- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04530279
Clinical Assessment of Burns in Norway
March 18, 2022 updated by: Haukeland University Hospital
Accordance of Clinical Assessment of Burn Depth and %TBSA Between Referring Hospitals and the National Norwegian Burn Centre
Clinical assessment of burn depth and area can be challenging even for experienced surgeons.
Still, the assessment is fundamental for the treatment, as it determines the fluid treatment and indication for escharotomy and need for referral to a burn centre.There are few studies comparing the initial evaluation of burn depth and surface with that of a specialist burn centre.
The aim of this study was to make such a comparison for a cohort of patients admitted to a specialist burn centre during one year.The cohort was defined as patients transferred to the burn unit at Haukeland university hospital during 2014.
Study Overview
Study Type
Observational
Enrollment (Anticipated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ragnvald L Brekke, MD
- Phone Number: +4740874208
- Email: ragnvald.ljones.brekke@helse-bergen.no
Study Locations
-
-
Vestland
-
Bergen, Vestland, Norway, 5021
- Recruiting
- Haukeland University Hospital
-
Contact:
- Ragnvald L Brekke, MD
- Phone Number: +47 40874208
- Email: ragnvald.ljones.brekke@helse-bergen.no
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The cohort was defined as patients transferred to the burn unit at Haukeland university hospital during 2014.The incidence of burns in Norway is 15.5 /100 000/ year (pop.
5.2 mill), and 70-100 patients a year is treated at the national burn centre. The
Australian and New Zealand Burn Association (ANZBA) referral criteria are used:
- Burns > 10% Total Body Surface Area (TBSA)
- Burns > 5% TBSA in children
- Full Thickness burns > 5% TBSA
- Burns of Special Areas - Face, Hands, Feet, Genitalia, Perineum, Major Joints and circumferential limb or chest burns
- Burns with inhalation injury
- Electrical burns
- Chemical burns
- Burns with pre-existing illness
- Burns associated with major trauma
- Burns at the extremes of age - young children and the elderly
- Burn injury in pregnant women
- Non-accidental burns
Description
Inclusion Criteria:
- Patients transferred to the burn unit at Haukeland university hospital during 2014
Exclusion Criteria:
- Readmissions
- Patients transported to Haukeland directly from the site of the accident
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Referring hospital
Burn assessments performed in referring hospitals
|
Clinical assessment of burn depth and the percentage of total body surface area (TBSA) burnt with any method
|
Burn centre
Burn assessments performed in the national burn centre
|
Clinical assessment of burn depth and the percentage of total body surface area (TBSA) burnt with any method
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Burn depth
Time Frame: 1 year
|
Burn depth measured with any described clinical method.Clinical assessment of depth is a subjective evaluation based on visual and tactile characteristics, that is, wound appearance, capillary refill and wound sensibility to touch and pin prick.
|
1 year
|
The percentage of total body surface area (TBSA) burnt
Time Frame: 1 year
|
TBSA measured with any described clinical method, for example, Wallace's Rule of Nines, Lund and Browder charts, and Palmar Surface Measurement ('rule of palm')
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ragnvald L Brekke, MD, Haukeland University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Anticipated)
December 31, 2022
Study Completion (Anticipated)
June 30, 2023
Study Registration Dates
First Submitted
August 25, 2020
First Submitted That Met QC Criteria
August 25, 2020
First Posted (Actual)
August 28, 2020
Study Record Updates
Last Update Posted (Actual)
March 21, 2022
Last Update Submitted That Met QC Criteria
March 18, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014/1627, Rek-Vest
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Burns
-
American Scitech InternationalJohnson & JohnsonUnknownBurns | Electric BurnsUnited States
-
MediWound LtdUnknownBurns, Upper Extremity | Burns, Lower ExtremitySlovakia
-
Singapore General HospitalUnknownAcute Thermal BurnsSingapore
-
RenovaCare, IncActive, not recruitingBurns | Burns Second Degree | Burns Deep Second DegreeUnited States
-
MediWound LtdCompletedThermal BurnsUnited States, Israel, Belgium, Czechia, Georgia, Germany, Italy, Romania
-
Sun Yat-sen UniversityCompleted
-
MediWound LtdActive, not recruitingThermal BurnsUnited States, United Kingdom, Spain, Georgia, Belgium, Poland, Germany, Hungary, India, Italy, Netherlands, Romania, Slovakia, Ukraine
-
Virginia Commonwealth UniversityNot yet recruiting
-
The Hong Kong Polytechnic UniversityCompleted
-
St. Justine's HospitalRecruiting
Clinical Trials on Clinical assessment
-
Thomas Jefferson UniversityCompletedHematopoietic and Lymphoid Cell Neoplasm | Malignant Solid NeoplasmUnited States
-
Florida International UniversityNational Institute of Mental Health (NIMH); University of MiamiCompletedDisruptive BehaviorUnited States
-
Fondazione Don Carlo Gnocchi OnlusCompletedChronic Low-back PainItaly
-
Czech Technical University in PragueMayo Clinic; University Hospital, Montpellier; McGill University Health Centre... and other collaboratorsUnknownParkinson Disease | REM Sleep Behavior DisorderUnited States, Canada, Austria, Czechia, France, Germany, Italy
-
Halic UniversityCompletedTemporomandibular Joint Dysfunction SyndromeTurkey
-
Assiut UniversityNot yet recruitingFeeding; Difficult, Newborn | Pre-Term
-
NHS Greater Glasgow and ClydeBiogenEnrolling by invitationRelapsing Remitting Multiple SclerosisUnited Kingdom
-
University Hospital, MontpellierUnknown
-
KU LeuvenUniversitaire Ziekenhuizen KU LeuvenRecruiting
-
University of Southern DenmarkCompletedAcute PyelonephritisDenmark