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

Hospital Universitario Marqués de Valdecilla

Status: Enrolling

Conditions: Phlebitis

Treatments: Other: Sesame oil; Other: Saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT06375850

Effects of topical sesame oil

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

This arm will be administered 2 drops of sesame oil daily along the channeled vein, about 3 centimeters from the insertion point.

Treatment:

Other: Sesame oil

Control

Placebo Comparator group

Description:

This arm will be administered 2 drops of physiological saline daily along the channeled vein, about 3 centimeters from the insertion point.

Treatment:

Other: Saline solution