries in patients reporting to a hospital for treatment.
The secondary aims are:
1) To determine the number and type of operations needed due to of fireworks-related injuries until one year after trauma
2) To determine the duration of hospital admission in these patients
3) To determine the direct medical costs and the indirect societal costs (incl. work
absence) in these patients
4) To investigate the absence from school in these patients
5) To investigate the patient-reported outcomes in these patients
- EuroQol-5D (EQ-5D-3L)
- Health Utility Index Mark 3 (domains for vision and dexterity) (HUI-3)
- Quick Disabilities of the Arm, Shoulder and Hand (Quick-DASH)
- Cold Intolerance Symptoms Severity (CISS)
- Lower Extremity Functional Scale (LEFS)
- Patient and Observer Scar Assessment Scale (POSAS)
- Patient satisfaction with the functional recovery and cosmesis
6) To investigate how the injury changed patient¡¯s view on the use of fireworks
STUDY DESIGN
Multicenter, prospective, observational study (case series)
POPULATION
All patients (no age limit) with fireworks-related injuries presenting to a hospital in the period between December 1, 2017 and January 31, 2018 in the Trauma Region
Southwest Netherlands.
INTERVENTION
Not applicable.
ENDPOINTS
Primary outcome measure: fireworks-related injury characteristics.
Secondary outcome measures: Number and type of operations; Duration of hospital admission; Direct medical and indirect societal costs; Absence from school; Quality of life (EuroQol-5D-3L; EQ-5D-3L); Health Utilities Index 3; HUI-3 (domains vision and dexterity); Visual acuity; Quick Disabilities of Arm, Shoulder and Hand (Quick-DASH); Cold Intolerance Severity Scale (CISS); Lower Extremity Functional Scale (LEFS); Patient and Observer Scar Assessment Scale (POSAS); Patient satisfaction with their functional recovery and cosmesis; How trauma has affected patient¡¯s view on the use of consumer fireworks.
RECRUITING COUNTRIES
The Netherlands.
Study objective
Fireworks-related injuries have a substantial impact on the medical costs, but a much larger impact on the societal costs.
Study design
2 weeks, 3 months, 6 months, and 12 months after hospital presentation.
Intervention
Not applicable
Mailbox H-822k 's-Gravendijkwal 230
3015 CE Rotterdam
E.M.M. van Lieshout
P.O. Box 2040
Rotterdam 3000 CA
The Netherlands
+31-10 7031050
e.vanlieshout@erasmusmc.nl
Mailbox H-822k 's-Gravendijkwal 230
3015 CE Rotterdam
E.M.M. van Lieshout
P.O. Box 2040
Rotterdam 3000 CA
The Netherlands
+31-10 7031050
e.vanlieshout@erasmusmc.nl
Inclusion criteria
1) Patients with any injury caused by fireworks treated* in a hospital in the Trauma Region Southwest Netherlands between December 1, 2017 and January 31, 2018
2) Provision of informed consent
* Treatment is defined as any intervention for which ¡Ý1 clinical follow-up visit is scheduled
Exclusion criteria
1) Patients who died within the first 24 hours due to other injuries than fireworks
2) Patients with incomplete or unknown contact information;
3) Insufficient understanding of Dutch or English to understand the study documents
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL6608 |
NTR-old | NTR6793 |
Other | METC Erasmus MC : MEC-2017-1066 (METC Erasmus MC) |
Summary results
[Firework injuries in the south-western region of the Netherlands around the turn of the year 2017-2018].
Ned Tijdschr Geneeskd. 2018 Nov 29;162