NCT04480944

Brief Summary

Burns treatment and management has evolved since the 90s, particularly for massive burns (≥ 50% of total body surface area (TBSA)). This study aims at analyzing the impact of the management changes on the length of intensive care unit (ICU) stay, the take of skin grafts and the mortality.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 17, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 22, 2020

Completed
Last Updated

July 22, 2020

Status Verified

July 1, 2020

Enrollment Period

12 months

First QC Date

July 17, 2020

Last Update Submit

July 17, 2020

Conditions

Burns

Keywords

Massive burnsIntensive care unitBurn surgeryBurn infectionsSkin graftsCritical illnessCultured epithelial autograftsNutritionGlucose

Outcome Measures

Primary Outcomes (1)

  • LICU/Percent TBSA

    Ratio between the length of stay in the ICU and the total body surface area burned

    18 years

Secondary Outcomes (3)

  • Percent TBSA grafted/ Percent TBSA deep burns

    18 years

  • Daily nutritional intakes

    18 years

  • Mortality

    18 years

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adults patients with extremely large burns (massive burn \>50% TBSA) admitted and treated from beginning to end in the burn intensive care unit of a university hospital burn center in Switzerland

You may qualify if:

  • All adult patients (\>18 years old) with burns ≥50% TBSA admitted in the burn intensive care unit (ICU) of the Lausanne University Hospital

You may not qualify if:

  • Patients admitted in the burn center ICU with another primary diagnosis than burn (e.g. necrotizing fasciitis, gangrene, toxic epidermal necrolysis)
  • Patients referred from and/or to another ICU
  • Patients in which active withdrawal of care was decided within 48h of admission
  • Patients with first degree burns only

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adult ICU and Burn ICU, Lausanne University Hospital

Lausanne, Canton of Vaud, 1011, Switzerland

Location

Related Publications (2)

  • Pantet O, Stoecklin P, Vernay A, Berger MM. Impact of decreasing energy intakes in major burn patients: A 15-year retrospective cohort study. Clin Nutr. 2017 Jun;36(3):818-824. doi: 10.1016/j.clnu.2016.05.007. Epub 2016 May 24.

    PMID: 27256559BACKGROUND

  • Brusselaers N, Hoste EA, Monstrey S, Colpaert KE, De Waele JJ, Vandewoude KH, Blot SI. Outcome and changes over time in survival following severe burns from 1985 to 2004. Intensive Care Med. 2005 Dec;31(12):1648-53. doi: 10.1007/s00134-005-2819-6. Epub 2005 Oct 12.

    PMID: 16220315BACKGROUND

MeSH Terms

Conditions

BurnsCritical Illness

Condition Hierarchy (Ancestors)

Wounds and InjuriesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wassim Raffoul, MD

    CHUV

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate professor, MD, PhD

Study Record Dates

First Submitted

July 17, 2020

First Posted

July 22, 2020

Study Start

January 1, 2019

Primary Completion

December 31, 2019

Study Completion

March 31, 2020

Last Updated

July 22, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)