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临床试验/NCT06375850
NCT06375850Unknown不适用

Effects of Topical Sesame Oil in the Prevention of Chemotherapy-associated Peripheral Venous Catheter Phlebitis: Clinical Trial.

Hospital Universitario Marqués de Valdecilla2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2022年6月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
2
主要终点
Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically

研究概览

简要总结

Cancer is a disease that, despite having a higher cure rate, is currently on the rise, with an increase in the number of diagnoses.

For the treatment of these patients a venous access is required, which in the first treatments is of peripheral insertion. These peripheral venous catheter in combination with the highly aggressive treatments for the veins are the cause of the appearance of chemical phlebitis.

Phlebitis is an inflammation caused by a combination of factors, whether chemical, perfusion of irritating medication; mechanical, due to the puncture site, type and fixation of the catheter and infectious, caused by the colonization of pathogenic agents whose origin is the skin and that migrate inward.

Phlebitis involves an injury to the wall of the vein, and consequently, the patient will also be at risk of thrombus formation, which in turn leads to thrombophlebitis, deep vein thrombosis or pulmonary embolism.

The existence of phlebitis involves intense and constant pain, with increased sensitivity and a sensation of heat and swelling.

With the use of topical sesame oil, and thanks to its anti-inflammatory properties, the investigators intend to study whether it is effective in preventing the appearance 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
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

入选标准

  • Be over 18 years of age.
  • To be conscious and have a cognitive state that allows him/her to give consent to participate in the study.
  • Be diagnosed with a neoplasm that requires chemotherapy treatment.
  • To be a carrier of a CVP in the upper extremity as vascular access for chemotherapy administration.

排除标准

  • Being allergic to sesame oil.
  • Be allergic to nuts.
  • Not being able to speak, read and write in Spanish.
  • Last days or palliative situation.

结局指标

主要结局

Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically

时间窗: one year

Sesame oil will be applied in the intervention groups, with the aim of assessing whether its application decreases the occurrence of phlebitis in oncology patients with irritating and high osmolarity intravenous medication.

次要结局

  • Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral catheters(one year)

研究者

发起方
Hospital Universitario Marqués de Valdecilla
申办方类型
Other
责任方
Principal Investigator
主要研究者

Virginia Meneses Campos

Principal Investigator

Hospital Universitario Marqués de Valdecilla

研究点 (2)

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