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Powdered Intrawound Vancomycin in Open Fractures Trial

NCT06504992 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2024-09-19

No results posted yet for this study

Summary

The purpose of this randomized control trial is to compare the rate of post-operative infection in patients with open fractures in upper or lower extremity long bones randomized to receive intra-operative intrawound topical vancomycin powder on their open fractures in addition to the current best practice of intravenous antibiotics with irrigation and debridement compared to intravenous antibiotics with irrigation and debridement alone during definitive operative fixation of the fracture.

Conditions

  • Open Fracture
  • Trauma
  • Infection, Surgical Site
  • Fractures, Open
  • Wound Infection
  • Fractures, Bone
  • Post-Operative Wound Infection

Interventions

DRUG

Vancomycin 1000 MG

Powdered, intrawound vancomycin 1000 mg at the time of definitive surgery for open fracture fixation in addition to the current best practice of intravenous antibiotics with irrigation and debridement

Sponsors & Collaborators

  • Health Sciences Centre, Winnipeg, Manitoba

    collaborator OTHER

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Gabriel Larose, MD, MSc, FRCSC · University of Manitoba

  • Madison Price, MD · University of Manitoba

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-01
Primary Completion
2028-09-01
Completion
2029-09-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT06504992 on ClinicalTrials.gov