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

Surgical wound infections are among the possible complications following spinal surgery. There is a particularly increased risk of such infections in operations in which implants, such as screws or rods to stabilize the spine, are used. One reason for these infections is that many different bacteria live on human skin. These are found not only on the surface of the skin, but also in deeper layers of the skin, for example in hair follicles and sebaceous glands. In these areas, they cannot always be fully reached by conventional disinfectants before surgery. As a result, bacteria can enter the surgical site despite careful preparation. This study investigates a special irrigation solution called PREVENTIA®. It contains active substances, polyhexanide and poloxamer, which can kill bacteria and attack so-called biofilms. A biofilm is a type of protective layer that bacteria form on implants. Within this layer, the bacteria are better protected and can cause infections that are more difficult to treat. Until now, this solution has mainly been used for irrigating superficial wounds. However, it has not yet been investigated whether irrigating deeper tissue layers during spinal surgery can reduce the presence of bacteria. This study therefore aims to investigate: whether irrigating the surgical wound with PREVENTIA® results in fewer detectable bacteria in the surgical site, and whether this method may potentially help to reduce infections in the surgical site.

• Preventia Surgical Solution (Device): Irrigation of the surgical wound with 0.1% polyhexanide and poloxamer and instillation for 1 minute instilled with the amount needed to fill up to the wound border before and after placement of the pedicle screws and before opening of the spinal canal (to guarantee no contact with the dura mater). This procedure is followed by complete aspiration of the fluid.
• 0.9 % NaCl (Device): Irrigation of the surgical wound with 0.9% NaCl and instillation for 1 minute instilled with the amount needed to fill up to the wound border before and after placement of the pedicle screws and before opening of the spinal canal (to guarantee no contact with the dura mater). This procedure is followed by complete aspiration of the fluid.

Primary outcomes

• Presence of bacterial growth [Assessed 14 days postoperatively.]: Presence of bacterial growth in at least one of four intraoperative swabs (deep wound swab 1 or 2, retractor swab, or surgical glove swab) obtained around the surgical incision site.

Secondary outcomes

• Presence of bacterial growth [Assessed 14 days postoperatively.]: Presence of bacterial growth in each of the four individual swabs obtained around the surgical incision site.
• bacterial species and load [Assessed 14 days postoperatively]: Semi-quantitative assessment of bacterial species and load, reported on an ordinal scale, for each of the four individual swabs
• Surgical Site Infections [on postoperative days 3-5 and for a substudy at 90 days (±15 days) and 12 months (±2 months) post-surgery]: Wound healing assessment using the ASEPSIS wound scoring system. ASEPSIS stands for: * Additional treatment * Serous discharge * Erythema * Purulent exudate * Separation of deep tissues * Isolation of bacteria * Stay as inpatient prolonged over 14 days Minimum Value: 0 Maximum Value: 70 Outcome: Higher scores mean a worse outcome (greater infection severity)

Sex: Male, ages: 18 Years to any

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