Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

• Long-Acting silver dressings (Device): Mepilex Transfer Ag
• Aloe Vera (Other): Dermaid Aloe Vera
• Dalbavancin (Drug): 1500mg IV dose

Primary outcomes

• The number of positive microbial wound cultures on admission [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [Up to 12 weeks]: Dalbavancin concentration measured in frostbitten subcutaneous tissue by mcg/g
• Change in presence of Augmented Renal Clearance [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.

Sex: All, ages: 18 Years to 99 Years, accepts healthy volunteers

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)

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• Arek Wiktor, MD, Principal investigator, University of Colorado Anschtuz