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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 March 2024 |
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Main ID: |
NCT02940171 |
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Date of registration:
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17/10/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Surgery Timing In Outcome Burn Patients
EARLYBURN |
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Scientific title:
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Impact of Timing of Surgery on Outcome of Severely Ill Burn Patients |
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Date of first enrolment:
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December 25, 2016 |
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Target sample size:
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470 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/ct2/show/NCT02940171 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Contacts
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Name:
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Mourad BENYAMINA, MD, PH |
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Address:
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Telephone:
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Email:
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Affiliation:
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Saint-Louis Hospital, Paris, France |
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Name:
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Matthieu Dr Legrand, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Saint-Louis Hospital, Paris, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age >18 years
- Total burned surface area (TBSA)>20%
- Non-opposition to participate
Exclusion Criteria:
- Decline to participate
- pregnancy
- do-not resuscitate order
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Burns
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Intervention(s)
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Procedure: Late Excision of full thickness burn
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Procedure: Early Excision of full thickness burn
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Primary Outcome(s)
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mortality
[Time Frame: 90 days]
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Secondary Outcome(s)
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90 days free of organ failure
[Time Frame: 90 days]
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Nosocomial infections (numbers) during first 90 days
[Time Frame: First 90 days]
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Acute kidney injury
[Time Frame: until 28 days of hospitalization]
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Nosocomial sepsis during first 90 days
[Time Frame: First 90 days]
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Fluid balance during 7 first days
[Time Frame: 7 first days]
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Median Sequential Organ Failure Assessment score (SOFA score) during first 28 days
[Time Frame: First 28 days]
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analog scale of quality of life
[Time Frame: One year]
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Length of stay in the ICU
[Time Frame: until 28 days of hospitalization]
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One year mortality
[Time Frame: One year]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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