BurnsNCT04530279
Clinical Assessment of Burns in Norway
An observational study of Burns, run by Haukeland University Hospital at 1 site in Norway.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Burns
- What is being tested?
- Clinical assessment
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2018to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- Patients transferred to the burn unit at Haukeland university hospital during 2014
Who cannot join
- Readmissions
- Patients transported to Haukeland directly from the site of the accident
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Haukeland University Hospital
Bergen, Vestland, 5021
Ragnvald L Brekke, MD, +47 40874208, ragnvald.ljones.brekke@helse-bergen.no
About this study
Official title: 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.
- Conditions
- Burns
- Being tested
- Clinical assessment
- Keywords
- clinical assessment, TBSA, national burn centre
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical assessmentProcedure or surgery
Clinical assessment of burn depth and the percentage of total body surface area (TBSA) burnt with any method
| Study group | Role | What they receive |
|---|---|---|
| Referring hospital | Burn assessments performed in referring hospitals Receives: Procedure: Clinical assessment | |
| Burn centre | Burn assessments performed in the national burn centre Receives: Procedure: Clinical assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Burn depth
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.
Measured: 1 year
The percentage of total body surface area (TBSA) burnt
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')
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies of the same condition, open and under way.
- More trials run by Haukeland University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Haukeland University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ragnvald L Brekke, MD, Principal investigator, Haukeland University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04530279
- Sponsor's protocol ID
- 2014/1627, Rek-Vest
- Status last verified
- Mar 2022
- First submitted
- 25 Aug 2020
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accordance of Clinical Assessment of Burn Depth and %TBSA Between Referring Hospitals and the National Norwegian Burn Centre
- ClinicalTrials.gov ID
- NCT04530279
- Acronym / sponsor ID
- 2014/1627, Rek-Vest
- Conditions
- Burns
- Keywords
- clinical assessment, TBSA, national burn centre
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Haukeland University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 28 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Referring hospital | – | Procedure: Clinical assessmentBurn assessments performed in referring hospitals |
| Burn centre | – | Procedure: Clinical assessmentBurn assessments performed in the national burn centre |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients transferred to the burn unit at Haukeland university hospital during 2014
Key exclusion criteria (2 listed)
- Readmissions
- Patients transported to Haukeland directly from the site of the accident
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical assessmentClinical assessment of burn depth and the percentage of total body surface area (TBSA) burnt with any method | Procedure or surgery | Burn centre, Referring hospital |
Primary outcome
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.
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')
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ragnvald L Brekke, MD principal investigator
Haukeland University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Burns, run by Haukeland University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ragnvald L Brekke, MD (+4740874208, ragnvald.ljones.brekke@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Burn depth (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.