Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study

Spinal surgery carries a risk of surgical wound infections (i.e., the entry of bacteria). Despite various preventive measures, such infections continue to occur, particularly in operations involving implants. In this study, we would like to investigate whether rinsing the surgical wound with a special irrigation solution called PREVENTIA® can reduce the number of bacteria in the wound during the operation.

Inclusion Criteria: * Age more than 18 years * Plan to undergo elective spinal fusion surgery (including thoracic and lumbar vertebrae, and sacrum and coccyx) * Informed consent as documented by signature Exclusion Criteria: * Emergency spine surgery * Previous spine fusion surgery * Unable to follow the comply with the study procedure or provide informed consent * Known allergies to any of the products used in the trial * Female gender * Current or recent (last 14 days) antibiotic therapy * Participation in another trial with an antimicrobial substance within the 30 days preceding and during the present trial * Known or suspected drug or alcohol abuse * Inability to follow the procedures of the investigation, e.g. due to language problems, psychological disorders, dementia, etc. of the subject * Evidence or suspicion of preexisting infection, defined as: Current local infection (or active treatment) involving the spine or adjacent soft tissues (e.g. spondylodiscitis, epidural or paravertebral abscess, cellulitis at the intervention site) diagnosed clinically or by imaging prior to intervention; Active systemic bacterial/fungal infection requiring antimicrobial therapy