NCT04530279

Brief 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 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

5 years

First QC Date

August 25, 2020

Last Update Submit

March 18, 2022

Conditions

Keywords

clinical assessmentTBSAnational burn centre

Outcome Measures

Primary Outcomes (2)

  • 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.

    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')

    1 year

Study Arms (2)

Referring hospital

Burn assessments performed in referring hospitals

Procedure: Clinical assessment

Burn centre

Burn assessments performed in the national burn centre

Procedure: Clinical assessment

Interventions

Clinical assessment of burn depth and the percentage of total body surface area (TBSA) burnt with any method

Burn centreReferring hospital

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patients transferred to the burn unit at Haukeland university hospital during 2014

You may not qualify if:

  • Readmissions
  • Patients transported to Haukeland directly from the site of the accident

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haukeland University Hospital

Bergen, Vestland, 5021, Norway

RECRUITING

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Ragnvald L Brekke, MD

    Haukeland University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 28, 2020

Study Start

January 1, 2018

Primary Completion

December 31, 2022

Study Completion

June 30, 2023

Last Updated

March 21, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations