Frostbite
Conditions
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.
Interventions
DEVICELong-Acting silver dressings
Mepilex Transfer Ag
OTHERAloe Vera
Dermaid Aloe Vera
DRUGDalbavancin
1500mg IV dose
Sponsors
Congressionally Directed Medical Research Programs
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactBlaire Balstad
Backup ContactTracey MacDermott
Outcome results
None listed