Using Irrisept Solution to Prevent Infections After Spine Surgery
Impact of Prophylactic Use of Irrisept Irrigation System for Spinal Instrumentation
NA · Rhode Island Hospital · NCT06439953
This study is testing if using Irrisept instead of regular saline can help prevent infections after spine surgery for adults with different spinal conditions.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rhode Island Hospital (other) |
| Locations | 1 site (Providence, Rhode Island) |
| Trial ID | NCT06439953 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of Irrisept, a broad-spectrum antiseptic, for wound irrigation in patients undergoing spinal instrumentation surgery. The study aims to reduce post-operative complications such as surgical site infections and seroma formation by utilizing Irrisept instead of traditional saline mixed with vancomycin. By terminally sterilizing the wound bed and prosthetic devices, the trial seeks to minimize bacterial colonization and biofilm formation, which are common precursors to infection. Eligible participants include adults with various spinal conditions who are undergoing standard surgical procedures.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older undergoing spinal surgery for deformity, oncologic, degenerative, or traumatic conditions.
Not a fit: Patients with acute or chronic open wounds, ongoing infections, or allergies to vancomycin or chlorhexidine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of infections and complications following spinal surgery, leading to better patient outcomes.
How similar studies have performed: While the use of antiseptic solutions in surgical settings is common, the specific application of Irrisept in spinal surgery is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18+ years old * Indications: deformity, oncologic, degenerative, trauma * Standard layer-by-layer closure * Locoregional flap-based closure Exclusion Criteria: * 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
Where this trial is running
Providence, Rhode Island
- Rhode Island Hospital — Providence, Rhode Island, United States (RECRUITING)
Study contacts
- Principal investigator: Jared S. Fridley, MD — Rhode Island Hospital
- Study coordinator: Alexander Chernysh
- Email: AChernysh@lifespan.org
- Phone: 401-444-9868
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Post-Op Complication, Spine Surgery, Site Infection, Surgical Site Infection, Spinal Instrumentation, Index Spinal Instrumentation, Layer-by-Layer Closure, Locoregional Flap-Based Closure