Study of Irrisept versus Vancomycin-Saline Irrigation to Prevent Infections and Complications After Spinal Instrument Surgery

What this Trial Is About

Researchers are investigating the use of different irrigation methods during spinal instrumentation surgery, which is commonly performed to treat traumatic, oncologic, and degenerative spinal conditions. The study evaluates whether using Irrisept, a chlorhexidine gluconate solution, can reduce post-operative complications such as surgical site infections, seromas, and wound breakdown compared to the standard vancomycin-saline irrigation, which sometimes increases the risk of seroma formation. This trial is a prospective, randomized controlled study conducted on adults undergoing posterior spinal instrumentation for various indications. Participants will be randomly assigned to receive either Irrisept irrigation or vancomycin-saline irrigation with or without topical vancomycin powder during their spinal surgery. Irrisept is administered through a low-pressure lavage system and has been effective as a bactericidal agent in other orthopedic procedures. The standard care group receives vancomycin-saline irrigation, which targets gram-positive bacteria but may not be as effective against gram-negative organisms and may increase seroma risk. During the study, patients will be monitored for surgical site infections up to 90 days after surgery, along with other complications like wound dehiscence, hospital readmission, and atypical infections for up to 12 months. Researchers will also track length of hospital stay, mortality, drain removal time, and overall cost of care. The trial aims to gather comprehensive data on post-operative outcomes and safety, with follow-up visits and evaluations throughout one year after surgery.

Irrisept Solution for Instrumented Spine Surgery