Surgical Site Infection (SSI)Phase 4PROTECT-SPINENCT07667036
Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study
A Phase 4 study testing Preventia Surgical Solution and 0.9 % NaCl in people with Surgical Site Infection (SSI) and Spine Surgery, run by Universität Luzern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Surgical Site Infection (SSI), Spine Surgery, Surgical Site Infection Prevention
- What is being tested?
- Preventia Surgical Solution and 0.9 % NaCl
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 114 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jan 2027to 31 Dec 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site
Hirslanden Klinik St. Anna
Lucerne, 6006
Ellinor Wyss, +41799004264, ellinorwyss@hotmail.com
Ellinor Wyss
About this study
Official title: 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.
Read the 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.
- Being tested
- Preventia Surgical Solution, 0.9 % NaCl
- Keywords
- SSI, surgical site infection, spinal surgery, spinal fusion surgery, preventia, polyhexanide, poloxamer, biofilm, infection prevention, spondylodesis
- Medical subject headings
- Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventia Surgical SolutionDevice
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 % NaClDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Preventia Surgical Solution |
| 0.9% NaCl Solution | Sham comparator | Irrigation solution without intrinsic antimicrobial properties Receives: Device: 0.9 % NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed 14 days postoperatively.
Secondary outcomes (3)
Presence of bacterial growth
Presence of bacterial growth in each of the four individual swabs obtained around the surgical incision site.
Measured: 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
Measured: Assessed 14 days postoperatively
Surgical Site Infections
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)
Measured: on postoperative days 3-5 and for a substudy at 90 days (±15 days) and 12 months (±2 months) post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jan 2027 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Site Infection (SSI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, open-label, randomized controlled study
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Luzern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rami Sommerstein, Universität Luzern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07667036
- Sponsor's protocol ID
- PROTECT-2025
- Acronym
- PROTECT-SPINE
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No