NCT06266494 · University of Colorado, Denver
Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
(Frostbite)
What this study 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.
View original scientific description
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.
Interventions
DEVICE
Long-Acting silver dressings
Mepilex Transfer Ag
OTHER
Aloe Vera
Dermaid Aloe Vera
DRUG
Dalbavancin
1500mg IV dose
Primary outcome measures
The number of positive microbial wound cultures on admission
Time frame: Admission
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 4
Time frame: Hospital Day 4
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 8
Time frame: Hospital Day 8
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 12
Time frame: Hospital Day 12
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 16
Time frame: Hospital Day 16
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 20
Time frame: Hospital Day 20
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 24
Time frame: Hospital Day 24
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 28
Time frame: Hospital Day 28
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 32
Time frame: Hospital Day 32
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 36
Time frame: Hospital Day 36
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 40
Time frame: Hospital Day 40
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 44
Time frame: Hospital Day 44
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 48
Time frame: Hospital Day 48
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 52
Time frame: Hospital Day 52
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 56
Time frame: Hospital Day 56
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
The number of positive microbial wound cultures on hospital day 60
Time frame: Hospital Day 60
Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.
Number of gram positive cultures at admission
Time frame: Admission
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 4
Time frame: Hospital Day 4
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 8
Time frame: Hospital Day 8
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 12
Time frame: Hospital Day 12
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 16
Time frame: Hospital Day 16
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 20
Time frame: Hospital Day 20
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 24
Time frame: Hospital Day 24
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 28
Time frame: Hospital Day 28
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 32
Time frame: Hospital Day 32
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 36
Time frame: Hospital Day 36
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 40
Time frame: Hospital Day 40
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 44
Time frame: Hospital Day 44
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 48
Time frame: Hospital Day 48
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 52
Time frame: Hospital Day 52
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 56
Time frame: Hospital Day 56
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Number of gram positive cultures on hospital day 60
Time frame: Hospital Day 60
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Change in serum concentration of dalbavancin in plasma (mcg/ml) over time
Time frame: 1, 4, 12 hours, and 1,2,3,4,6,8,10,13,16 (or date of discharge if earlier) days post dalbavancin infusion
Dalbavancin concentrations in subcutaneous tissue
Time frame: Up to 12 weeks
Dalbavancin concentration measured in frostbitten subcutaneous tissue by mcg/g
Change in presence of Augmented Renal Clearance
Time frame: Baseline, Up to 12 weeks
Creatinine clearance will be calculated from a 12-hour urine collection, with the definition of Augmented Renal Clearance as: CrCl \> 130mL/min.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
- Aurora, Colorado
Collaborators
Congressionally Directed Medical Research Programs
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 13, 2024 · Source of record for eligibility and locations