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Epidemiology, treatment (costs) and long-term outcomes of patients with fireworks-related injuries (ROCKET); a multicenter prospective observational case series


- candidate number28129
- NTR NumberNTR6793
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR31-okt-2017
- Secondary IDsMEC-2017-1066 (METC Erasmus MC) 
- Public TitleEpidemiology, treatment (costs) and long-term outcomes of patients with fireworks-related injuries (ROCKET); a multicenter prospective observational case series
- Scientific TitleEpidemiology, treatment (costs) and long-term outcomes of patients with fireworks-related injuries (ROCKET); a multicenter prospective observational case series
- ACRONYMROCKET
- hypothesisFireworks-related injuries have a substantial impact on the medical costs, but a much larger impact on the societal costs.
- Healt Condition(s) or Problem(s) studiedFireworks related injuries
- Inclusion criteria1) 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 ¡Ư1 clinical follow-up visit is scheduled
- Exclusion criteria1) 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
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-dec-2017
- planned closingdate31-aug-2019
- Target number of participants75
- InterventionsNot applicable
- Primary outcomeFireworks-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
- Timepoints2 weeks, 3 months, 6 months, and 12 months after hospital presentation.
- Trial web siteNone
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMSc PhD E.M.M. van Lieshout
- CONTACT for SCIENTIFIC QUERIESMD PhD M.H.J. Verhofstad
- Sponsor/Initiator Erasmus MC, Trauma Research Unit department of Surgery, Medical Research Ethics Committee (MREC) Erasmus MC
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsNone yet; study is ongoing
- Brief summaryBACKGROUND
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.
- Main changes (audit trail)
- RECORD31-okt-2017 - 19-nov-2017


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