Evaluating the impact of surgery on blood vessel health in severe burn patients
GlycoBURN Study: Determination of Endothelial Glycocalyx Status in the Surgical Resuscitation of Severe Burn Patients
This study tests how burn surgery affects blood vessel health in patients with severe burns to see if it helps them heal better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute Academic / other |
| Locations | 1 site (Barcelona, Spain) |
| Trial ID | NCT06670248 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the presence of Endotheliopathy of Trauma (EoT) in severely burned patients and how it is influenced by burn debridement surgery. Participants will undergo surgery to remove damaged skin, covering at least 20% of their total body surface area, while their syndecan 1 levels will be measured before and after the procedure. The study aims to analyze perioperative factors that may affect endothelial damage and the functionality of the glycocalyx, a protective layer of blood vessels. Insights gained could help improve surgical outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with severe burns covering 20% or more of their total body surface area who are scheduled for debridement surgery.
Not a fit: Patients under 18, pregnant women, or those with certain pre-existing conditions such as complicated heart disease or chronic inflammatory diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for surgical resuscitation in severely burned patients, potentially reducing complications and improving recovery.
How similar studies have performed: While the specific approach of this study is novel, previous research has indicated that early burn debridement can improve outcomes in severely burned patients.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Barcelona, Spain
- Hospital Universitari Vall d'Hebron — Barcelona, Spain, Spain (Recruiting)
Study contacts
- Study coordinator: Laura Pons Pellicé, MD
- Email: laura.pons@vallhebron.cat
- Phone: +34 626498575
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.