A Registry for Comparing Catheter-Related Infection Rates Among Various Shunt Systems in the Treatment of Hydrocephalus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 433
- 试验地点
- 8
- 主要终点
- Number of Subjects With Shunt Infections
研究概览
简要总结
The purpose of this Registry is to compare shunt/catheter-related infection rates among various shunt systems when used according to hospital standard of care to treat hydrocephalus.
详细描述
Clinical trials show that the majority of infections in shunt systems originate from bacterial contamination introduced at the time of surgery and most appear by 3-4 weeks post-operatively. Protection must persist well beyond the surgical procedure to make certain that all contaminating bacteria are completely eradicated.
Depending upon the institution, shunt infection rates have been known to be as little as 1% to as much as 25%. However, two prospective trials that have been published from large databases, with a consistent definition of infection, have indicated an overall infection rate of approximately 10%
This prospective non-randomized, open-label Registry is designed to investigate and identify short-term shunt/catheter-related infection rates in ventriculoperitoneal shunt systems using various catheters during hospital standard of care treatment of Subjects with hydrocephalus. Prospective Subjects will include those receiving shunts for the first time (de novo) and those with previously implanted shunts for whom catheter or total system replacements are required.
This Registry will enroll 450 implanted Subjects of any age who meet all the inclusion criteria and none of the exclusion criteria and who provide signed Informed Consent to participate in this clinical Registry
Subjects will be followed for up to 90 days.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The Subject requires a surgical procedure to implant (de novo) a ventriculoperitoneal shunt or to replace an already implanted shunt catheter for the treatment of hydrocephalus.
- •The Subject (family member/legal representative) has completed the Informed Consent process prior to enrollment into this Registry.
- •The Subject (family member/legal representative) is willing to comply with the Registry protocol timelines & requirements.
排除标准
- •The Subject's planned shunt has distal drainage to the heart.
- •The Subject has an active infection of the indwelling shunt system, cerebrospinal fluid or abdominal cavity.
- •The Subject has ventriculitis, peritonitis or meningitis.
- •The Subject has sepsis.
- •The Subject has a history of poor wound healing.
- •The Subject has symptoms pertaining to: a skin infection at or near the site of any incisions; an ear infection on either side; a respiratory tract infection; or a urinary tract infection that, in the Investigator's opinion is clinically significant and might compromise the outcome of this Registry.
- •The Subject has had any form of bowel surgery 30 days prior to device implant or anticipates bowel surgery within 90 days following device implant
- •The Subject has loculation(s) within the ventricular system.
- •The Subject is otherwise determined by the Investigator to be medically unsuitable for participation in this Registry.
- •The Subject is currently enrolled in another drug or device trial or has been previously entered in this trial.
- •The Subject exhibits other difficulties, which would preclude follow-up for 90 days.
- •The Subject is a prisoner.
结局指标
主要结局
Number of Subjects With Shunt Infections
时间窗: Implantation to Explant
Number of shunt infections occurring in subjects implanted with antibiotic impregnated catheters and standard catheters.
次要结局
- Non-infectious Antibiotic Impregnated (AI) and Standard Catheter Subjects With Shunt Failures(April 2008)