Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
研究概览
简要总结
Study in which a zinc oxide fixation device (a product that can help protect the skin) for catheters (polyurethane tubes inserted into a vein) will be tested to reduce catheter-related complications: catheter displacement, skin complications, phlebitis and pain..
详细描述
Introduction: Midline catheters (MLC) and peripherally inserted central catheters (PICC) are commonly used vascular access devices (VAD) in healthcare institutions where infusion therapies are required, and have been proven to have an optimal level of safety and efficacy for intravenous drug delivery. However, the insertion of these VADs has a number of potential associated complications (immediate, early and/or late), and proper fixation may reduce them.
Hypothesis: Using a zinc oxide adhesive securement device (ASD) reduces the number of fixation-associated complications in MLC and PICC compared to a universal ASD with silicone adhesive.
Objective: To evaluate the efficacy of using a ASD with zinc oxide for post insertion fixation of MLC and PICC in hospitalised adult patients.
Methodology: Randomised clinical study. Two randomised groups will be created before catheter cannulation. The control group will be cured with an ASD with acrylic adhesive (Grip-Lok® Ref.3300MWA) and the intervention group will be cured with ASD with zinc oxide (Grip-Lok® Ref.2200NUZA).
Expected results: The investigators expect to reduce the number of complications related to the attachment of PICCs and MLCs in adult hospitalised patients following the protocolised placement of a ASD with zinc oxide during the first cure. Specifically, it is expected to reduce the number of catheter dislodgements, the number of medical adhesive-related skin injuries (MARSI) and the amount of phlebitis.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The researchers are the ones who performed the insertion of the catheters and the subsequent data collection, but the patients do not know which ones have the zinc oxide device and which ones do not. In addition, the results will be evaluated by a researcher external to the data collection.
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
- •requiring cannulation of a midline catheter or a PICC
- •who accepted and signed the informed consent voluntarily
- •with an inpatient unit admission of minimum 7 days
排除标准
- •- patients with a known allergy to zinc oxide
研究组 & 干预措施
Control
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care.
干预措施: Control group: acrylic adhesive sutureless fixation device (Procedure)
Intervention
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the intervention group underwent the alternative care.
干预措施: Ultrasound scanner (Other)
Control
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care.
干预措施: PICC (Device)
Control
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care.
干预措施: Midline (Device)
Control
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care.
干预措施: Ultrasound scanner (Other)
Intervention
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the intervention group underwent the alternative care.
干预措施: Intervention Group: zinc oxide sutureless fixation device (Procedure)
Intervention
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the intervention group underwent the alternative care.
干预措施: PICC (Device)
Intervention
After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the intervention group underwent the alternative care.
干预措施: Midline (Device)
结局指标
主要结局
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
时间窗: 7 days
Percentage of participants with adverse events following cannulation of a midline or peripherally inserted central catheter after fixation with a zinc oxide sutureless fixation device.
次要结局
- Number of participants with altered skin under the sutureless fixation device assessed by observation (yes/no).(7 days)
- Number of participants with post-treatment catheter displacement assessed by observation (yes/no).(7 days)
- Number of participants with post-treatment phlebitis assessed with the Maddox visual phlebitis rating scale.(7 days)
- Number of participants with post-treatment pain in extremity assessed with the EVA scale.(7 days)
研究者
Ferran Padilla Nula
Principal Investigator
Hospital Arnau de Vilanova