Irrisept Solution for Instrumented Spine Surgery

This study is looking at ways to prevent infections after spine surgery that uses hardware (spinal instrumentation). Researchers are comparing two different irrigation solutions used during surgery: Irrisept (a chlorhexidine gluconate solution) alone, or a solution of vancomycin-saline, which may or may not include topical vancomycin. The goal is to see which method is better at preventing surgical site infections (infections at the surgery site) within 90 days after your operation. This study is for adults aged 18 and older who are having spine surgery for conditions like deformity, cancer, degenerative issues, or trauma. You cannot join if you have open wounds, another infection, or are currently taking antibiotics for an infection. The study is currently unclear on its recruitment status.

Study design
This interventional study plans to enroll 200 participants. It compares two different irrigation solutions used during spine surgery.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 90 days after their surgery to check for surgical site infections.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06439953

Irrisept Solution for Instrumented Spine Surgery

Recruiting
NAAges 18+InterventionalPrevention
Rhode Island Hospital
~200 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Chlorhexidine gluconate solutionVancomycin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of surgical site infection
Measured over 90 days post-operatively
Post-Op Complication
Spine Surgery
Site Infection
Surgical Site Infection
Spinal Instrumentation
Index Spinal Instrumentation
Layer-by-Layer Closure
Locoregional Flap-Based Closure
1 sites across 1 states
Rhode Island1
  • Jared S. Fridley, MD · PRINCIPAL_INVESTIGATOR · Rhode Island Hospital
  • Albert S. Woo, MD · PRINCIPAL_INVESTIGATOR · Rhode Island Hospital

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Eligibility criteria

Inclusion

Age: 18+ years old
Indications: deformity, oncologic, degenerative, trauma
Standard layer-by-layer closure
Locoregional flap-based closure

Exclusion

Acute/chronic open wounds (spine or non-spine)
On-going non-spinal infection within 30 days of index operation
Concurrent antibiotic use (for spine or non-spine infections)
History of prior spinal infection
Allergy to vancomycin or chlorhexidine
Suspicion for osteomyelitis
Other surgery within 90 days post-operatively fromm index
Concurrent enrollment in other trial
  • Occurrence of surgical site infection90 days post-operatively

    Development of infection after index spinal instrumentation