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Trial Title:
Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial.
NCT ID:
NCT06375850
Condition:
Phlebitis
Conditions: Official terms:
Phlebitis
Conditions: Keywords:
Neoplasms
Antineoplastic Agents
Phlebitis
Sesame Oil
Catheterization
Peripheral
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Sesame oil
Description:
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.
Arm group label:
Intervention
Intervention type:
Other
Intervention name:
Saline solution
Description:
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.
Arm group label:
Control
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Hospital Universitario Marqués de Valdecilla
Address:
City:
Santander
Zip:
39008
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Virginia Meneses Campos
Phone:
+34942202520
Email:
virginia.meneses@scsalud.es
Investigator:
Last name:
Virginia Meneses Campos
Email:
Principal Investigator
Start date:
June 5, 2022
Completion date:
May 11, 2025
Lead sponsor:
Agency:
Hospital Universitario Marqués de Valdecilla
Agency class:
Other
Source:
Hospital Universitario Marqués de Valdecilla
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06375850
https://www.cancer.gov/
https://seom.org/
