MedTrace Logo

Noninferiority Comparison of Prophylactic Open Fracture Antimicrobial Regimens

NCT03560232 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2020-09-11

No results posted yet for this study

Summary

To demonstrate noninferiority of three different empiric antimicrobial regimens compared to the traditional antimicrobial regimen for the management of grade III open fractures as well as evaluate outcomes among these groups.

Conditions

  • Open Fracture
  • Post-Op Wound Infection

Interventions

DRUG

Ceftriaxone

See arm description

DRUG

Ampicillin/sulbactam

See arm description

DRUG

Piperacillin/tazobactam

See arm description

DRUG

Cefazolin + Gentamicin

See arm description

DRUG

Clindamycin + Gentamicin

See arm description

Sponsors & Collaborators

  • Mercy Health Ohio

    lead OTHER

Principal Investigators

  • Natalie I Rine, PharmD · MercyHealth Youngstown

  • Paul T Miller, PharmD · MercyHealth Youngstown

  • Tyson T Schrickel, MD · MercyHealth Youngstown

  • Stuart Drew, DO · MercyHealth Youngstown

  • David J Gemmel, PhD · MercyHealth Youngstown

  • Chad W Donley, MD · MercyHealth Youngstown

  • Allison R Lauver, PharmD · MercyHealth Youngstown

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-09
Primary Completion
2020-02-19
Completion
2020-02-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03560232 on ClinicalTrials.gov