nctId: NCT06266494 id: 23-1349 id: CDMRP-DM220077 type: OTHER_GRANT domain: Department of Defense briefTitle: Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis acronym: Frostbite overallStatus: NOT_YET_RECRUITING date: 2024-02 date: 2026-05 date: 2026-08 date: 2024-02-20 date: 2024-02-20 name: University of Colorado, Denver class: OTHER name: Congressionally Directed Medical Research Programs briefSummary: 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. conditions: Frostbite studyType: INTERVENTIONAL phases: PHASE4 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 100 type: ESTIMATED name: Long-Acting silver dressings name: Aloe Vera name: Dalbavancin measure: The number of positive microbial wound cultures on admission measure: The number of positive microbial wound cultures on hospital day 4 measure: The number of positive microbial wound cultures on hospital day 8 measure: The number of positive microbial wound cultures on hospital day 12 measure: The number of positive microbial wound cultures on hospital day 16 measure: The number of positive microbial wound cultures on hospital day 20 measure: The number of positive microbial wound cultures on hospital day 24 measure: The number of positive microbial wound cultures on hospital day 28 measure: The number of positive microbial wound cultures on hospital day 32 measure: The number of positive microbial wound cultures on hospital day 36 measure: The number of positive microbial wound cultures on hospital day 40 measure: The number of positive microbial wound cultures on hospital day 44 measure: The number of positive microbial wound cultures on hospital day 48 measure: The number of positive microbial wound cultures on hospital day 52 measure: The number of positive microbial wound cultures on hospital day 56 measure: The number of positive microbial wound cultures on hospital day 60 measure: Number of gram positive cultures at admission measure: Number of gram positive cultures on hospital day 4 measure: Number of gram positive cultures on hospital day 8 measure: Number of gram positive cultures on hospital day 12 measure: Number of gram positive cultures on hospital day 16 measure: Number of gram positive cultures on hospital day 20 measure: Number of gram positive cultures on hospital day 24 measure: Number of gram positive cultures on hospital day 28 measure: Number of gram positive cultures on hospital day 32 measure: Number of gram positive cultures on hospital day 36 measure: Number of gram positive cultures on hospital day 40 measure: Number of gram positive cultures on hospital day 44 measure: Number of gram positive cultures on hospital day 48 measure: Number of gram positive cultures on hospital day 52 measure: Number of gram positive cultures on hospital day 56 measure: Number of gram positive cultures on hospital day 60 measure: Change in serum concentration of dalbavancin in plasma (mcg/ml) over time measure: Dalbavancin concentrations in subcutaneous tissue measure: Change in presence of Augmented Renal Clearance sex: ALL minimumAge: 18 Years maximumAge: 99 Years stdAges: ADULT stdAges: OLDER_ADULT facility: University of Colorado Denver Anschutz Medical Campus city: Aurora state: Colorado zip: 80045 country: United States name: Blaire Balstad role: CONTACT phone: 303-724-7803 email: blaire.balstad@cuanschutz.edu name: Tracey MacDermott role: CONTACT phone: 303-724-2757 email: tracey.macdermott@cuanschutz.edu lat: 39.72943 lon: -104.83192 hasResults: False