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

April 16, 2024 updated by: Virginia Meneses Campos, Hospital Universitario Marqués de Valdecilla

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Virginia Meneses Campos
  • Phone Number: +34942202520

Study Locations

  • Spain
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla
        • Contact:
        • Principal Investigator:
          • Virginia Meneses Campos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
This arm will be administered 2 drops of sesame oil daily along the channeled vein, about 3 centimeters from the insertion point.
Other: Sesame oil

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.
Placebo Comparator: Control
This arm will be administered 2 drops of physiological saline daily along the channeled vein, about 3 centimeters from the insertion point.
Other: Saline 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically
Time Frame: 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.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral catheters
Time Frame: one year
Registration of other adverse effects related to chemotherapy administration through a peripheral catheter: extravasation, number of cannulations during admission, catheter duration and reason for withdrawal.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario Marqués de Valdecilla

Investigators

  • Principal Investigator: Virginia Meneses Campos, Employee
  • Study Director: Virginia Meneses, Employee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2022

Primary Completion (Estimated)

February 11, 2025

Study Completion (Estimated)

May 11, 2025

Study Registration Dates

First Submitted

February 29, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Effects of topical sesame oil

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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