ClinicalTrials.gg
Enrolling by invitationNCT07934199Updated Nov 12, 2026

Ceftazidime Safety and Efficacy in the Prevention of Surgical Site Infections

A Phase 2 interventional study of Topical ceftazidime and vancomycin in Thoracolumbar Spinal Fusion, sponsored by University of Utah. Enrolling by invitation at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-11-12.

Sponsored by University of Utah · Phase 2, Interventional, and Prevention

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Jul 2026, registered Nov 2026).
Updated Nov 12, 2026Newly registeredGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 202 studies in Surgical Wound Infection with a site in United States — 31 open to participants now, 34 under way, 4 of them phase 3. Surgical Wound Infection · United States.

Planned enrollment
122nd of 177
80 · median 208
Started
2026
with 6 others
Phase 2
9 of 202
1 open now
Primary completion
2030-07
later than 32 of 33 live
Registered
202nd of 202
by date

Among the 202 studies in Surgical Wound Infection with a site in United States, this one is the 122nd largest by planned enrollment of the 177 interventional ones that give a count, is one of 7 that started in 2026, is one of 9 in phase 2, reaches primary completion later than 32 of the 33 other live ones, and was the 202nd registered.

Surgical Wound Infection

745 studies on the registry are indexed under Surgical Wound Infection; 151 are open to participants now.

Browse Surgical Wound Infection studies →

Open to participants now

31 of the 202 studies in Surgical Wound Infection with a site in United States are open now. Recruiting first, the newest first:

25 more — sign in →

All 31 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 84 Surgical Wound Infection studies recruiting now, 60 (71%) set no upper age limit and 16 (19%) stop at 75 or younger; 12 take children under 18; 14 take healthy volunteers.

This study: 18 Years to 80 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 202 studies in Surgical Wound Infection with a site in United States, or all of them as a file.
02

Study summary

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.

Read the detailed description

Surgical site infections (SSI) present a challenge in orthopedic spine surgery and can cause significant morbidity and mortality, as well as increased healthcare costs. Reported incidence of spine SSI varies from 1-14%, with primary lumbar fusions at 8.8% and revision lumbar fusions at 12.2%. Current practices to prevent SSIs include the use of topical antibiotics, particularly vancomycin, in addition to standard intra-operational IV antibiotics.

However, previous studies show conflicting evidence regarding the efficacy of topical vancomycin in the prevention of SSIs. As such, there is no clear guidance on the use of topical antibiotics in the prevention of SSIs, and the US FDA has not approved local application of vancomycin for this purpose.

In addition, there are several adverse effects that may result from the use of local vancomycin. With frequent vancomycin use, causal organisms of SSIs are shifting towards gram negative pathogens rather than MSSA and MRSA, which have historically been the predominant cause of SSIs in orthopedics. Local use of vancomycin also increases the risk of nonunion and pseudarthrosis, as vancomycin inhibits the migration potential of osteoblasts, which may result in the interference of bone remodeling.

With no clear recommendation of the use of local vancomycin, as well as the trend towards gram-negative pathogens, there is a need to investigate the efficacy of other topical antibiotics for the prevention of SSIs. Ceftazidime is a broad-spectrum third generation cephalosporin, with mainly gram-negative coverage. This study aims to evaluate the safety and efficacy of ceftazidime, in conjunction with vancomycin, in post-operative prophylaxis of SSI following lumbar spine instrumentation.

03

Conditions studied

  • Thoracolumbar Spinal Fusion

Keywords

  • Thoracolumbar Spinal Surgery
  • Ceftazidime
  • Vancomycin
  • Surgical Site Infections
  • Safety
  • Efficacy
  • Prevention
04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patient age greater than or equal to 18 at time of surgery .
  • Patient undergoing thoracolumbar spinal fusion of less than or equal to 10 surgical levels by orthopedic spine faculty at the University of Utah.

Exclusion criteria

Exclusion Criteria:

  • Patient age less than 18 at time of surgery.
  • Patient not operated on at the University of Utah by orthopedic spine faculty .
  • Patient treated nonoperatively only .
  • Patient treated operatively, but with over 10 spinal levels fused.
  • Patient treated by the University of Utah orthopedic spine faculty, but not undergoing thoracolumbar fusion procedure.
  • Patient has allergies to vancomycin, ceftazidime or aztreonam, or severe allergies to any cephalosporin.
  • Patient has kidney problems, severe renal impairment ( \<30 mL/min), is pregnant or breastfeeding, or is .
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Intrawound antibiotics

    Topical ceftazidime and vancomycin after lumbar spinal fusion surgery

    Drug: Topical ceftazidime and vancomycin

Interventions

  • DrugTopical ceftazidime and vancomycin

    1g:1g ratio of topical ceftazidime and vancomycin after lumbar spinal fusion surgery.

    Also known as: Ceftazidime - Fortaz, Tazicef, Ceptaz, Zacicefta, Vancomycin - Vancocin, Firvanq, Tyzavan

06

What researchers measure

Primary outcomes

  1. Infections

    Incidence of surgical site infections

    Time frame: 90 days postoperative

07

Study locations

1 site
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2026 (actual). Primary completion is estimated for Jul 2030, 48 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 6, 2026
First posted
Nov 12, 2026
StartActual
Jul 7, 2026
Primary completionEst.
Jul 2030
CompletionEst.
Jul 2030
Last update
Nov 12, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 12, 2026
Show all 1 update
  1. Nov 12, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07934199
Lead sponsor
University of Utah
Responsible party
Brian Karamian (Principle Investigator, University of Utah) — Principal investigator
First posted
Nov 12, 2026
Start date
Jul 7, 2026
Primary completion
Jul 2030 (estimated)
Completion
Jul 2030 (estimated)
Last update
Nov 12, 2026

Study contacts

Brian Karamian, MD
principal investigator · University of Utah Orthpaedic Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

No contact was published for this record. The registry link below has the sponsor’s details.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion