Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis
NCT ID: NCT06266494
Last Updated: 2024-05-13
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
RECRUITING
Clinical Phase
PHASE4
Total Enrollment
100 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-03-01
Study Completion Date
2026-08-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Frostbite
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Aim 1: Aloe Vera
Aloe Vera will be applied topically to participant's frostbitten tissues twice daily.
Group Type
ACTIVE_COMPARATOR
Aloe Vera
Intervention Type
OTHER
Dermaid Aloe Vera
Aim 1: Long-Acting Silver Dressings
Long-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days.
Group Type
EXPERIMENTAL
Long-Acting silver dressings
Intervention Type
DEVICE
Mepilex Transfer Ag
Aim 2: Dalbavancin
Participants will receive one 1500mg dose of Dalbavancin intravenously.
Group Type
EXPERIMENTAL
Dalbavancin
Intervention Type
DRUG
1500mg IV dose
Interventions
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Long-Acting silver dressings
Mepilex Transfer Ag
Intervention Type
DEVICE
Aloe Vera
Dermaid Aloe Vera
Intervention Type
OTHER
Dalbavancin
1500mg IV dose
Intervention Type
DRUG
Eligibility Criteria
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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
* 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)
* 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)
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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Congressionally Directed Medical Research Programs
FED
Sponsor Role
collaborator
University of Colorado, Denver
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Arek Wiktor, MD
Role: PRINCIPAL_INVESTIGATOR
University of Colorado Anschtuz
Locations
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University of Colorado Denver Anschutz Medical Campus
Aurora, Colorado, United States
Site Status
RECRUITING
Countries
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United States
Central Contacts
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Facility Contacts
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References
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Mueller SW, Blass B, Molina KC, Gibson C, Krsak M, Kohler AD, Deeter L, Stalilonis J, Wiktor AJ. Augmented Renal Function in Burn Patients: Occurrence and Discordance With Commonly Used Methods to Assess Renal Function. J Burn Care Res. 2023 Nov 2;44(6):1298-1303. doi: 10.1093/jbcr/irad107.
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Other Identifiers
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CDMRP-DM220077
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
23-1349
Identifier Type: -
Identifier Source: org_study_id
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