← Back to Search

Antibiotic

Topical Antibiotics for Surgical Site Infection

Phase 3
Recruiting
Led By Robert V O'Toole, MD, MS
Research Sponsored by Major Extremity Trauma Research Consortium
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Any open type I, II, or IIIA fracture, regardless of timing of definitive treatment.
Patients ages 18 through 80 years.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 365 days of definitive fracture fixation surgery
Awards & highlights

Study Summary

This trial is testing whether a combination of Vancomycin and Tobramycin powders is better than just Vancomycin powder at reducing post-fixation infections of tibial plateau and tibial pilon fractures.

Who is the study for?
Adults aged 18-80 with high-risk tibial fractures initially treated with external fixation, who are now receiving plate and screw fixation. Ideal candidates have no severe allergies to Vancomycin or Tobramycin, are not pregnant, and can commit to follow-up appointments.Check my eligibility
What is being tested?
The TOBRA study is testing if a combination of Vancomycin and Tobramycin powders reduces infection rates post-surgery better than just Vancomycin powder in patients with certain high-risk leg fractures.See study design
What are the potential side effects?
Possible side effects include allergic reactions to the antibiotics used (Vancomycin or Tobramycin), which could manifest as skin rashes, difficulty breathing, or other hypersensitivity responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have an open fracture type I, II, or IIIA.
Select...
I am between 18 and 80 years old.
Select...
I was first treated with a brace or cast and had definitive treatment after 3 days once swelling went down.
Select...
My leg fracture was treated with surgery using plates and screws, and it's at a high risk of infection.
Select...
I have a broken shinbone with swelling and had surgery to relieve pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 365 days of definitive fracture fixation surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 365 days of definitive fracture fixation surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Deep Surgical Site Infection (SSI)
Secondary outcome measures
Antibiotic resistance
Sensitivity analyses

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment1 Intervention
Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed immediately before wound closure.
Group II: ControlActive Control1 Intervention
Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed immediately before wound closure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment group
2010
Completed Phase 4
~580

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
859 Previous Clinical Trials
223,731 Total Patients Enrolled
Major Extremity Trauma Research ConsortiumLead Sponsor
30 Previous Clinical Trials
25,126 Total Patients Enrolled
Robert V O'Toole, MD, MSPrincipal InvestigatorUniversity of Maryland, Department of Orthopaedic Trauma

Media Library

Tobramycin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT04597008 — Phase 3
Surgical Site Infection Research Study Groups: Control, Treatment
Surgical Site Infection Clinical Trial 2023: Tobramycin Highlights & Side Effects. Trial Name: NCT04597008 — Phase 3
Tobramycin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04597008 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants needed for this research project?

"This trial, which is currently seeking patients, was first posted on May 11, 2021 and was most recently updated on July 27, 2022."

Answered by AI

How can I sign up for the chance to be in this clinical trial?

"This study is looking for 1900 individuals that have had surgery for a wound infection and meet the following age, injury, and treatment criteria: 18-80 years old, tibia fracture with ipsilateral leg compartment syndrome and fasciotomy wounds that were initially treated with an external fixation, any open type I, II, or IIIA fracture, regardless of timing of definitive treatment."

Answered by AI

Our target age-group for this experiment are those 35 years or older - are we still looking for test subjects in this age-range?

"The parameters for inclusion in this trial state that patients must be aged 18-80. There are 210 other trials for patients that are minors and 663 for elderly patients."

Answered by AI

Are there any dangers associated with the use of this medication?

"Safety for the treatment group was estimated to be a 3. This is based off the fact that this is a phase 3 trial, which means that there is some data supporting efficacy as well as multiple rounds of data that support safety."

Answered by AI
~285 spots leftby Sep 2024