Timing of Surgery And Outcome in Burn Patients ( EARLYBURN )

Completed

• Conditions: Burns
• Interventions: Procedure: Late Excision of full thickness burn; Procedure: Early Excision of full thickness burn

• Registration Number: NCT02940171
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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

Study Timeline

• Study First Submitted: 2016-10-17
• Study First Submitted QC: 2016-10-19
• Study First Posted: 2016-10-20
• Study Start: 2016-12-25
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 470

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Late surgery	Late Excision of full thickness burn	Late Excision of full thickness burn First excision surgery of full -thickness burn performed after 48 hours from burn injury
Early surgery	Early Excision of full thickness burn	Early Excision of full thickness burn First excision surgery of full -thickness burn performed within 48 hours from burn injury

Primary Outcome Measures

Name	Time	Method
mortality	90 days

Secondary Outcome Measures

Name	Time	Method
One year mortality	One year	One year mortality
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	First 60 days	Nosocomial infections (numbers) during first 60 days
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 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

Trial Locations

Locations (1)

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