Surgery Timing In Outcome Burn Patients

Study Overview
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Brief Summary
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Prognosis of burn patients has improved over the last decades. Early excision of full thickness burns is thought to be one of the key factors which have led to prognostic improvement. Best timing for burn excision remain uncertain however. In this multicenter observational study, we aim at exploring the impact of timing of surgery on outcome in severely ill patients using a propensity analysis.

Detailed Description
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The first aim of the study is to explore the impact of timing of the first surgery on outcome of severely ill burn patients. Because a randomization would not be feasible in this setting, we will use a propensity analysis in matching patients receiving early surgery and those receiving late surgery. Secondary aims are to evaluate the impact of the timing of surgery on morbidity (organs failure, infections, sepsis) but also to assess the diagnostic and prognostic value of plasma and urine biomarkers in severely ill burn patients

Official Title
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Impact of Timing of Surgery on Outcome of Severely Ill Burn Patients

Conditions
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Burns

Intervention / Treatment
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* Procedure: Early Excision of full thickness burn
* Procedure: Late Excision of full thickness burn


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Early surgery<br>Early Excision of full thickness burn First excision surgery of full -thickness burn performed within 48 hours from burn injury | Procedure: Early Excision of full thickness burn<br>* first excision surgery of full -thickness burn performed within 48 hours from burn injury<br>* Other names: Early;|
| Late surgery<br>Late Excision of full thickness burn First excision surgery of full -thickness burn performed after 48 hours from burn injury | Procedure: Late Excision of full thickness burn<br>* first excision surgery of full -thickness burn performed after 48 hours from burn injury<br>* Other names: Late;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90 days free of organ failure | 90 days free of organ failure | 90 days | 
| Fluid balance during 7 first days | Fluid balance during 7 first days | 7 first days | 
| Acute kidney injury | Acute kidney injury | until 28 days of hospitalization | 
| Median Sequential Organ Failure Assessment score (SOFA score) during first 28 days | Median Sequential Organ Failure Assessment score (SOFA score) during first 28 | First 28 days | 
| Nosocomial infections (numbers) during first 90 days | Nosocomial infections (numbers) during first 90 days | First 90 days | 
| Nosocomial sepsis during first 90 days | Nosocomial sepsis during first 90 days | First 90 days | 
| Length of stay in the ICU | Length of stay in the ICU | until 28 days of hospitalization | 
| analog scale of quality of life | Functional sequel at one year The patient will asses his overall quality of life since his accident Scale 1 to 10, with 1: poor, 10: good | One year | 
| One year mortality | One year mortality | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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burns, critically ill, surgery outcome, mortality