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

Prevention of Bacterial Contamination in Spinal Fusion Surgery Using Polyhexanide-Poloxamer Wound Irrigation - a Randomized Clinical Trial

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spine Surgery; Surgical Site Infection (SSI); Surgical Site Infection Prevention
• Intervention / Treatment: Device: Preventia Surgical Solution; Device: 0.9 % NaCl

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 114
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Rami Sommerstein, Prof. Dr. Med.; Phone Number: +41 41 208 32 54; Email: rami.sommerstein@unilu.ch

Study Locations

• Switzerland
  • Canton of Lucerne
    • Lucerne, Canton of Lucerne, Switzerland, 6006
      • Hirslanden Klinik St. Anna
      • Contact: Ellinor Wyss; Phone Number: +41799004264; Email: ellinorwyss@hotmail.com
      • Sub-Investigator: Ellinor Wyss
      • Sub-Investigator: Oliver P Gautschi, Prof. Dr. med.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Preventia Surgical Solution; PREVENTIA® Surgical Irrigation is a CE-marked solution containing 0.1% polyhexanide (PHMB) and poloxamer, with proven antimicrobial and anti-biofilm activity.	Device: 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.
Sham Comparator: 0.9% NaCl Solution; Irrigation solution without intrinsic antimicrobial properties	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of bacterial growth	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.	Assessed 14 days postoperatively.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of bacterial growth	Presence of bacterial growth in each of the four individual swabs obtained around the surgical incision site.	Assessed 14 days postoperatively.
bacterial species and load	Semi-quantitative assessment of bacterial species and load, reported on an ordinal scale, for each of the four individual swabs	Assessed 14 days postoperatively
Surgical Site Infections	Wound healing assessment using the ASEPSIS wound scoring system.	on postoperative days 3-5 and for a substudy at 90 days (±15 days) and 12 months (±2 months) post-surgery

Collaborators and Investigators

• Sponsor: Universität Luzern

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 18, 2026
• First Submitted That Met QC Criteria: June 18, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 18, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: spinal surgery; surgical site infection; biofilm; SSI; infection prevention; spinal fusion surgery; preventia; polyhexanide; poloxamer; spondylodesis
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection
• Other Study ID Numbers: PROTECT-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No