search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Burden of burn injuries: quantifying the societal impact of burns with a state-of-art burden of disease methodology


- candidate number26710
- NTR NumberNTR6407
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR16-feb-2017
- Secondary IDsNL59981 
- Public TitleBurden of burn injuries: quantifying the societal impact of burns with a state-of-art burden of disease methodology
- Scientific TitleBurden of burn injuries: quantifying the societal impact of burns with a state-of-art burden of disease methodology
- ACRONYMBOD study
- hypothesisAn observational study to obtain a comprehensive overview of long-term (≥5 years after burn injury) consequences after burn injuries, both in all patients admitted to burn centre admissions and in a subgroup of patients who suffered from more extensive burns.
- Healt Condition(s) or Problem(s) studiedBurns
- Inclusion criteria- Patients of all ages with a hospital stay of ≥1 night or with surgical treatment for their burns in the period August 2011 – July 2012
- Informed consent
For the extended cohort on severe burns:
- Patients (≥10 - ≤50 years old) with major burns (over 20% TBSA)
- Patients (<10 and >50 years old) with major burns (over 10% TBSA)
- Patients with TBSA third degree > 5%
- Exclusion criteriaInsufficient knowledge of the Dutch language
Deceased
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-mrt-2017
- planned closingdate1-mrt-2019
- Target number of participants448
- InterventionsNone
- Primary outcomeLong-term generic HRQL of children and adult burn survivors will be assessed by the ‘EuroQol-5D-5L + cognitive domain’ (EQ-5D-5L).
- Secondary outcomeThe secondary outcome parameters of this study are long-term burn specific HRQL, long-term functions, activities and participation of burn survivors:
 Burn specific HRQL
o Score on the Burns Specific Health Scale-brief (BSHS-B) in adults
o Score on the Burn Outcome Questionnaire (BOQ) in children aged 5 – 18 years
 Scar quality
o Score on the Patient and Observer Scar Assessment Scale (POSAS) patient score
 Itching of scar
o Score on the POSAS patient score
 Depressive symptoms
o Score on the Beck Depression Inventory (BDI-II-NL)
 Perceived stigmatization
o Score on the Perceived Stigmatization Questionnaire (PSQ) in adults
 Participation
o Score on the Work Productivity and Activity Impairment General Health (WPAI-GH)
Additional parameters, only for the cohort on extensive burns:
 Scar quality
o Score on the POSAS observer score
 Contractures
o Reconstructive surgery
 Muscular strength
o Grip strength (Force in Newton) measured by a Hand-Held Dynamometer
 Aerobic capacity
o Maximum achieved wattage during the Steep Ramp Test (SRT)
 Habitual physical activity patterns
o Score on the Habitual Physical Activity Questionnaire (PAQ)
 Fatigue
o Score on the Brief Fatigue Inventory (BFI)
 Body composition
o Body mass index (BMI) and waist circumference
- TimepointsOutcomes will assessed once. At least 5 years after burns.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Inge Spronk
- CONTACT for SCIENTIFIC QUERIES Inge Spronk
- Sponsor/Initiator Association of Dutch Burn Centres
- Funding
(Source(s) of Monetary or Material Support)
Dutch Burns Foundation (Nederlandse Brandwonden Stichting)
- Publications
- Brief summarySUMMARY
Rationale: Burden of disease calculations are an important resource in public health. The burden of disease aggregates all health consequences of a disease in one metric and is increasingly used for priority setting in health care, surveillance and interventions. For the calculation of the burden of disease, information on long-term consequences of the specific disease is needed. Currently, little is known about the long-term consequences and secondary conditions after burns. Therefore, calculation of the burden of burns is challenging.
Objective: To obtain a comprehensive overview of long-term (≥5 years after burn injury) consequences after burn injuries, both in all patients admitted to burn centre admissions and in a subgroup of patients who suffered from more extensive burns.
Study design: A multicentre cross-sectional study.
Study population: All burn patients (children and adults) who have been admitted to one of the three Dutch burn centres in the period August 2011 – July 2013 and with a hospital stay of more than one day or who have had surgical treatment for their burns.
For the cohort on extensive burns: all patients with extensive burns (over 20% total body surface area (TBSA)) in adults, over 10% TBSA in children <10 years or adults >50 years or TBSA third degree > 5% who had an admission to one of the three Dutch burn centres in the period 2010 – 2013.
Intervention (if applicable): Not applicable
Main study parameters/endpoints: To assess long-term health-related quality of life and long-term functioning, activities and participation of burn survivors, questionnaires that include questions on health-related quality of life, on body functioning, on participation and on environmental factors will be assessed in all patients.
In addition, to fully elucidate long-term consequences of extensive burns, muscular strength, aerobic capacity, contractures, body composition, fatigue, and habitual physical activity will be assessed in patients with extensive burns.
- Main changes (audit trail)
- RECORD16-feb-2017 - 23-jun-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl