Timing of Surgery And Outcome in Burn Patients ( EARLYBURN )

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02940171

Acronym

EARLYBURN

Enrollment

470

Registered

2016-10-20

Start date

2016-12-25

Completion date

2023-12-11

Last updated

2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burns

Keywords

burns, critically ill, surgery outcome, mortality

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

Interventions

PROCEDUREEarly Excision of full thickness burn

first excision surgery of full -thickness burn performed within 48 hours from burn injury

PROCEDURELate Excision of full thickness burn

first excision surgery of full -thickness burn performed after 48 hours from burn injury

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
mortality	90 days

Secondary

Measure	Time frame	Description
Organ failure	28 and 60 days	—
Recovery from acute kidney	Until 28 and 60 days from burn injury	—
Median Sequential Organ Failure Assessment score (SOFA score) during first 28 days	First 28 days	Median Sequential Organ Failure Assessment score (SOFA score) during first 28
Nosocomial infections (numbers) during first 60 days	First 60 days	Nosocomial infections (numbers) during first 60 days
Nosocomial sepsis during first 60 days	First 60 days	Nosocomial sepsis during first 60 days
Length of stay in the ICU	One year	Length of stay in the ICU
analog scale of quality of life	One year	Functional sequel at one year, the patient will assesassess his overall quality of life since his accident Scale 1 to 10, with 1: poor, 10: good
One year mortality	One year	One year mortality

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMatthieu Dr Legrand, MD, PhD

Saint-Louis Hospital, Paris, France

PRINCIPAL_INVESTIGATORMourad BENYAMINA, MD, PH