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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06375850
Enrollment
300
Registered
2024-04-19
Start date
2022-06-05
Completion date
2025-05-11
Last updated
2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phlebitis

Keywords

Neoplasms, Antineoplastic Agents, Phlebitis, Sesame Oil, Catheterization, Peripheral

Brief summary

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.

Interventions

A peripheral venous catheter will be channeled to the patient admitted to the unit and who requires it. The indications included in the guide for channeling venous access of the Marqués de Valdecilla hospital will be followed. Once the venous access has been channeled, it will be fixed with, leaving the puncture point visible for future monitoring. The sesame oil chosen for the project is Sesame bio - 100% pure vegetable oil from the Naissance brand. To perform the procedure, two drops of sesame oil will be applied daily by the nurse in charge of the patient during the morning shift in the area about 2 cm above the insertion point and coinciding with the course of the vein channeled for intravenous therapy. A small massage of the area of application will be performed, with an approximate extension of 3x3cm, until its absorption. It will be left to dry in the air.

OTHERSaline solution

After cannulation of the vein following the same procedure as explained in the intervention arm, patients belonging to the control arm will be administered two drops of saline solution.

Sponsors

Hospital Universitario Marqués de Valdecilla
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topicallyone yearSesame 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.

Secondary

MeasureTime frameDescription
Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral cathetersone yearRegistration of other adverse effects related to chemotherapy administration through a peripheral catheter: extravasation, number of cannulations during admission, catheter duration and reason for withdrawal.

Countries

Spain

Contacts

Primary ContactVirginia Meneses Campos
virginia.meneses@scsalud.es+34685953641
Backup ContactVirginia Meneses Campos
+34942202520

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026