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Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study
Sponsor: Universität Luzern
Summary
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.
Official title: Prevention of Bacterial Contamination in Spinal Fusion Surgery Using Polyhexanide-Poloxamer Wound Irrigation - a Randomized Clinical Trial
Key Details
Gender
MALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
114
Start Date
2027-01-01
Completion Date
2028-12-31
Last Updated
2026-06-24
Healthy Volunteers
No
Interventions
Preventia Surgical Solution
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
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.
Locations (1)
Hirslanden Klinik St. Anna
Lucerne, Canton of Lucerne, Switzerland