Treatment group for Surgical Site Infection

University of Maryland Shock Trauma Center, Baltimore, MD
Surgical Site InfectionTreatment group - Drug
Eligibility
18 - 80
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Post-operative Surgical Site Infections

Treatment Effectiveness

Phase-Based Effectiveness

2 of 3
Phase 3
This is further along than 85% of similar trials

Similar Trials

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Group #4: VerTouch utilized for identification of site for lumbar puncture procedure
1
Cohort A
2
Vancomycin and Tobramycin

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: within 365 days of definitive fracture fixation surgery

Day 365
Antibiotic resistance
Deep Surgical Site Infection (SSI)
Sensitivity analyses

Trial Safety

Phase-Based Safety

3 of 3
This is further along than 85% of similar trials

Similar Trials

1
Group #4: VerTouch utilized for identification of site for lumbar puncture procedure
2
Cohort A
3
Vancomycin and Tobramycin

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

Control
1 of 2
Treatment
1 of 2

Active Control

Experimental Treatment

1900 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment group · No Placebo Group · Phase 3

Treatment
Drug
Experimental Group · 1 Intervention: Treatment group · Intervention Types: Drug
Control
Drug
ActiveComparator Group · 1 Intervention: Control group · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Treatment group
2010
Completed Phase 4
~580

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: within 365 days of definitive fracture fixation surgery

Who is running the clinical trial?

Major Extremity Trauma Research ConsortiumLead Sponsor
29 Previous Clinical Trials
24,926 Total Patients Enrolled
Anthony R Carlini, MSStudy DirectorJohns Hopkins Bloomberg School of Public Health
1 Previous Clinical Trials
1,200 Total Patients Enrolled
Renan C Castillo, PhDPrincipal InvestigatorJohns Hopkins Bloomberg School of Public Health
2 Previous Clinical Trials
1,380 Total Patients Enrolled
Robert V O'Toole, MD, MSPrincipal InvestigatorUniversity of Maryland, Department of Orthopaedic Trauma

Eligibility Criteria

Age 18 - 80 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a fracture in your shin bone that is causing pressure buildup in your leg muscles, requiring surgery to release the pressure.
You have a broken bone that is still healing or has not been treated yet.
You had surgery to fix a fracture in your tibia using a plate and screws. You also have a higher risk of getting an infection because of other health factors.
References

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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