Ceftazidime + Vancomycin for Surgical Site Infections

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Utah
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

The research team hypothesizes that ceftazidime, in conjunction with vancomycin, is a safe and effective way to prevent surgical site infections in lumbar spinal surgery.

Objective 1: Evaluate the drain and serum concentrations of ceftazidime + vancomycin from 0-3 days postoperative. Hypothesis: The investigators hypothesize that intrawound ceftazidime will remain concentrated at the wound site, and there will be minimal absorption of ceftazidime into the circulatory system.

Objective 2: Evaluate incidence of surgical site infections (within 90 days postoperative) and pseudoarthrosis (within 2 years postoperative) after the use of ceftazidime in addition to vancomycin. Hypothesis: The investigators hypothesize that intrawound ceftazidime, in conjunction with intrawound vancomycin, is a safe and effective way to reduce surgical site infections following lumbar spine surgery, while having little effect on construct fusion (e.g., pseudoarthrosis).

Objective 3: Evaluate ceftazidime concentration effects on osteoblasts, specifically metabolic activity and osteogenic protein expression profiles. Hypothesis: The investigators hypothesize that ceftazidime concentrations measured from drain samples will not have an effect on metabolic activity and osteogenic protein expression of osteoblasts.

Who Is on the Research Team?

BK

Brian Karamian, MD

Principal Investigator

University of Utah Orthpaedic Center

Are You a Good Fit for This Trial?

This trial is for people undergoing lumbar spine fusion surgery. It does not specify detailed inclusion or exclusion criteria, but participants are likely adults scheduled for this type of back surgery.

Inclusion Criteria

I am having thoracolumbar spinal fusion surgery on 10 or fewer levels at the University of Utah.
I am 18 years old or older.

Exclusion Criteria

I have not had spine surgery by University of Utah orthopedic spine doctors.
I am younger than 18 years old.
Patient has allergies to vancomycin, ceftazidime or aztreonam, or severe allergies to any cephalosporin
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What Are the Treatments Tested in This Trial?

Interventions

  • Ceftazidime
  • Vancomycin

Trial Overview

The study tests whether applying the antibiotics ceftazidime and vancomycin directly to the surgical site can safely prevent infections after lumbar spinal fusion. Researchers will monitor drug levels and infection rates after surgery.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Intrawound antibioticsExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials
1,169
Recruited
1,623,000+