RecruitingPhase 4

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

United States100 participantsStarted 2024-03-01

Plain-language summary

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.

Who can participate

Age range

18 Years – 99 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The number of positive microbial wound cultures on admission

Timeframe: Admission

The number of positive microbial wound cultures on hospital day 4

Timeframe: Hospital Day 4

The number of positive microbial wound cultures on hospital day 8

Timeframe: Hospital Day 8

The number of positive microbial wound cultures on hospital day 12

Timeframe: Hospital Day 12

The number of positive microbial wound cultures on hospital day 16

Timeframe: Hospital Day 16

The number of positive microbial wound cultures on hospital day 20

Timeframe: Hospital Day 20

The number of positive microbial wound cultures on hospital day 24

Timeframe: Hospital Day 24

Trial details

NCT IDNCT06266494

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Blaire Balstad

303-724-7803 blaire.balstad@cuanschutz.edu

View on ClinicalTrials.gov More Frostbite trials