Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
Recruiting now · Phase 4
Conditions studied: Frostbite
In brief
This study will compare the effectiveness of two different treatments for preventing infection from frostbite injuries. These two treatments are A) aloe vera and B) long-acting silver wound dressings. The investigators will also study the safety and effectiveness of Dalbavancin, an FDA approved antibiotic used for treating people who develop frostbite wound infections, as well as evaluate how frostbite damage to individuals' bodies may affect how fast their kidney clear drugs from their systems.
Key facts
- Study ID
- NCT06266494
- Run by
- University of Colorado, Denver
- People needed
- 100
- Starts
- 2024-03-01
- Expected to finish
- 2026-08-01
- Last updated by the study team
- 2024-05-13
Who can join
Age: 18 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- All aims, aged ≥18 - < 99 years old admitted to UCH Burn Center with frostbite injury
- Aim 1: Admitted to UCH Burn Center with acute (within 4 days of cold exposure) frostbite injury
- Aim 2: Admitted to UCH Burn center with a clinically confirmed or suspected infected frostbite wound
You may not qualify if…
- Pregnant patients
- Prisoners
- Anticipated death within 48 hours of admission
- Inability to obtain consent from patient, legally authorized representative, or proxy
- Aim 1:Patients admitted five days and later from frostbite injury. Patients who have a clinical infection at baseline. Any patients that have a contra-indication for the use of either aloe (allergy), or silver (allergy).
- Aim 2: Any patients that have a contraindication for use of dalbavancin, including known history of hypersensitivity to dalbavancin, vancomycin, or other glycopeptide antibiotics. Patients with infections known to be caused by vancomycin-resistant Enterococcus; or those with Stage IV or V chronic kidney disease, or with cirrhosis (Childs-Pugh C); or those with anticipated death within 48 hours of infection.
- Aim 3: Anuria due to chronic kidney disease (CKD)
Where it is running
- University of Colorado Denver Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.