Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis (Frostbite)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Frostbite
• Intervention / Treatment: Other: Aloe Vera; Device: Long-Acting silver dressings; Drug: Dalbavancin

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Tracey MacDermott; Phone Number: 303-724-2757; Email: tracey.macdermott@cuanschutz.edu
• Study Contact Backup: Name: Blaire Balstad; Phone Number: 303-724-7803; Email: blaire.balstad@cuanschutz.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Denver Anschutz Medical Campus
      • Contact: Tracey MacDermott; Phone Number: 303-724-2757; Email: tracey.macdermott@cuanschutz.edu
      • Contact: Blaire Balstad; Phone Number: 303-724-7803; Email: blaire.balstad@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of positive microbial wound cultures on admission	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Admission
The number of positive microbial wound cultures on hospital day 4	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 4
The number of positive microbial wound cultures on hospital day 8	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 8
The number of positive microbial wound cultures on hospital day 12	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 12
The number of positive microbial wound cultures on hospital day 16	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 16
The number of positive microbial wound cultures on hospital day 20	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 20
The number of positive microbial wound cultures on hospital day 24	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 24
The number of positive microbial wound cultures on hospital day 28	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 28
The number of positive microbial wound cultures on hospital day 32	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 32
The number of positive microbial wound cultures on hospital day 36	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 36
The number of positive microbial wound cultures on hospital day 40	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 40
The number of positive microbial wound cultures on hospital day 44	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 44
The number of positive microbial wound cultures on hospital day 48	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 48
The number of positive microbial wound cultures on hospital day 52	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 52
The number of positive microbial wound cultures on hospital day 56	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 56
The number of positive microbial wound cultures on hospital day 60	Aerobic wound swabs will be taken from area of frostbite injury and analyzed by the (University of Colorado Hospital) UCH clinical laboratory. A positive culture indicates an organism was identified by the wound swab.	Hospital Day 60
Number of gram positive cultures at admission	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Admission
Number of gram positive cultures on hospital day 4	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 4
Number of gram positive cultures on hospital day 8	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 8
Number of gram positive cultures on hospital day 12	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 12
Number of gram positive cultures on hospital day 16	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 16
Number of gram positive cultures on hospital day 20	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 20
Number of gram positive cultures on hospital day 24	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 24
Number of gram positive cultures on hospital day 28	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 28
Number of gram positive cultures on hospital day 32	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 32
Number of gram positive cultures on hospital day 36	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 36
Number of gram positive cultures on hospital day 40	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 40
Number of gram positive cultures on hospital day 44	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 44
Number of gram positive cultures on hospital day 48	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 48
Number of gram positive cultures on hospital day 52	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 52
Number of gram positive cultures on hospital day 56	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 56
Number of gram positive cultures on hospital day 60	UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).	Hospital Day 60
Change in serum concentration of dalbavancin in plasma (mcg/ml) over time		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	Dalbavancin concentration measured in frostbitten subcutaneous tissue by mcg/g	Up to 12 weeks
Change in presence of Augmented Renal Clearance	Creatinine clearance will be calculated from a 12-hour urine collection, with the definition of Augmented Renal Clearance as: CrCl > 130mL/min.	Baseline, Up to 12 weeks

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Collaborators: Congressionally Directed Medical Research Programs
• Investigators: Principal Investigator: Arek Wiktor, MD, University of Colorado Anschtuz

