|- candidate number||27541|
|- NTR Number||NTR6565|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-jul-2017|
|- Secondary IDs||MEC-2017-357 |
|- Public Title||Epidemiology of injuries, treatment (costs), and outcome in burn patients admitted to a hospital with or without dedicated Burn Center (BURN-Pro); a multicenter prospective observational study
|- Scientific Title||Epidemiology of injuries, treatment (costs), and outcome in burn patients admitted to a hospital with or without dedicated Burn Center (BURN-Pro); a multicenter prospective observational study|
|- hypothesis||The majority of patients admitted outside a dedicated Burn Center will have a maximum of 10% Total Body Surface Area burned. |
|- Healt Condition(s) or Problem(s) studied||Burns|
|- Inclusion criteria||1) Patients with burn-related injuries, admitted to a hospital without dedicated Burn Center in the trauma regions South-West Netherlands or Brabant; |
Patients with <10% TBSA burned, who are primarily admitted or secondarily referred to the Burn Center of Maasstad Hospital
2) Provision of informed consent.
|- Exclusion criteria||1) Patients who died <24 hours due to severity of non-burn injuries;|
2) Patients with incomplete or unknown contact information;
3) Insufficient comprehension of the Dutch or English language to understand the questionnaires.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-aug-2017|
|- planned closingdate||1-aug-2020|
|- Target number of participants||300|
|- Interventions||Not applicable|
|- Primary outcome||Burn-related injury pattern|
|- Secondary outcome||- Compliance with Emergency Management of Severe Burns (EMSB) referral criteria|
- Treatment characteristics
- Treatment costs
- Health-Related Quality of life (EuroQol-5D-3L (EQ-5D))
- Patient and Observer Scar Assessment Scale (POSAS)
|- Timepoints||3 weeks, 6 weeks (optional), 3 months, 6 months, and 12 months after hospital admission.|
|- Trial web site||None.|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| C.H. van der Vlies|
|- CONTACT for SCIENTIFIC QUERIES||MD PhD M.H.J. Verhofstad|
|- Sponsor/Initiator ||Erasmus MC, Trauma Research Unit department of Surgery, Medical Research Ethics Committee (MREC) Erasmus MC|
(Source(s) of Monetary or Material Support)
|Nederlandse Brandwonden Stichting|
|- Publications||None yet; study is ongoing|
|- Brief summary||BACKGROUND|
Admission to a Burn Center is indicated for patients with severe burns or with specific characteristics like extreme age or comorbidities. The Emergency Management of Severe Burns (EMSB) referral criteria have been implemented for optimal triaging of burn patients. Extensive injury and outcome registration exists for patients admitted to a dedicated Burn Center, but limited information is available about the organization of care and referral of burn patients presented to a hospital elsewhere.
The primary aim of this study is to compare the burn injury characteristics of burn patients admitted to a hospital without dedicated Burn Center versus burn patients with <10% TBSA burned who are admitted (or secondarily referred) to a Burn Center.
The secondary aims are:
1. To determine if these admissions were in agreement with the EMSB referral criteria
2. To compare the treatment until one year after admission between these patient groups
3. To compare the treatment costs until one year after admission between these patient groups
4. To compare the Quality of Life (EQ-5D) between these patient groups at three, six, and 12 months follow-up.
5. To compare the scar quality (Patient and Observer Scar Assessment Scale (POSAS)) between these patient groups at three and 12 months follow-up.
Multicenter, prospective, observational study
All persons (no age limit) admitted with burn-related injuries to a hospital in the Southwest Netherlands or Brabant Trauma Region that do not have a dedicated Burn Center;
All patients (no age limit) with <10% TBSA burned who are primarily admitted or secondarily referred to the Burn Center of Maasstad Hospital.
Primary outcome measure: burn-related injury pattern.
Secondary outcome measures: Compliance with Emergency Management of Severe Burns (EMSB) referral criteria; Treatment characteristics; Treatment costs; Health-Related Quality of life (EuroQol-5D-3L (EQ-5D)); and Patient and Observer Scar Assessment Scale (POSAS).
|- Main changes (audit trail)|
|- RECORD||12-jul-2017 - 4-aug-2017|