Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

University of Colorado Denver (CU Denver)

Status and phase: Enrolling; Phase 4

Conditions: Frostbite

Treatments: Drug: Dalbavancin; Device: Long-Acting silver dressings; Other: Aloe Vera

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06266494

23-1349

CDMRP-DM220077 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Aim 1: Aloe Vera

Active Comparator group

Description:

Aloe Vera will be applied topically to participant's frostbitten tissues twice daily.

Treatment:

Other: Aloe Vera

Aim 1: Long-Acting Silver Dressings

Experimental group

Description:

Long-Acting Silver dressings will be applied topically to participant's frostbitten tissues every 4 days.

Treatment:

Device: Long-Acting silver dressings

Aim 2: Dalbavancin

Experimental group

Description:

Participants will receive one 1500mg dose of Dalbavancin intravenously.

Treatment:

Drug: Dalbavancin