Timing of Surgery And Outcome in Burn Patients ( EARLYBURN )

NCT02940171 | Terminated

• 1 other identifier: NI 14029
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Burns

Keywords

burns; critically ill; surgery outcome; mortality

Outcome Measures

Primary Outcomes (1)

• mortality

  90 days

Secondary Outcomes (8)

• 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

• Nosocomial infections (numbers) during first 60 days

  First 60 days

• Nosocomial sepsis during first 60 days

  First 60 days

Study Arms (2)

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

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

Interventions

Early Excision of full thickness burn PROCEDURE

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

Also known as: Early

Early surgery

Late Excision of full thickness burn PROCEDURE

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

Also known as: Late

Late surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, 75010, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and urine bank 1 / day of inclusion (D0): 1 sample (3 x 5 ml of blood). 1 sample (10 ml sample of urine) 2 / The seventh day of inclusion (D7): 1 sample (3 x 5 ml of blood) 1 sample (10 ml sample of urine) 3 / The twenty eighth day of inclusion (D28): 1 sample (3 x 5 ml of blood) 1 sample (10 ml sample of urine) 4 / The sixtieth day of inclusion (J60) or the day of the release from hospital: 1 sample (3 x 5 ml of blood) 1 sample (10 ml sample of urine) The aliquots will be stored locally at -20 °C or 80°C Every 6 months, they will be transported to the "Centre de Ressources Biologiques" (CRB) of the Lariboisière Hospital. The samples will be preserved for 10 years

MeSH Terms

Conditions

Burns; Critical Illness

Condition Hierarchy (Ancestors)

Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthieu Dr Legrand, MD, PhD

  Saint-Louis Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

• Mourad BENYAMINA, MD, PH

  Saint-Louis Hospital, Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2016
• First Posted: October 20, 2016
• Study Start: December 25, 2016
• Primary Completion: December 11, 2023
• Study Completion: December 11, 2023
• Last Updated: May 14, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)