Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study (PROTECT-SPINE)
24. juni 2026 opdateret af: Rami Sommerstein, Universität Luzern
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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
114
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Rami Sommerstein, Prof. Dr. Med.
- Telefonnummer: +41 41 208 32 54
- E-mail: rami.sommerstein@unilu.ch
Studiesteder
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Lucerne, Schweiz, 6006
- Hirslanden Klinik St. Anna
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Kontakt:
- Ellinor Wyss
- Telefonnummer: +41799004264
- E-mail: ellinorwyss@hotmail.com
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Underforsker:
- Ellinor Wyss
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Underforsker:
- Oliver P Gautschi, Prof. Dr. med.
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
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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.
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Sham-komparator: 0.9% NaCl Solution
Irrigation solution without intrinsic antimicrobial properties
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Presence of bacterial growth
Tidsramme: Assessed 14 days postoperatively.
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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.
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Assessed 14 days postoperatively.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Presence of bacterial growth
Tidsramme: Assessed 14 days postoperatively.
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Presence of bacterial growth in each of the four individual swabs obtained around the surgical incision site.
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Assessed 14 days postoperatively.
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bacterial species and load
Tidsramme: Assessed 14 days postoperatively
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Semi-quantitative assessment of bacterial species and load, reported on an ordinal scale, for each of the four individual swabs
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Assessed 14 days postoperatively
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Surgical Site Infections
Tidsramme: on postoperative days 3-5 and for a substudy at 90 days (±15 days) and 12 months (±2 months) post-surgery
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Wound healing assessment using the ASEPSIS wound scoring system. ASEPSIS stands for:
Minimum Value: 0 Maximum Value: 70 Outcome: Higher scores mean a worse outcome (greater infection severity) |
on postoperative days 3-5 and for a substudy at 90 days (±15 days) and 12 months (±2 months) post-surgery
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. januar 2027
Primær færdiggørelse (Anslået)
31. december 2027
Studieafslutning (Anslået)
31. december 2028
Datoer for studieregistrering
Først indsendt
18. juni 2026
Først indsendt, der opfyldte QC-kriterier
18. juni 2026
Først opslået (Faktiske)
24. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
29. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- PROTECT-2025
Plan for individuelle deltagerdata (IPD)
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