Actively Recruiting

Phase 4
Age: 18Years - 99Years
All Genders
Healthy Volunteers
NCT06266494

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Led by University of Colorado, Denver · Updated on 2024-05-13

100

Participants Needed

1

Research Sites

126 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

C

Congressionally Directed Medical Research Programs

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

Who Can Participate

Age: 18Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 18 to less than 99 years admitted to UCH Burn Center with frostbite injury
  • For prevention: admitted within 4 days of cold exposure with acute frostbite injury
  • For treatment: admitted with clinically confirmed or suspected infected frostbite wound
Not Eligible

You will not qualify if you...

  • Pregnant patients
  • Prisoners
  • Expected death within 48 hours of admission
  • Unable to provide consent or have a representative provide consent
  • For prevention: patients admitted 5 or more days after frostbite injury
  • Patients with clinical infection at baseline for prevention aim
  • Allergy to aloe vera or silver dressings
  • For treatment: allergy to dalbavancin, vancomycin, or similar antibiotics
  • Infections caused by vancomycin-resistant Enterococcus
  • Stage IV or V chronic kidney disease or cirrhosis (Childs-Pugh C)
  • Expected death within 48 hours of infection
  • Anuria due to chronic kidney disease (CKD) for pharmacokinetic analysis aim

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Colorado Denver Anschutz Medical Campus

Aurora, Colorado, United States, 80045

Actively Recruiting

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Research Team

B

Blaire Balstad

CONTACT

T

Tracey MacDermott

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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