Surgery Timing In Outcome Burn Patients

Overview

Prognosis 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 patients using a propensity analysis.

Full Title of Study: “Impact of Timing of Surgery on Outcome of Severely Ill Burn Patients”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Prospective
• Study Primary Completion Date: March 25, 2021

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

Interventions

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

Arms, Groups and Cohorts

• Early surgery
  • Early Excision of full thickness burn 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

Clinical Trial Outcome Measures

Primary Measures

• mortality
  • Time Frame: 90 days

Secondary Measures

• 90 days free of organ failure
  • Time Frame: 90 days
• Fluid balance during 7 first days
  • Time Frame: 7 first days
• Acute kidney injury
  • Time Frame: until 28 days of hospitalization
• Median Sequential Organ Failure Assessment score (SOFA score) during first 28 days
  • Time Frame: First 28 days
• Nosocomial infections (numbers) during first 90 days
  • Time Frame: First 90 days
• Nosocomial sepsis during first 90 days
  • Time Frame: First 90 days
• Length of stay in the ICU
  • Time Frame: until 28 days of hospitalization
• analog scale of quality of life
  • Time Frame: One year
  • Functional sequel at one year The patient will asses his overall quality of life since his accident Scale 1 to 10, with 1: poor, 10: good
• One year mortality
  • Time Frame: One year

Participating in This Clinical Trial

Inclusion Criteria

• Age >18 years – Total burned surface area (TBSA)>20% – Non-opposition to participate Exclusion Criteria:

• Decline to participate – pregnancy – do-not resuscitate order

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Assistance Publique – Hôpitaux de Paris
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Matthieu Dr Legrand, MD, PhD, Principal Investigator, Saint-Louis Hospital, Paris, France
  • Mourad BENYAMINA, MD, PH, Principal Investigator, Saint-Louis Hospital, Paris, France
• Overall Contact(s)
  • Matthieu Dr Legrand, MD, PhD, 01 42 49 93 94, matthieu.m.legrand@gmail.com