Acute Application of Antibiotic Powder in Open Fracture Wounds

NCT04872400 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-03-06

Study results available
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Summary

The purpose of this study is to help determine the best treatment for severe injures like open fracture wounds.

Some broken bone injuries can be more likely to get an infection. It is mostly due to the way they were injured. Surgical site infection in the orthopedic surgery population is a big public health issue. Wound infections result in both longer length of hospital stay and total cost of care. This study will be using an antibiotic called Vancomycin or Tobramycin in a powder form.

Conditions

  • Fractures, Open
  • Wounds and Injuries--Infections
  • Anti-Bacterial Agents
  • Fractures, Bone
  • Extremity Fracture Lower
  • Extremity Fractures Upper

Interventions

DRUG

Vancomycin

1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.

DRUG

Tobramycin

1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury.

Sponsors & Collaborators

  • Denver Health and Hospital Authority

    collaborator OTHER
  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Nicholas Alfonso, MD · University of Colorado, Denver

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-14
Primary Completion
2023-09-30
Completion
2023-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT04872400 on ClinicalTrials.gov