Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Overview

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.

Interventions

• Device Long-Acting silver dressings
  Mepilex Transfer Ag
• Other Aloe Vera
  Dermaid Aloe Vera
• Drug Dalbavancin
  1500mg IV dose

Primary outcome measures

• 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]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Colorado Denver Anschutz Medical Campus — Aurora

Publications

• 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. PMID 37450897
• Carmichael H, Michel S, Smith TM, Duffy PS, Wiktor AJ, Lambert Wagner A. Remote Delivery of Thrombolytics Prior to Transfer to a Regional Burn Center for Tissue Salvage in Frostbite: A Single-center Experience of 199 Patients. J Burn Care Res. 2022 Jan 5;43(1):54-60. doi: 10.1093/jbcr/irab041. PMID 33657205
• Torian SC, Wiktor AJ, Roper SE, Laramie KE, Miller MA, Mueller SW. Burn Injury and Augmented Renal Clearance: A Case for Optimized Piperacillin-Tazobactam Dosing. J Burn Care Res. 2023 Jan 5;44(1):203-206. doi: 10.1093/jbcr/irac138. PMID 36173707
• Barletta JF, Mangram AJ, Byrne M, Sucher JF, Hollingworth AK, Ali-Osman FR, Shirah GR, Haley M, Dzandu JK. Identifying augmented renal clearance in trauma patients: Validation of the Augmented Renal Clearance in Trauma Intensive Care scoring system. J Trauma Acute Care Surg. 2017 Apr;82(4):665-671. doi: 10.1097/TA.0000000000001387. PMID 28129261
• Udy AA, Jarrett P, Stuart J, Lassig-Smith M, Starr T, Dunlop R, Wallis SC, Roberts JA, Lipman J. Determining the mechanisms underlying augmented renal drug clearance in the critically ill: use of exogenous marker compounds. Crit Care. 2014 Nov 29;18(6):657. doi: 10.1186/s13054-014-0657-z. PMID 25432141
• Cook AM, Hatton-Kolpek J. Augmented Renal Clearance. Pharmacotherapy. 2019 Mar;39(3):346-354. doi: 10.1002/phar.2231. Epub 2019 Mar 11. PMID 30723936
• Dunne MW, Puttagunta S, Giordano P, Krievins D, Zelasky M, Baldassarre J. A Randomized Clinical Trial of Single-Dose Versus Weekly Dalbavancin for Treatment of Acute Bacterial Skin and Skin Structure Infection. Clin Infect Dis. 2016 Mar 1;62(5):545-51. doi: 10.1093/cid/civ982. Epub 2015 Nov 26. PMID 26611777
• Carrothers TJ, Chittenden JT, Critchley I. Dalbavancin Population Pharmacokinetic Modeling and Target Attainment Analysis. Clin Pharmacol Drug Dev. 2020 Jan;9(1):21-31. doi: 10.1002/cpdd.695. Epub 2019 May 14. PMID 31087630

Identifiers

NCT: NCT06266494 · 23-1349 · CDMRP-DM220077

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