Health TrialsbyHealthPanel

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

ConditionFrostbite
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-99
SponsorUniversity of Colorado, Denver

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnant patients

Prisoners

Anticipated death within 48 hours of admission

Inability to obtain consent from patient, legally authorized representative, or proxy

Trial design

Design model

Parallel

Treatments tested in this trial

  • Long-Acting silver dressings

    Device

    Mepilex Transfer Ag

  • Aloe Vera

    Other intervention

    Dermaid Aloe Vera

  • Dalbavancin

    Drug

    1500mg IV dose

Treatment groups

100 Participants
are divided into 3 treatment groups
Group A: Aim 1: Aloe VeraActive comparator 1 intervention
Group B: Aim 1: Long-Acting Silver DressingsExperimental treatment 1 intervention
Group C: Aim 2: DalbavancinExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The number of positive microbial wound cultures on admission

Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

Time frame
Admission
2

The number of positive microbial wound cultures on hospital day 4

Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

Time frame
Hospital Day 4
3

The number of positive microbial wound cultures on hospital day 8

Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

Time frame
Hospital Day 8
4

The number of positive microbial wound cultures on hospital day 12

Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.

Time frame
Hospital Day 12

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Colorado, Denver

Lead sponsor

Congressionally Directed Medical Research Programs

Collaborator

Source ClinicalTrials.gov
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