Clinical trial NCT02940171: Timing of Surgery And Outcome in Burn Patients ( EARLYBURN )
Official title: Impact of Timing of Surgery on Outcome of Severely Ill Burn Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Burns
Keywords: burns
critically ill
surgery outcome
mortality
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2016-10-20
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with extensive skin burns, defined as greater than 20% of the total body surface

Brief summary: The prognostic 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 burn patients using a propensity analysis.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Admission to a burn unit within 72 hours from a burn injury
* Total burned surface area (TBSA)\>20%(2nd degree or 3rd degree) for any type of burn
* Patient covered by the social security
* Non-opposition to participate to the study and to the constitution of the biological collection

Exclusion Criteria:

* Decline to participate
* Decision not to resuscitate order before surgery
* Pregnant or breastfeeding patiente
* Decision to limit therapies in the first 24 hours
* Patient not resident in France
* Patient deprived of liberty

Primary outcomes:
measure: mortality
timeFrame: 90 days
Secondary outcomes:
measure: Organ failure
timeFrame: 28 and 60 days
measure: Recovery from acute kidney
timeFrame: Until 28 and 60 days from burn injury
measure: Median Sequential Organ Failure Assessment score (SOFA score) during first 28 days
timeFrame: First 28 days
measure: Nosocomial infections (numbers) during first 60 days
timeFrame: First 60 days
measure: Nosocomial sepsis during first 60 days
timeFrame: First 60 days
measure: Length of stay in the ICU
timeFrame: One year
measure: analog scale of quality of life
timeFrame: One year
measure: One year mortality
timeFrame: One year
Other outcomes:
Locations:
city: Paris
country: France
facility: Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital, University Paris Diderot
Study officials:
affiliation: Saint-Louis Hospital, Paris, France
name: Matthieu Dr Legrand, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint-Louis Hospital, Paris, France
name: Mourad BENYAMINA, MD, PH
role: PRINCIPAL_INVESTIGATOR
References: