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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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.
• Устройство 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.

Первичные конечные точки

• Presence of bacterial growth [Срок оценки: Assessed 14 days postoperatively.]

Вторичные конечные точки (3)

• Presence of bacterial growth [Срок оценки: Assessed 14 days postoperatively.]
• bacterial species and load [Срок оценки: Assessed 14 days postoperatively]
• Surgical Site Infections [Срок оценки: on postoperative days 3-5 and for a substudy at 90 days (±15 days) and 12 months (±2 months) post-surgery]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Швейцария · 1 центр

• Hirslanden Klinik St. Anna — Lucerne

Идентификаторы

NCT: NCT07667036 · PROTECT-2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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