Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device, Other
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
View:

• 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

Locations
United States
Colorado
University of Colorado Denver Anschutz Medical Campus
RECRUITING
Aurora
Contact Information
Primary
Blaire Balstad
blaire.balstad@cuanschutz.edu
303-724-7803
Backup
Tracey MacDermott
tracey.macdermott@cuanschutz.edu
303-724-2757
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-08
Participants
Target number of participants: 100
Treatments
Active_comparator: Aim 1: Aloe Vera
Aloe Vera will be applied topically to participant's frostbitten tissues twice daily.
Experimental: Aim 1: Long-Acting Silver Dressings
Long-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days.
Experimental: Aim 2: Dalbavancin
Participants will receive one 1500mg dose of Dalbavancin intravenously.
Related Therapeutic Areas
Sponsors
Collaborators: Congressionally Directed Medical Research Programs
Leads: University of Colorado, Denver

This content was sourced from clinicaltrials.gov