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BurnsMassiveBurnsNCT04480944

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

An observational study of Burns, run by Mette M Berger at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Burns
How many people
40 participants
Where
1 siteSwitzerland
Study dates
1 Jan 2019to 31 Mar 2020
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Adult ICU and Burn ICU, Lausanne University Hospital

    Lausanne, Canton of Vaud, 1011

Other trials in Switzerland

About this study

Official title: 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.

Read the 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

Conditions
Burns
Keywords
Massive burns, Intensive care unit, Burn surgery, Burn infections, Skin grafts, Critical illness, Cultured epithelial autografts, Nutrition, Glucose
Medical subject headings
Burns, Critical Illness

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LICU/Percent TBSA

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

    Measured: 18 years

Secondary outcomes (3)

  1. Percent TBSA grafted/ Percent TBSA deep burns

    Ratio between the TBSA grafted and the deep burns TBSA

    Measured: 18 years

  2. Daily nutritional intakes

    Daily energy, proteins, lipids and carbohydrates intakes per kilogram of body weight

    Measured: 18 years

  3. Mortality

    Percentage of patients who received maximal care and died nonetheless

    Measured: 18 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2020
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2019
  4. Study completion31 Mar 2020

Resources

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
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04480944
Sponsor's protocol ID
CER2018-02268
Acronym
MassiveBurns
Status last verified
Jul 2020
First submitted
17 Jul 2020
Last updated
22 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27256559

  • 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.

    PubMed 16220315

Questions about this trial

What is this clinical trial studying?

An observational study of Burns, run by Mette M Berger at 1 site in Switzerland.

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 4 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: finished, as of the sponsor's last update on 22 Jul 2020. 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 Switzerland. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LICU/Percent TBSA (time frame: 18 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04480944, which also lists 2 linked publications.

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 22 Jul 2020.

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