Investigation of the PREVENTIA® Irrigation Solution for Reducing Bacteria in Spinal Surgery With Implants - A Comparative Study (PROTECT-SPINE)
2026年6月24日 更新者：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.
研究概览
详细说明
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.
研究类型
介入性
注册 (估计的)
114
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Rami Sommerstein, Prof. Dr. Med.
- 电话号码：+41 41 208 32 54
- 邮箱：rami.sommerstein@unilu.ch
学习地点
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Lucerne、瑞士、6006
- Hirslanden Klinik St. Anna
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接触：
- Ellinor Wyss
- 电话号码：+41799004264
- 邮箱：ellinorwyss@hotmail.com
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副研究员：
- Ellinor Wyss
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副研究员：
- Oliver P Gautschi, Prof. Dr. med.
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：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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假比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Presence of bacterial growth
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Presence of bacterial growth
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2027年1月1日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年6月18日
首先提交符合 QC 标准的
2026年6月18日
首次发布 (实际的)
2026年6月24日
研究记录更新
最后更新发布 (实际的)
2026年6月29日
上次提交的符合 QC 标准的更新
2026年6月24日
最后验证
2026年6月1日
更多信息
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