[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100536566":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":41,"centralContacts":46,"locations":56,"responsibleParty":74,"collaborators":76,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":31,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":31,"overallStatus":59,"whyStopped":31,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"University of Colorado, Denver","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Aim 1: Aloe Vera","ACTIVE_COMPARATOR","Aloe Vera will be applied topically to participant's frostbitten tissues twice daily.",[13],"Other: Aloe Vera",{"label":15,"type":16,"description":17,"interventionNames":18},"Aim 1: Long-Acting Silver Dressings","EXPERIMENTAL","Long-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days.",[19],"Device: Long-Acting silver dressings",{"label":21,"type":16,"description":22,"interventionNames":23},"Aim 2: Dalbavancin","Participants will receive one 1500mg dose of Dalbavancin intravenously.",[24],"Drug: Dalbavancin",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Long-Acting silver dressings","Mepilex Transfer Ag",[15],null,{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Aloe Vera","Dermaid Aloe Vera",[9],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"DRUG","Dalbavancin","1500mg IV dose",[21],[42],{"name":43,"affiliation":44,"role":45},"Arek Wiktor, MD","University of Colorado Anschtuz","PRINCIPAL_INVESTIGATOR",[47,52],{"name":48,"role":49,"phone":50,"phoneExt":31,"email":51},"Blaire Balstad","CONTACT","303-724-7803","blaire.balstad@cuanschutz.edu",{"name":53,"role":49,"phone":54,"phoneExt":31,"email":55},"Tracey MacDermott","303-724-2757","tracey.macdermott@cuanschutz.edu",[57],{"facility":58,"status":59,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"University of Colorado Denver Anschutz Medical Campus","RECRUITING","Aurora","Colorado","80045","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-104.83192,39.72943,{"lat":69,"lon":68},[72,73],{"name":48,"role":49,"phone":50,"phoneExt":31,"email":51},{"name":53,"role":49,"phone":54,"phoneExt":31,"email":55},{"type":75,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR",[77],{"name":78,"class":79},"Congressionally Directed Medical Research Programs","FED","100536566","phase-4-prevention-and-treatment-of-frostbite-infection-with-antimicrobial-pharmacokinetic-analysis-100536566",false,"NCT06266494","Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis","Frostbite","Inclusion Criteria:\n\n* All aims, aged ≥18 - \\\u003C 99 years old admitted to UCH Burn Center with frostbite injury\n* Aim 1: Admitted to UCH Burn Center with acute (within 4 days of cold exposure) frostbite injury\n* Aim 2: Admitted to UCH Burn center with a clinically confirmed or suspected infected frostbite wound\n\nExclusion Criteria:\n\n* Pregnant patients\n* Prisoners\n* Anticipated death within 48 hours of admission\n* Inability to obtain consent from patient, legally authorized representative, or proxy\n* 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).\n* 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.\n* Aim 3: Anuria due to chronic kidney disease (CKD)",true,"ALL","18 Years","99 Years",{"count":92,"type":93},100,"ESTIMATED","INTERVENTIONAL",[96],"PHASE4","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.",[85],"2024-05-10",{"date":101,"type":102},"2024-05-13","ACTUAL",{"date":104,"type":102},"2024-03-01",{"date":106,"type":93},"2026-08",{"name":5,"class":6},1]