Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Description

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

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Study Overview

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Study Details

Study overview

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.

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Condition
Frostbite
Intervention / Treatment

-

Contacts and Locations

Aurora

University of Colorado Denver Anschutz Medical Campus, Aurora, Colorado, United States, 80045

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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)

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Colorado, Denver,

Arek Wiktor, MD, PRINCIPAL_INVESTIGATOR, University of Colorado Anschtuz

Study Record Dates

2026-08