Publications and helpful links

General Publications

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• Cook AM, Hatton-Kolpek J. Augmented Renal Clearance. Pharmacotherapy. 2019 Mar;39(3):346-354. doi: 10.1002/phar.2231. Epub 2019 Mar 11.
• 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.
• 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.
• 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.
• 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.
• 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.
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• Dunne MW, Puttagunta S, Sprenger CR, Rubino C, Van Wart S, Baldassarre J. Extended-duration dosing and distribution of dalbavancin into bone and articular tissue. Antimicrob Agents Chemother. 2015 Apr;59(4):1849-55. doi: 10.1128/AAC.04550-14. Epub 2015 Jan 5.
• Nicolau DP, Sun HK, Seltzer E, Buckwalter M, Dowell JA. Pharmacokinetics of dalbavancin in plasma and skin blister fluid. J Antimicrob Chemother. 2007 Sep;60(3):681-4. doi: 10.1093/jac/dkm263. Epub 2007 Jul 12.
• Morrisette T, Miller MA, Montague BT, Barber GR, McQueen RB, Krsak M. On- and off-label utilization of dalbavancin and oritavancin for Gram-positive infections. J Antimicrob Chemother. 2019 Aug 1;74(8):2405-2416. doi: 10.1093/jac/dkz162.
• Molina KC, Lunowa C, Lebin M, Segerstrom Nunez A, Azimi SF, Krsak M, Mueller SW, Miller MA. Comparison of Sequential Dalbavancin With Standard-of-Care Treatment for Staphylococcus aureus Bloodstream Infections. Open Forum Infect Dis. 2022 Jul 14;9(7):ofac335. doi: 10.1093/ofid/ofac335. eCollection 2022 Jul.
• Cain AR, Bremmer DN, Carr DR, Buchanan C, Jacobs M, Walsh TL, Moffa MA, Shively NR, Trienski TL. Effectiveness of Dalbavancin Compared With Standard of Care for the Treatment of Osteomyelitis: A Real-world Analysis. Open Forum Infect Dis. 2021 Dec 18;9(2):ofab589. doi: 10.1093/ofid/ofab589. eCollection 2022 Feb.
• Rappo U, Puttagunta S, Shevchenko V, Shevchenko A, Jandourek A, Gonzalez PL, Suen A, Mas Casullo V, Melnick D, Miceli R, Kovacevic M, De Bock G, Dunne MW. Dalbavancin for the Treatment of Osteomyelitis in Adult Patients: A Randomized Clinical Trial of Efficacy and Safety. Open Forum Infect Dis. 2018 Dec 10;6(1):ofy331. doi: 10.1093/ofid/ofy331. eCollection 2019 Jan.
• Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne MW. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med. 2014 Jun 5;370(23):2169-79. doi: 10.1056/NEJMoa1310480.
• Jones RN, Fritsche TR, Sader HS, Goldstein BP. Antimicrobial spectrum and potency of dalbavancin tested against clinical isolates from Europe and North America (2003): initial results from an international surveillance protocol. J Chemother. 2005 Dec;17(6):593-600. doi: 10.1179/joc.2005.17.6.593.
• Molina KC, Miller MA, Mueller SW, Van Matre ET, Krsak M, Kiser TH. Clinical Pharmacokinetics and Pharmacodynamics of Dalbavancin. Clin Pharmacokinet. 2022 Mar;61(3):363-374. doi: 10.1007/s40262-021-01088-w. Epub 2021 Dec 21.
• Sader HS, Castanheira M, Huband MD, Shortridge D, Carvalhaes CG, Mendes RM. Antimicrobial activity of dalbavancin against Gram-positive bacteria isolated from patients hospitalized with bloodstream infection in United States and European medical centers (2018-2020). Eur J Clin Microbiol Infect Dis. 2022 May;41(5):867-873. doi: 10.1007/s10096-022-04437-0. Epub 2022 Mar 30.
• Goldstein EJ, Citron DM, Warren YA, Tyrrell KL, Merriam CV, Fernandez HT. In vitro activities of dalbavancin and 12 other agents against 329 aerobic and anaerobic gram-positive isolates recovered from diabetic foot infections. Antimicrob Agents Chemother. 2006 Aug;50(8):2875-9. doi: 10.1128/AAC.00286-06.
• Madry R, Struzyna J, Stachura-Kulach A, Drozdz L, Bugaj M. Effectiveness of Suprathel(R) application in partial thickness burns, frostbites and Lyell syndrome treatment. Pol Przegl Chir. 2011 Oct;83(10):541-8. doi: 10.2478/v10035-011-0086-5.
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• Goertz O, Hirsch T, Buschhaus B, Daigeler A, Vogelpohl J, Langer S, Steinau HU, Ring A. Intravital pathophysiologic comparison of frostbite and burn injury in a murine model. J Surg Res. 2011 May 15;167(2):e395-401. doi: 10.1016/j.jss.2011.01.034. Epub 2011 Feb 18.
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• Imray C, Grieve A, Dhillon S; Caudwell Xtreme Everest Research Group. Cold damage to the extremities: frostbite and non-freezing cold injuries. Postgrad Med J. 2009 Sep;85(1007):481-8. doi: 10.1136/pgmj.2008.068635.
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Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Cold Injury; Frostbite; Anti-Infective Agents; Anti-Bacterial Agents; Dalbavancin
• Other Study ID Numbers: 23-1349; CDMRP-DM220077 (Other Grant/Funding Number: Department of Defense)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Undetermined at this time

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes