Clinical trial NCT06375850: Effects of Topical Sesame Oil in the Prevention of Peripheral Venous Catheter Phlebitis: Clinical Trial.
Official title: Effects of Topical Sesame Oil in the Prevention of Chemotherapy-associated Peripheral Venous Catheter Phlebitis: Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Phlebitis
Keywords: Neoplasms
Antineoplastic Agents
Phlebitis
Sesame Oil
Catheterization
Peripheral
Lead sponsor: Hospital Universitario Marqués de Valdecilla
Sponsor class: OTHER
First posted: 2024-04-19
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Number of phlebitis in oncology patients with peripheral catheter to whom sesame oil is applied topically
timeFrame: one year
Secondary outcomes:
measure: Other adverse effects that appear in relation to the topical application of sesame oil in patients with peripheral catheters
timeFrame: one year
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
Study officials:
affiliation: Employee
name: Virginia Meneses Campos
role: PRINCIPAL_INVESTIGATOR
affiliation: Employee
name: Virginia Meneses
role: STUDY_DIRECTOR
References:
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citation: Goulart CB, Custodio CS, Vasques CI, Ferreira EB, Diniz Dos Reis PE. Effectiveness of topical interventions to prevent or treat intravenous therapy-related phlebitis: A systematic review. J Clin Nurs. 2020 Jul;29(13-14):2138-2149. doi: 10.1111/jocn.15266. Epub 2020 May 20.
citation: Nekuzad N, Ashke Torab T, Mojab F, Alavi-Majd H, Azadeh P, Ehtejab G. Effect of external use of sesame oil in the prevention of chemotherapy-induced phlebitis. Iran J Pharm Res. 2012 Fall;11(4):1065-71.
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