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RecruitingPhase 4NCT06266494

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Sponsor

University of Colorado, Denver

Enrollment

100 participants

Start Date

Mar 1, 2024

Study Type

INTERVENTIONAL

Conditions

Frostbite

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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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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Interventions

DEVICELong-Acting silver dressings

Mepilex Transfer Ag

OTHERAloe Vera

Dermaid Aloe Vera

DRUGDalbavancin

1500mg IV dose

Locations(1)

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, United States

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NCT06266494