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

NCT07667036 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: PROTECT-2025
• Study Type: interventional
• Target: 114
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Surgical Site Infection (SSI); Spine Surgery; Surgical Site Infection Prevention

Keywords

SSI; surgical site infection; spinal surgery; spinal fusion surgery; preventia; polyhexanide; poloxamer; biofilm; infection prevention; spondylodesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Presence of bacterial growth

  Assessed 14 days postoperatively.

• bacterial species and load

  Assessed 14 days postoperatively

• Surgical Site Infections

  on postoperative days 3-5 and for a substudy at 90 days (±15 days) and 12 months (±2 months) post-surgery

Study Arms (2)

Preventia Surgical Solution

EXPERIMENTAL

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

0.9% NaCl Solution

SHAM COMPARATOR

Irrigation solution without intrinsic antimicrobial properties

Device: 0.9 % NaCl

Interventions

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.

Preventia Surgical Solution

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.

0.9% NaCl Solution

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universität Luzern: lead

Study Sites (1)

Hirslanden Klinik St. Anna

Lucerne, 6006, Switzerland

Location

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rami Sommerstein, Prof. Dr. Med.

CONTACT

+41 41 208 32 54; rami.sommerstein@unilu.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Single-center, open-label, randomized controlled study

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)