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Prevention and Treatment of Frostbite Infection With Antimicrobial Pharmacokinetic Analysis

NCT06266494 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-05-13

No results posted yet for this study

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.

Conditions

  • Frostbite

Interventions

DEVICE

Long-Acting silver dressings

Mepilex Transfer Ag

OTHER

Aloe Vera

Dermaid Aloe Vera

DRUG

Dalbavancin

1500mg IV dose

Sponsors & Collaborators

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Arek Wiktor, MD · University of Colorado Anschtuz

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2026-05-31
Completion
2026-08-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06266494 on ClinicalTrials.gov