Timing of Surgery And Outcome in Burn Patients ( EARLYBURN )

NCT ID: NCT02940171

Last Updated: 2024-07-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 470 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-25
• Study Completion Date: 2023-12-11

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

Conditions

Burns

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Early surgery

Early Excision of full thickness burn First excision surgery of full -thickness burn performed within 48 hours from burn injury

Early Excision of full thickness burn

Intervention Type: PROCEDURE

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

Late surgery

Late Excision of full thickness burn First excision surgery of full -thickness burn performed after 48 hours from burn injury

Late Excision of full thickness burn

Intervention Type: PROCEDURE

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

Interventions

Early Excision of full thickness burn

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

Intervention Type: PROCEDURE

Late Excision of full thickness burn

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

Intervention Type: PROCEDURE

Other Intervention Names

Early; Late

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Matthieu Dr Legrand, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Saint-Louis Hospital, Paris, France

Mourad BENYAMINA, MD, PH

Role: PRINCIPAL_INVESTIGATOR

Saint-Louis Hospital, Paris, France

Locations

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

Paris, , France

Countries

France

Other Identifiers

NI 14029

Identifier Type: -

Identifier Source: org_study_id