Recruiting

Antimicrobial Analysis

Sponsor:

University of Colorado, Denver

Code:

NCT06266494

Conditions

Frostbite

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Long-Acting silver dressings

Aloe Vera

Dalbavancin

Study Details

Brief 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.

Conditions

Frostbite

Study ID

NCT06266494

Start date

Mar 1, 2024

Status verified date

May, 2024

Completion date

Aug, 2026

Anticipated

Primary completion date

May, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Long-Acting silver dressings

Mepilex Transfer Ag

Aloe Vera

Dermaid Aloe Vera

Dalbavancin

1500mg IV dose

Primary outcome measure

  • The number of positive microbial wound cultures on admission [ Time Frame: Admission ]
  • The number of positive microbial wound cultures on hospital day 4 [ Time Frame: Hospital Day 4 ]
  • The number of positive microbial wound cultures on hospital day 8 [ Time Frame: Hospital Day 8 ]
  • The number of positive microbial wound cultures on hospital day 12 [ Time Frame: Hospital Day 12 ]
  • The number of positive microbial wound cultures on hospital day 16 [ Time Frame: Hospital Day 16 ]
  • The number of positive microbial wound cultures on hospital day 20 [ Time Frame: Hospital Day 20 ]
  • The number of positive microbial wound cultures on hospital day 24 [ Time Frame: Hospital Day 24 ]
  • The number of positive microbial wound cultures on hospital day 28 [ Time Frame: Hospital Day 28 ]
  • The number of positive microbial wound cultures on hospital day 32 [ Time Frame: Hospital Day 32 ]
  • The number of positive microbial wound cultures on hospital day 36 [ Time Frame: Hospital Day 36 ]
  • The number of positive microbial wound cultures on hospital day 40 [ Time Frame: Hospital Day 40 ]
  • The number of positive microbial wound cultures on hospital day 44 [ Time Frame: Hospital Day 44 ]
  • The number of positive microbial wound cultures on hospital day 48 [ Time Frame: Hospital Day 48 ]
  • The number of positive microbial wound cultures on hospital day 52 [ Time Frame: Hospital Day 52 ]
  • The number of positive microbial wound cultures on hospital day 56 [ Time Frame: Hospital Day 56 ]
  • The number of positive microbial wound cultures on hospital day 60 [ Time Frame: Hospital Day 60 ]
  • Number of gram positive cultures at admission [ Time Frame: Admission ]
  • Number of gram positive cultures on hospital day 4 [ Time Frame: Hospital Day 4 ]
  • Number of gram positive cultures on hospital day 8 [ Time Frame: Hospital Day 8 ]
  • Number of gram positive cultures on hospital day 12 [ Time Frame: Hospital Day 12 ]
  • Number of gram positive cultures on hospital day 16 [ Time Frame: Hospital Day 16 ]
  • Number of gram positive cultures on hospital day 20 [ Time Frame: Hospital Day 20 ]
  • Number of gram positive cultures on hospital day 24 [ Time Frame: Hospital Day 24 ]
  • Number of gram positive cultures on hospital day 28 [ Time Frame: Hospital Day 28 ]
  • Number of gram positive cultures on hospital day 32 [ Time Frame: Hospital Day 32 ]
  • Number of gram positive cultures on hospital day 36 [ Time Frame: Hospital Day 36 ]
  • Number of gram positive cultures on hospital day 40 [ Time Frame: Hospital Day 40 ]
  • Number of gram positive cultures on hospital day 44 [ Time Frame: Hospital Day 44 ]
  • Number of gram positive cultures on hospital day 48 [ Time Frame: Hospital Day 48 ]
  • Number of gram positive cultures on hospital day 52 [ Time Frame: Hospital Day 52 ]
  • Number of gram positive cultures on hospital day 56 [ Time Frame: Hospital Day 56 ]
  • Number of gram positive cultures on hospital day 60 [ Time Frame: Hospital Day 60 ]
  • Change in serum concentration of dalbavancin in plasma (mcg/ml) over time [ Time Frame: 1, 4, 12 hours, and 1,2,3,4,6,8,10,13,16 (or date of discharge if earlier) days post dalbavancin infusion ]
  • Dalbavancin concentrations in subcutaneous tissue [ Time Frame: Up to 12 weeks ]
  • Change in presence of Augmented Renal Clearance [ Time Frame: Baseline, Up to 12 weeks ]

Central Contacts and Locations

Central contacts

Blaire Balstad

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

Tracey MacDermott

303-724-2757tracey.macdermott@cuanschutz.edu

Locations

University of Colorado Denver Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Blaire Balstad

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

Tracey MacDermott

303-724-2757tracey.macdermott@cuanschutz.edu

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 13, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-05-13.