Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Frostbite Clinical Trial

— Frostbite  

Official title:

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06266494
• Other study ID #: 23-1349
• Secondary ID: CDMRP-DM220077
• Status: Recruiting
• Phase: Phase 4
• Start date: March 1, 2024
• Est. completion date: August 2026

Study information

• Verified date: May 2024
• Source: University of Colorado, Denver
• Contact: Blaire Balstad
• Phone: 303-724-7803
• Email: blaire.balstad[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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)

Related Conditions & MeSH terms

• Frostbite

Intervention

Device:
• Long-Acting silver dressings
Mepilex Transfer Ag

Other:
• Aloe Vera
Dermaid Aloe Vera

Drug:
• Dalbavancin
1500mg IV dose

Locations

Country	Name	City	State
United States	University of Colorado Denver Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Congressionally Directed Medical Research Programs

Country where clinical trial is conducted

United States, 

References & Publications (43)

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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. — View Citation

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* Note: There are 43 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Dalbavancin concentrations in subcutaneous tissue	Dalbavancin concentration measured in frostbitten subcutaneous tissue by mcg/g	Up to 12 weeks
Primary	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