Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- The number of positive microbial wound cultures on admission
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
Aim 1: Aloe Vera
Aloe Vera will be applied topically to participant's frostbitten tissues twice daily.
Intervention: Aloe Vera (Other)
Aim 1: Long-Acting Silver Dressings
Long-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days.
Intervention: Long-Acting silver dressings (Device)
Aim 2: Dalbavancin
Participants will receive one 1500mg dose of Dalbavancin intravenously.
Intervention: Dalbavancin (Drug)
Outcomes
Primary Outcomes
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.
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).
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.
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).
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 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 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.
Secondary Outcomes
No secondary outcomes reported