RECRUITING

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Quick Facts

Study Start:2024-03-01
Study Completion:2026-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06266494

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.

Ages Eligible for Study:18 Years to 99 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * All aims, aged ≥18 - \< 99 years old admitted to UCH Burn Center with frostbite injury
  2. * Aim 1: Admitted to UCH Burn Center with acute (within 4 days of cold exposure) frostbite injury
  3. * Aim 2: Admitted to UCH Burn center with a clinically confirmed or suspected infected frostbite wound
  1. * Pregnant patients
  2. * Prisoners
  3. * Anticipated death within 48 hours of admission
  4. * Inability to obtain consent from patient, legally authorized representative, or proxy
  5. * 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).
  6. * 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.
  7. * Aim 3: Anuria due to chronic kidney disease (CKD)

Contacts and Locations

Study Contact

Blaire Balstad
CONTACT
303-724-7803
blaire.balstad@cuanschutz.edu
Tracey MacDermott
CONTACT
303-724-2757
tracey.macdermott@cuanschutz.edu

Principal Investigator

Arek Wiktor, MD
PRINCIPAL_INVESTIGATOR
University of Colorado Anschtuz

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Colorado, Denver

  • Arek Wiktor, MD, PRINCIPAL_INVESTIGATOR, University of Colorado Anschtuz

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2026-08

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2026-08

Terms related to this study

Additional Relevant MeSH Terms

  • Frostbite