Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Launched by UNIVERSITY OF COLORADO, DENVER · Feb 15, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at how to prevent and treat infections that can occur from frostbite injuries. Researchers are comparing two treatments: aloe vera and long-acting silver wound dressings, to see which one is more effective in stopping infections. They will also examine the safety of an antibiotic called Dalbavancin, which is already approved for treating infections, and how frostbite might affect how quickly a person's kidneys can process medications.

To participate in the study, you need to be at least 18 years old and have been admitted to the UCH Burn Center with a frostbite injury within four days of exposure to cold. However, there are some exclusions, such as being pregnant or having certain medical conditions. If you join the trial, you can expect to receive one of the treatments being tested and to be monitored for your health and safety throughout the process. This study aims to find the best ways to manage frostbite injuries and improve care for patients like you.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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
• Exclusion Criteria:
• • 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)