Actively Recruiting
Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
Led by University of Colorado, Denver · Updated on 2024-05-13
100
Participants Needed
1
Research Sites
126 weeks
Total Duration
On this page
Sponsors
U
University of Colorado, Denver
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to less than 99 years admitted to UCH Burn Center with frostbite injury
- For prevention: admitted within 4 days of cold exposure with acute frostbite injury
- For treatment: admitted with clinically confirmed or suspected infected frostbite wound
You will not qualify if you...
- Pregnant patients
- Prisoners
- Expected death within 48 hours of admission
- Unable to provide consent or have a representative provide consent
- For prevention: patients admitted 5 or more days after frostbite injury
- Patients with clinical infection at baseline for prevention aim
- Allergy to aloe vera or silver dressings
- For treatment: allergy to dalbavancin, vancomycin, or similar antibiotics
- Infections caused by vancomycin-resistant Enterococcus
- Stage IV or V chronic kidney disease or cirrhosis (Childs-Pugh C)
- Expected death within 48 hours of infection
- Anuria due to chronic kidney disease (CKD) for pharmacokinetic analysis aim
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively Recruiting
Research Team
B
Blaire Balstad
CONTACT
T
Tracey MacDermott
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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