Timing of Surgery And Outcome in Burn Patients ( EARLYBURN )

Burns Clinical Trial

— EARLYBURN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02940171
• Other study ID #: NI 14029
• Status: Completed
• Start date: December 25, 2016
• Est. completion date: December 11, 2023

Study information

• Verified date: April 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: December 11, 2023
• Est. primary completion date: December 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns

Intervention

Procedure:
• Early Excision of full thickness burn
first excision surgery of full -thickness burn performed within 48 hours from burn injury
• Late Excision of full thickness burn
first excision surgery of full -thickness burn performed after 48 hours from burn injury

Locations

Country	Name	City	State
France	Departement of Anesthesiology, Critical Care and Burn Unit; Saint-Louis hospital, University Paris Diderot	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality		90 days
Secondary	Organ failure		28 and 60 days
Secondary	Recovery from acute kidney		Until 28 and 60 days from burn injury
Secondary	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
Secondary	Nosocomial infections (numbers) during first 60 days	Nosocomial infections (numbers) during first 60 days	First 60 days
Secondary	Nosocomial sepsis during first 60 days	Nosocomial sepsis during first 60 days	First 60 days
Secondary	Length of stay in the ICU	Length of stay in the ICU	One year
Secondary	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
Secondary	One year mortality	One year mortality	One year