Antimicrobial Treatments for Frostbite
(Frostbite Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have allergies to aloe, silver, or certain antibiotics like dalbavancin, you may not be eligible to participate.
What data supports the effectiveness of the drug Dalbavancin for treating frostbite?
Dalbavancin is effective against serious infections caused by Gram-positive bacteria, such as skin infections and bloodstream infections, and has been shown to reduce hospital stays. While it is not specifically studied for frostbite, its success in treating other severe infections suggests it might be beneficial.12345
Is Dalbavancin generally safe for human use?
How is the drug Dalbavancin unique in treating frostbite?
Dalbavancin is unique because it is a long-acting antibiotic that can be administered once weekly, which may reduce hospital stays. It is primarily used for serious skin infections and has shown effectiveness against hard-to-treat Gram-positive bacteria, making it a novel option for conditions like frostbite where standard treatments are not well-established.345910
Research Team
Arek Wiktor, MD
Principal Investigator
University of Colorado Anschtuz
Eligibility Criteria
This trial is for individuals with frostbite who are at risk of infection. Participants must have sustained frostbite recently and be in a condition where they can receive the treatments being tested. Specific criteria about who can or cannot participate, such as age range, severity of frostbite, or other health conditions that might affect their participation, were not provided.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Aloe Vera applied twice daily or Long-Acting Silver Dressings applied every 4 days to frostbitten tissues. Additionally, participants may receive a single 1500mg dose of Dalbavancin intravenously.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including Dalbavancin concentration measurements and renal clearance evaluations.
Treatment Details
Interventions
- Dalbavancin
Dalbavancin is already approved in United States for the following indications:
- Acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible strains of Gram-positive microorganisms
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Congressionally Directed Medical Research Programs
Collaborator