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