Timing of Surgery And Outcome in Burn Patients ( EARLYBURN ) (EARLYBURN)

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

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.

Study Overview

• Status: Terminated
• Conditions: Burns
• Intervention / Treatment: Procedure: Early Excision of full thickness burn; Procedure: Late Excision of full thickness burn

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

• Study Type: Observational
• Enrollment (Actual): 470

Contacts and Locations

Study Locations

• France
  • Paris, France, 75010
    • Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital, University Paris Diderot

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients with extensive skin burns, defined as greater than 20% of the total body surface

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Early surgery; 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; first excision surgery of full -thickness burn performed within 48 hours from burn injury; Other Names: Early
Late surgery; 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; first excision surgery of full -thickness burn performed after 48 hours from burn injury; Other Names: Late

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
mortality	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
One year mortality	One year mortality	One year
Organ failure		28 and 60 days
Recovery from acute kidney		Until 28 and 60 days from burn injury
Nosocomial infections (numbers) during first 60 days	Nosocomial infections (numbers) during first 60 days	First 60 days
Nosocomial sepsis during first 60 days	Nosocomial sepsis during first 60 days	First 60 days
Length of stay in the ICU	Length of stay in the ICU	One year
analog scale of quality of life	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Matthieu Dr Legrand, MD, PhD, Saint-Louis Hospital, Paris, France; Principal Investigator: Mourad BENYAMINA, MD, PH, Saint-Louis Hospital, Paris, France

Study record dates

Study Major Dates

• Study Start (Actual): December 25, 2016
• Primary Completion (Actual): December 11, 2023
• Study Completion (Actual): December 11, 2023

Study Registration Dates

• First Submitted: October 17, 2016
• First Submitted That Met QC Criteria: October 19, 2016
• First Posted (Estimated): October 20, 2016

Study Record Updates

• Last Update Posted (Actual): May 14, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: critically ill; burns; surgery outcome; mortality
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Disease Attributes; Pathological Conditions, Signs and Symptoms; Critical Illness; Burns
• Other Study ID Numbers: NI 14029

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No