To Determine the Efficacy of Irrisept in Reducing Urinary Tract Infection During Urethral Catheter Removal.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Urinary tract infection
研究概览
简要总结
Given the high burden of post-catheter removal UTIs, this study aims to evaluate Irrisept instillation as a non-antibiotic intervention to reduce infection rates. By comparing Irrisept to saline irrigation, the study will provide critical insights into the efficacy of antiseptic bladder irrigation in preventing UTIs while minimizing antibiotic use. If successful, this approach could lead to new clinical guidelines for catheter removal protocols, improving patient outcomes and reducing healthcare costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presenting to the urology clinic for catheter removal
- •Must be 18 years or older.
- •The patient must be able to understand and willing to provide informed consent as described in this study protocol.
- •Must be willing to complete a post-catheter removal survey
排除标准
- •Allergy or adverse reaction to chlorohexidine gluconate
- •Under the age of 18
- •Refuse to provide informed consent
- •On antibiotic therapy for any indication.
- •Women who are pregnant or breastfeeding
- •Signs of skin or systemic infection
- •Patients undergoing catheter exchange
研究组 & 干预措施
Control
Standard of care
干预措施: Normal Saline (Other)
Experimental
Experimental
干预措施: 0.05% Chlorhexidine Gluconate (Other)
结局指标
主要结局
Urinary tract infection
时间窗: 30 days
Evaluate the rate of urinary tract infection after urethral catheter removal.
次要结局
- Antibiotic use(30 days)
- Adverse Events(30 days)
研究者
Hiren Patel
Assistant Professor, Principal Investigator
Ohio State University