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NCT Number: NCT06266494

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

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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Key information

Conditions

Frostbite Cold Injury Wounds and Injuries

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Long-Acting silver dressings

Device

Mepilex Transfer Ag

Aloe vera

Other

Dermaid Aloe Vera

Dalbavancin

Drug

1500mg IV dose

Primary outcomes

  1. The number of positive microbial wound cultures on admission

    Time frame: 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.

  2. The number of positive microbial wound cultures on hospital day 4

    Time frame: 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.

  3. The number of positive microbial wound cultures on hospital day 8

    Time frame: 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.

  4. The number of positive microbial wound cultures on hospital day 12

    Time frame: 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.

  5. The number of positive microbial wound cultures on hospital day 16

    Time frame: 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.

  6. The number of positive microbial wound cultures on hospital day 20

    Time frame: 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.

  7. The number of positive microbial wound cultures on hospital day 24

    Time frame: 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.

  8. The number of positive microbial wound cultures on hospital day 28

    Time frame: 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.

  9. The number of positive microbial wound cultures on hospital day 32

    Time frame: 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.

  10. The number of positive microbial wound cultures on hospital day 36

    Time frame: 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.

  11. The number of positive microbial wound cultures on hospital day 40

    Time frame: 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.

  12. The number of positive microbial wound cultures on hospital day 44

    Time frame: 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.

  13. The number of positive microbial wound cultures on hospital day 48

    Time frame: 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.

  14. The number of positive microbial wound cultures on hospital day 52

    Time frame: 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.

  15. The number of positive microbial wound cultures on hospital day 56

    Time frame: 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.

  16. The number of positive microbial wound cultures on hospital day 60

    Time frame: 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.

  17. Number of gram positive cultures at admission

    Time frame: Admission

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  18. Number of gram positive cultures on hospital day 4

    Time frame: Hospital Day 4

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  19. Number of gram positive cultures on hospital day 8

    Time frame: Hospital Day 8

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  20. Number of gram positive cultures on hospital day 12

    Time frame: Hospital Day 12

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  21. Number of gram positive cultures on hospital day 16

    Time frame: Hospital Day 16

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  22. Number of gram positive cultures on hospital day 20

    Time frame: Hospital Day 20

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  23. Number of gram positive cultures on hospital day 24

    Time frame: Hospital Day 24

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  24. Number of gram positive cultures on hospital day 28

    Time frame: Hospital Day 28

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  25. Number of gram positive cultures on hospital day 32

    Time frame: Hospital Day 32

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  26. Number of gram positive cultures on hospital day 36

    Time frame: Hospital Day 36

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  27. Number of gram positive cultures on hospital day 40

    Time frame: Hospital Day 40

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  28. Number of gram positive cultures on hospital day 44

    Time frame: Hospital Day 44

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  29. Number of gram positive cultures on hospital day 48

    Time frame: Hospital Day 48

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  30. Number of gram positive cultures on hospital day 52

    Time frame: Hospital Day 52

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  31. Number of gram positive cultures on hospital day 56

    Time frame: Hospital Day 56

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  32. Number of gram positive cultures on hospital day 60

    Time frame: Hospital Day 60

    UCH clinical laboratory will identify cultures using MALDI-TOF MS (Matrix-Assisted Laser Desorption - Ionisation-Time of Flight Mass Spectrometry).

  33. 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

  34. Dalbavancin concentrations in subcutaneous tissue

    Time frame: Up to 12 weeks

    Dalbavancin concentration measured in frostbitten subcutaneous tissue by mcg/g

  35. Change in presence of Augmented Renal Clearance

    Time frame: Baseline, Up to 12 weeks

    Creatinine clearance will be calculated from a 12-hour urine collection, with the definition of Augmented Renal Clearance as: CrCl > 130mL/min.

Study contacts

Contact information is provided by the study sponsor or research team.

Blaire Balstad

CONTACT

[email protected]

303-724-7803

Tracey MacDermott

CONTACT

[email protected]

303-724-2757

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Acronym: Frostbite

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 20, 2024
Registry last updated
May 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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