Prevention of Bacterial Contamination in Spinal Fusion Surgery Using Polyhexanide-Poloxamer Wound Irrigation - a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 114
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Preventia Surgical Solution (Device)
0.9% NaCl Solution
Irrigation solution without intrinsic antimicrobial properties
干预措施: 0.9 % NaCl (Device)
结局指标
主要结局
未指定
次要结局
- Surgical Site Infections(on postoperative days 3-5 and for a substudy at 90 days (±15 days) and 12 months (±2 months) post-surgery)
研究者
Rami Sommerstein
Prof. Dr. med.
Universität Luzern
