A Randomized, Double Blind, Placebo-controlled Clinical Trial Assessing the Utility of Antibiotic Prophylaxis Prior to Totally Implanted Venous Access Device (TIVAD) Insertion
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Number of participants with CRBSI
研究概览
简要总结
A randomized, double blind, placebo-controlled clinical trial assessing the utility of antibiotic prophylaxis prior to Totally Implanted Venous Access Device (TIVAD) insertion.
详细描述
To assess the effectiveness of peri-procedural antibiotic prophylaxis in the reduction of TIVAD placement-related infection, study will compare placebo (normal saline (0.9% NaCl)) 50 cc IV 1:1 to the standard clinical antibiotic prophylaxis dose. The primary endpoint is cumulative incidence of local TIVAD surgical site infection (as determined by the CDC criteria for a deep and/or superficial SSI) or a central line associated blood stream infection at 30 days.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo and antibiotic packaged similarly, code identified by Investigational Pharmacy. Patients and providers will not know which had been administered.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients requiring TIVAD insertion for long-term central venous access
- •Patients able to give informed consent to participate in the study.
排除标准
- •taking long-term antibiotics
- •unable to give consent to participate in the study
- •Patients that have a known infection at time of the procedure (as documented in e-DH).
- •Patients with a planned surgical procedure within 30 days of initial TIVAD insertion.
- •Patients that are currently on antibiotics or have received antibiotics within the last week.
- •Patients with allergies to cefazolin.
- •Patients with an absolute neutrophil count of less than 500/mm3
- •Women who are pregnant.
研究组 & 干预措施
placebo
patients receive saline infusion prior to port placement
干预措施: saline (Other)
antibiotic
patients receive antibiotic (Cefazolin 2 g) infusion prior to port placement
干预措施: Cefazolin (Drug)
结局指标
主要结局
Number of participants with CRBSI
时间窗: 30 days after procedure
catheter-related bloodstream infection (CRBSI); Effectiveness will be evaluated by comparing infection rates between patients that receive systemic prophylactic antibiotic and those that receive a placebo
Number of participants with surgical site infection
时间窗: 30 days after procedure
surgical site infection; Effectiveness will be evaluated by comparing infection rates between patients that receive systemic prophylactic antibiotic and those that receive a placebo
次要结局
- Average cost of systemic prophylactic antibiotic administration compared to the cost of treating TIVAD insertion related infections(30 days after procedure)
研究者
Eric K. Hoffer
Director, Vascular and Interventional Radiology
Dartmouth-Hitchcock Medical Center