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Locally Applied Antibiotics for Infection Prophylaxis in Treatment of Open Fractures

NCT03705962 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-06-15

Study results available
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Summary

The primary objective of this study is to investigate the effectiveness of local antibiotic versus placebo in the prevention of infections in open fractures. The study will assess whether local treatment of open fractures with the antibiotic tobramycin (in addition to standard systemic antibiotics) will decrease the risk and rate of infection, and rate of re-operation. This will be studied using a randomized controlled clinical trial design in adult population of age 18-70 years who present with open fractures. About 133 subjects will be recruited in this study at UVA.

Conditions

  • Fractures, Open

Interventions

DRUG

Tobramycin

OTHER

Placebo: normal saline

Sponsors & Collaborators

  • University of Virginia

    lead OTHER

Principal Investigators

  • Seth Yarboro, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2019-03-07
Completion
2019-03-07

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 NCT03705962 on ClinicalTrials.gov