## Protocol Section
### Identification Module
**NCT ID:** NCT04530279

**Brief Title:** Clinical Assessment of Burns in Norway

**Official Title:** Accordance of Clinical Assessment of Burn Depth and %TBSA Between Referring Hospitals and the National Norwegian Burn Centre

#### Organization Study ID Info
**ID:** 2014/1627, Rek-Vest
#### Organization
**Class:** OTHER
**Full Name:** Haukeland University Hospital
### Status Module
#### Completion Date
**Date:** 2023-06-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2022-03-21

**Type:** ACTUAL

**Last Update Submit Date:** 2022-03-18

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2018-01-01

**Type:** ACTUAL

**Status Verified Date:** 2022-03

#### Study First Post Date
**Date:** 2020-08-28
**Type:** ACTUAL
**Study First Submit Date:** 2020-08-25
**Study First Submit QC Date:** 2020-08-25
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Haukeland University Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Burns

**Keywords:**

- clinical assessment

- TBSA

- national burn centre

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Burn assessments performed in referring hospitals

**Intervention Names:**

- Procedure: Clinical assessment

**Label:** Referring hospital

#### Arm Group 2

**Description:** Burn assessments performed in the national burn centre

**Intervention Names:**

- Procedure: Clinical assessment

**Label:** Burn centre

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Burn centre

- Referring hospital

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

**Name:** Clinical assessment

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Burn depth

**Time Frame:** 1 year

**Description:** 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')

**Measure:** The percentage of total body surface area (TBSA) burnt

**Time Frame:** 1 year

### Eligibility Module

**Eligibility Criteria:** 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

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** ragnvald.ljones.brekke@helse-bergen.no

**Name:** Ragnvald L Brekke, MD

**Phone:** +4740874208

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bergen

**Contacts:**

***Contact 1:***

- **Email:** ragnvald.ljones.brekke@helse-bergen.no

- **Name:** Ragnvald L Brekke, MD

- **Phone:** +47 40874208

- **Role:** CONTACT

**Country:** Norway

**Facility:** Haukeland University Hospital

**State:** Vestland

**Status:** RECRUITING

**Zip:** 5021

#### Overall Officials

**Official 1:**

**Affiliation:** Haukeland University Hospital

**Name:** Ragnvald L Brekke, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M5326

- Name: Burns

- Relevance: HIGH

- As Found: Burn

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002056

- Term: Burns

### Misc Info Module

- Version Holder: 2024-05-24
