A Prospective Clinical Observation of Ventriculo-Peritoneal Shunt in Patients With Normal or Low Hydrocephalus and A Multi-Center Randomized Controlled Study on Application of "Three-step Disinfection" in Reducing the Incidence of Post-operative Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Rate of postoperation Intracranial infection
研究概览
简要总结
A randomized, single blind, parallel controlled, multicenter clinical study was performed in which patients who had undergone a cerebrospinal fluid to peritoneal shunt that met the criteria were divided into two groups (test and control) in a 1:1 ratio, with the test group applied disinfection by the "three-step sterilization method" and completed the procedure, and the control group underwent the same surgical procedure according to the routine aseptic disinfection procedure, relevant literatures were reviewed and the previous ones in our hospital were summarized, it is intended to conduct a one-year clinical observation of the two groups, to compare the perioperative and long-term infection incidence of the two groups and evaluate them comprehensively, to evaluate whether the "three-step sterilization method" disinfected patients have reduced perioperative and long term infection risk after surgery compared with previous surgery with routine disinfection procedure, and to evaluate their effectiveness.
详细描述
Data Collection:
Preoperative symptoms and signs, medical records, imaging data, preoperative functional scores (Glasgow score, ADL score, jnphgsr score) were collected.
Data Security Monitoring:
- Follow-up after surgery according to the study scheme, and comprehensive collection of safety data, for key patient researchers should focus on, in order to comprehensively and early detection of all kinds of adverse events.
- All adverse events are well documented, properly handled and tracked until they are properly resolved or stable, and serious and unexpected events are reported to the ethics committee, competent authorities, applicants and pharmaceutical supervisory and administrative departments in a timely manner as required;
- Major investigators regularly conduct cumulative reviews of all adverse events and, if necessary, hold researcher meetings to assess the risks and benefits of the study;
Data Preservation:
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18, regardless of gender.
- •Patients with hydrocephalus of high, normal and low pressure caused by various reasons need V-P shunt and meet the operation indications.
- •Before the start of the trial, a written informed consent signed by the subject himself or his legal representative must be obtained.
排除标准
- •Patients who had participated in clinical trials of other drugs or medical devices within 6 months.
- •Patients with abnormal coagulation mechanisms or who had received treatment with thrombolytic agents, anticoagulants, or inhibitors of platelet coagulation within 2 weeks, and patients with hemophilia.
- •Patients with severe diseases of other systems, such as severe diseases of the hematological, respiratory, digestive, and urinary systems, were combined.
- •Patients with co-existing infectious diseases.
- •Pregnant, lactating female patient.
- •Physicians judged other situations in which they could not participate in the trial.
- •The subjects themselves or their legal surrogates refused to participate in the clinical trial.
结局指标
主要结局
Rate of postoperation Intracranial infection
时间窗: 10 days post-operation to 12 month post-operation
post-operation intracranial infection(diagnosed by lumbar puncture)
Rate of postoperation Intra-abdominal infection
时间窗: 10 days post-operation to 12 month post-operation
Post-operation abdominal-cavity infection(diagnosed by WBC counting and clinical feature)
次要结局
- Rate of Ventriculoperitoneal shunt malfunction(10 days post-operation to 12 month post-operation)
- Rate of postoperation Surgical wound infection(10 days post-operation to 12 month post-operation)
研究者
Baiyun Liu
Professor, Chief Physician
Beijing Tiantan Hospital