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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

Inclusion 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

Exclusion Criteria

  • 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)

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Aim 1: Aloe Vera 		Aloe Vera will be applied topically to participant's frostbitten tissues twice daily.
  • Other: Aloe Vera
    Dermaid Aloe Vera
Experimental
Aim 1: Long-Acting Silver Dressings 		Long-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days.
  • Device: Long-Acting silver dressings
    Mepilex Transfer Ag
Experimental
Aim 2: Dalbavancin 		Participants will receive one 1500mg dose of Dalbavancin intravenously.
  • Drug: Dalbavancin
    1500mg IV dose

Recruiting Locations

University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado 80045
Contact:
Blaire Balstad
303-724-7803
blaire.balstad@cuanschutz.edu

More Details

Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Blaire Balstad
303-724-7803
blaire.balstad@cuanschutz.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.