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Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients: Randomised Clinical Trial
Study in which a zinc oxide fixation device (a product that can help protect the skin) for catheters (polyurethane tubes inserted into a vein) will be tested to reduce catheter-related complications: catheter displacement, skin complications, phlebitis and pain..
Introduction: Midline catheters (MLC) and peripherally inserted central catheters (PICC) are commonly used vascular access devices (VAD) in healthcare institutions where infusion therapies are required, and have been proven to have an optimal level of safety and efficacy for intravenous drug delivery. However, the insertion of these VADs has a number of potential associated complications (immediate, early and/or late), and proper fixation may reduce them. Hypothesis: Using a zinc oxide adhesive securement device (ASD) reduces the number of fixation-associated complications in MLC and PICC compared to a universal ASD with silicone adhesive. Objective: To evaluate the efficacy of using a ASD with zinc oxide for post insertion fixation of MLC and PICC in hospitalised adult patients. Methodology: Randomised clinical study. Two randomised groups will be created before catheter cannulation. The control group will be cured with an ASD with acrylic adhesive (Grip-Lok® Ref.3300MWA) and the intervention group will be cured with ASD with zinc oxide (Grip-Lok® Ref.2200NUZA). Expected results: The investigators expect to reduce the number of complications related to the attachment of PICCs and MLCs in adult hospitalised patients following the protocolised placement of a ASD with zinc oxide during the first cure. Specifically, it is expected to reduce the number of catheter dislodgements, the number of medical adhesive-related skin injuries (MARSI) and the amount of phlebitis. Clinical implication: The study will help to improve decision making related to maintenance and care of VAD in order to reduce the main associated complications.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Arnau de Vilanova Hospital
Lleida, Catalonia, Spain
Hospital Universitari Arnau de Vilanova
Lleida, Catalonia, Spain
Start Date
February 1, 2025
Primary Completion Date
July 31, 2026
Completion Date
December 31, 2026
Last Updated
December 23, 2025
400
ESTIMATED participants
Control group: acrylic adhesive sutureless fixation device
PROCEDURE
Intervention Group: zinc oxide sutureless fixation device
PROCEDURE
PICC
DEVICE
Midline
DEVICE
Ultrasound scanner
OTHER
Padilla-Nula F Master of Science (MSc), Registred Nurse Certificated
CONTACT
+34 666115214FPADILLA@gencat.catLead Sponsor
Hospital Arnau de Vilanova
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06550479