Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT06266494
Phase
PHASE4
Status
Recruiting
Apply to this trial

Conditions

  • Frostbite

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Long-Acting silver dressings — DEVICE
    Mepilex Transfer Ag
  • Aloe Vera — OTHER
    Dermaid Aloe Vera
  • Dalbavancin — DRUG
    1500mg IV dose

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
May 2024
Primary completion
May 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

The number of positive microbial wound cultures on admission [ Time Frame: Admission ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado Denver Anschutz Medical CampusAuroraColorado80045
Blaire Balstad
[email protected]
303-724-7803
Tracey MacDermott
[email protected]
303-724-2757

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By research site
University of Colorado Denver Anschutz Medical Campus· Aurora, CO

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