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Evaluation of Endothelial Glycocalyx in the Surgical Resuscitation of Major Burn Patients

Recruitingn/aAges 18 Years - anyAllHospital Universitari Vall d'Hebron Research Inst…
NCT06670248 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The purpose of this observational study is to examine whether Endotheliopathy of Trauma (EoT) is present in severely burned patients and how it is affected by burn debridement surgery. The main questions it aims to answer are: * Do severely burned patients present with EoT before undergoing burn debridement surgery? * Does the surgical intervention worsen EoT, leading to increased postoperative syndecan 1 (sdc 1) levels compared to preoperative levels? Participants will: * Undergo debridement surgery where the total area of debrided and donor sites covers 20% or more of the Total Body Surface Area (TBSA). * Have their sdc 1 levels measured before and after surgery. * Have perioperative factors analyzed to assess their impact on endothelial damage and glycocalyx functionality. This study aims to provide insight into how surgical resuscitation affects the endothelial glycocalyx in sev

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients over 18 years old with burned TBSA greater than or equal to 20%. * Patients who will undergo debridement of at least 20% of the burned TBSA (including the debrided area and the donor site). Exclusion Criteria: * Under 18 years old. * Pregnant women. * Patient refusal. * Polytraumatized patients. * Electrical or chemical burns. * Patients with any of the following pre-burn conditions: complicated heart disease\*, renal disease on hemodialysis/hemofiltration or with Glomerular Filtration Rate (GFR) \< 30 ml/min/1.73m², and liver cirrhosis (Child A, B, and C). (\* Definition of complicated heart disease: decompensated heart failure (NYHA class IV), Left Ventricular Ejection Fractio \< 40%, or severe valvular disease). * Patients with a history of chronic inflammatory diseases (autoimmune disease). * Patients on chronic treatment with corticosteroids or immunosuppressants. * Patients requiring reintervention for debridement surgery who have already been included in the study during their first surgery.
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What it tests

  • Debridement Surgery
  • Sdc-1 Level Measurement
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Where

1 site
Hospital Universitari Vall d'Hebron
Barcelona, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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