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Timing of Surgery And Outcome in Burn Patients ( EARLYBURN )

A

Assistance Publique - Hôpitaux de Paris

Status

Completed

Conditions

Burns

Treatments

Procedure: Late Excision of full thickness burn
Procedure: Early Excision of full thickness burn

Study type

Observational

Funder types

Other

Identifiers

NCT02940171
NI 14029

Details and patient eligibility

About

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.

Full 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

Enrollment

470 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

470 participants in 2 patient groups

Early surgery
Description:
Early Excision of full thickness burn First excision surgery of full -thickness burn performed within 48 hours from burn injury
Treatment:
Procedure: Early Excision of full thickness burn
Late surgery
Description:
Late Excision of full thickness burn First excision surgery of full -thickness burn performed after 48 hours from burn injury
Treatment:
Procedure: Late Excision of full thickness burn

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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