Irrisept Solution for Instrumented Spine Surgery

Launched by RHODE ISLAND HOSPITAL · May 28, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the use of a special solution called Irrisept in patients undergoing spine surgery. The goal is to see if Irrisept can help prevent infections at the surgery site more effectively than traditional methods, which usually involve rinsing the area with a saline solution mixed with an antibiotic called vancomycin. This trial aims to reduce the risk of deep infections while avoiding complications like seromas, which are fluid-filled sacs that can form after surgery.

To participate in the trial, you need to be at least 18 years old and scheduled for standard spine surgery for reasons like deformities, cancer, or trauma. However, if you have current open wounds, ongoing infections, or allergies to certain medications, you may not be eligible. Participants in the study will receive the Irrisept solution during their surgery and will be monitored for any signs of infection or complications afterward. Overall, this trial seeks to improve outcomes for patients undergoing spinal procedures.

Gender

ALL

Eligibility 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

Trial Officials