A Multi-Center, Prospective, Randomized Trial Comparing the Peripheral I.V. Catheter Complication Rates of Two Different Catheter Dressings
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 247
- 试验地点
- 10
- 主要终点
- Dressing Wear Time
研究概览
简要总结
A multi-center randomized control trial comparing the dressing wear times of two different transparent film dressings when used to secure peripheral intravenous catheters of hospitalized adult patients.
详细描述
A multi-center, prospective, randomized control trial comparing the dressing wear time, complication rates and cost of two different transparent film dressing when used as intended for peripheral intravenous catheter site protection and securement in five U.S. hospitals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •At least 18 years of age, or of consenting age;
- •Admitted or going to be admitted to the hospital;
- •Requires peripheral IV therapy (catheter) for an anticipated 72 hours or longer;
- •Has an insertion site in the forearm or hand free of phlebitis, infiltration, dermatitis, burns, lesions or tattoos;
- •Demonstrates cooperation with a catheter insertion and the securement protocol; and
- •Patient or legally authorized representative is willing and able to provide written informed consent and authorization for use and disclosure of Protected Health Information
排除标准
- •Is a current participant or a past participant in this study;
- •If the subject already has a functioning PIV in place, not requiring a replacement catheter
- •If the study PIV catheter site will be placed below an old infusion site;
- •If the study PIV site needs to be immobilized with a splint or other device;
- •Has a documented or a known allergy or sensitivity to a medical adhesive product such as transparent film adhesive dressings, tapes, or liquid skin protectants;
- •Requires the application of a gauze pad, a topical ointment or solution under the dressing in addition to the prep(s) required in the protocol;
- •Will require a power injection through the study PIV catheter for a radiologic procedure during participation in this study;
- •Will require a numbing agent prior to PIV insertion; or
- •Will require the use of ultrasound for the PIV catheter insertion.
结局指标
主要结局
Dressing Wear Time
时间窗: Dressing wear time was assessed daily and 8 month dressing wear data are presented
Dressing wear time is the time from dressing application to removal, i.e. catheter no longer needed or catheter-related complication occurs (remove dressing and catheter) OR excessive dressing lift requiring dressing replacement.
次要结局
未报告次要终点