Randomized, Prospective, Single-center Trial Comparing the Efficacy of Peripherally Inserted Central Catheter (PICC) Placement With the Addition of Cyanoacrylate Glue Versus PICC Placement Alone (Without Glue) in Patients With Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Rate of patients with successful PICC placement
研究概览
简要总结
This is a randomized, prospective, single-center trial comparing the efficacy of peripherally inserted central catheter (PICC) with the addition of cyanoacrylate glue versus PICC placement alone (without glue) in cancer patients.
详细描述
Peripherally Inserted Central Catheters (PICCs) are a form of vascular access inserted percutaneously into a vein, usually in the arm, with the distal end at the atrio cava junction (between the superior vena cava and the right atrium). They may be used for a prolonged period or for several days, repeatedly over time (as is the case for certain chemotherapies, parenteral nutrition or long-term intravenous treatments).
Their placement requires aseptic surgical conditions, and a team trained in the procedure, sometimes grouped together in a Vascular Access Unit (UAV).
A PICC is inserted by puncturing the skin and subcutaneous tissues, and securing the catheter with a "Statlock" type stabilizer. The catheter exit point must be covered, at a minimum by a sterile occlusive dressing with a transparent semi-permeable membrane, otherwise referred to as a "transparent dressing".
According to available data, tissue puncture results in bleeding at the puncture site in 25% to 40% of procedures. This bleeding necessitates the application of a sterile compress prior to covering with a transparent dressing. The skin puncture site (also known as the catheter exit point) requires the dressing to be repeated on D1 after insertion.
To sum up:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Male or female, 18 years of age or older on the date of signature the informed consent form
- •Patient with a histological diagnosis of cancer
- •Indication for central line chemotherapy or immunotherapy
- •Placement of a single-lumen PICC in the non-tunneled upper limb planned on an ambulatory basis at the Centre
- •Planned duration of PICC use > 30 days
- •Dated and signed informed consent, indicating that the patient has been informed of all relevant aspects of the study prior to inclusion;
- •Patient covered by a health insurance plan
排除标准
- •Patient already included in the study ;
- •Patient with known allergy to cyanoacrylates, Violet D&C or formaldehyde;
- •Patient not reachable by telephone ;
- •Patient under guardianship;
- •Patient does not speak French.
结局指标
主要结局
Rate of patients with successful PICC placement
时间窗: Hour 0
Success is defined by the possibility of using a dressing without compression at application (at hour 0), i.e. without bleeding after the defined compression time.
次要结局
- Proportion of dressing changes before day 8(Up to day 8)
- Proportion of dressing changes within one hour(Up to hour 1)
- Proportion of dressing changes before day 30(Up to day 30)
- Incidence of PICC removal before day 30(Up to day 30)
- Incidence of PICC-related complications before day 30(Up to day 30)