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Topical Antibiotics for Surgical Site Infection
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I have an open fracture type I, II, or IIIA.I am between 18 and 80 years old.I am allergic to Tobramycin or similar antibiotics.I was first treated with a brace or cast and had definitive treatment after 3 days once swelling went down.You have not received the study medication before.My injury has been surgically treated before joining the study.I have severe muscle damage in my leg due to increased pressure.My leg fracture was treated with surgery using plates and screws, and it's at a high risk of infection.I have a broken shinbone with swelling and had surgery to relieve pressure.
- Group 1: Control
- Group 2: Treatment
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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