An interventional study of Sesame oil and Saline solution in Phlebitis, sponsored by Hospital Universitario Marqués de Valdecilla. Recruiting at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by Hospital Universitario Marqués de Valdecilla · Not applicable, Interventional, and Prevention
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.
45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.
This study's planned enrollment of 300 is above the median of 134 across 38 interventional studies indexed under Phlebitis.
Browse Phlebitis studies →Hospital Universitario Marqués de Valdecilla is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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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
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
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.
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.
Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically
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.
Time frame: one year
Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral catheters
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.
Time frame: one year
Started Jun 2022 (actual). Primary completion is estimated for Feb 2025, 32 months after the start.
Of 21 interventional studies with no phase under Phlebitis, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 16. This study's planned 32 months is above that.
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Hospital Universitario Marqués de Valdecilla