Comparing treatments for preventing infection from frostbite injuries
Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
PHASE4 · University of Colorado, Denver · NCT06266494
This study is testing whether aloe vera and silver wound dressings can help prevent infections from frostbite injuries, while also looking at the safety of an antibiotic called Dalbavancin and how frostbite affects how the body processes medications.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | University of Colorado, Denver (other) |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT06266494 on ClinicalTrials.gov |
What this trial studies
This study compares the effectiveness of aloe vera and long-acting silver wound dressings in preventing infection from frostbite injuries. Additionally, it evaluates the safety and effectiveness of Dalbavancin, an FDA-approved antibiotic for treating frostbite wound infections. The study also aims to analyze how frostbite damage affects the clearance of drugs from the body, particularly focusing on kidney function. Participants will be adults aged 18 to 99 who are admitted to the UCH Burn Center with acute frostbite injuries or suspected infected frostbite wounds.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 99 who have been admitted to the UCH Burn Center with acute frostbite injuries or suspected infected frostbite wounds.
Not a fit: Patients who are pregnant, prisoners, or those with contraindications to the treatments being tested will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment protocols for preventing infections in frostbite patients, potentially reducing complications and enhancing recovery.
How similar studies have performed: While there is limited information on similar studies, the use of antimicrobial treatments in wound care has shown promise in other contexts, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Aurora, Colorado
- University of Colorado Denver Anschutz Medical Campus — Aurora, Colorado, United States (RECRUITING)
Study contacts
- Principal investigator: Arek Wiktor, MD — University of Colorado Anschtuz
- Study coordinator: Blaire Balstad
- Email: blaire.balstad@cuanschutz.edu
- Phone: 303-724-7803
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.
Conditions: Frostbite