Massive Burns: Retrospective Analysis of Changes in Outcomes Across 18 Years (MassiveBurns)

July 17, 2020 updated by: Mette M Berger

Massive Burns: Retrospective Analysis of Change in Outcomes Across 18 Years

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.

Study Overview

Status

Completed

Conditions

Detailed Description

Review of all massively burned patients treated at Lausanne University Hospital burn intensive care unit (ca. 40-60 patients). Analysis of changes in length of intensive care unit stay (LICU), skin graft take rate or mortality between 2000 and 2018.

Hypothesis : the optimization of resuscitation procedures and of nutrition therapy combined with the use of novel surgical techniques has brought a significant improvement in outcomes.

Association between outcomes and year of admission will be assessed through correlation analysis and logistic regression analysis. Potential cofounders will be assessed through stepwise linear regression analysis

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • Vaud
      • Lausanne, Vaud, Switzerland, 1011
        • Adult ICU and Burn ICU, Lausanne University Hospital

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
LICU/Percent TBSA
Time Frame: 18 years
Ratio between the length of stay in the ICU and the total body surface area burned
18 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent TBSA grafted/ Percent TBSA deep burns
Time Frame: 18 years
Ratio between the TBSA grafted and the deep burns TBSA
18 years
Daily nutritional intakes
Time Frame: 18 years
Daily energy, proteins, lipids and carbohydrates intakes per kilogram of body weight
18 years
Mortality
Time Frame: 18 years
Percentage of patients who received maximal care and died nonetheless
18 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mette M Berger

Investigators

  • Study Director: Wassim Raffoul, MD, CHUV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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, 2019

Primary Completion (ACTUAL)

December 31, 2019

Study Completion (ACTUAL)

March 31, 2020

Study Registration Dates

First Submitted

July 17, 2020

First Submitted That Met QC Criteria

July 17, 2020

First Posted (ACTUAL)

July 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 22, 2020

Last Update Submitted That Met QC Criteria

July 17, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER2018-02268

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

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.

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