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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Mepilex Transfer Ag
Dermaid Aloe Vera
1500mg IV dose
University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States
RECRUITINGThe number of positive microbial wound cultures on 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.
Time frame: Admission
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 4
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 8
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 12
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 16
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 20
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 24
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 28
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 32
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 36
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 40
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 44
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 48
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 52
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 56
The number of positive microbial wound cultures on 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.
Time frame: Hospital Day 60
Number of gram positive cultures at admission
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Admission
Number of gram positive cultures on hospital day 4
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 4
Number of gram positive cultures on hospital day 8
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 8
Number of gram positive cultures on hospital day 12
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 12
Number of gram positive cultures on hospital day 16
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 16
Number of gram positive cultures on hospital day 20
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 20
Number of gram positive cultures on hospital day 24
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 24
Number of gram positive cultures on hospital day 28
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 28
Number of gram positive cultures on hospital day 32
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 32
Number of gram positive cultures on hospital day 36
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 36
Number of gram positive cultures on hospital day 40
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 40
Number of gram positive cultures on hospital day 44
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 44
Number of gram positive cultures on hospital day 48
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 48
Number of gram positive cultures on hospital day 52
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 52
Number of gram positive cultures on hospital day 56
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 56
Number of gram positive cultures on hospital day 60
UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).
Time frame: Hospital Day 60
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
Dalbavancin concentration measured in frostbitten subcutaneous tissue by mcg/g
Time frame: Up to 12 weeks
Change in presence of Augmented Renal Clearance
Creatinine clearance will be calculated from a 12-hour urine collection, with the definition of Augmented Renal Clearance as: CrCl \> 130mL/min.
Time frame: Baseline, Up to 12 weeks
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