Using Irrisept Solution to Prevent Infections After Spine Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.