RecruitingNot ApplicableNCT06770374

Effectiveness of a Zinc Oxide Adhesive Securement Device in the Fixation of Midline and Peripherally Inserted Central Catheters in Hospitalized Adult Patients

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

Sponsor

Hospital Arnau de Vilanova

Enrollment

400 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Phlebitis Pain Vascular Access Complication Skin and Subcutaneous Tissue Disorders

Summary

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..

Eligibility

Min Age: 18 Years

Inclusion Criteria3

requiring cannulation of a midline catheter or a PICC
who accepted and signed the informed consent voluntarily
with an inpatient unit admission of minimum 7 days

Exclusion Criteria1

\- patients with a known allergy to zinc oxide

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Interventions

PROCEDUREControl group: acrylic adhesive sutureless fixation device

The standard care consists of: * Application of hemostasis at the point of insertion for 2 minutes post puncture or until bleeding stops. * Fix with clear polyurethane dressing (3M®-1655 Tegaderm™ IV), cyanoacrylate glue (SecurePortIV®) and acrylic adhesive sutureless fixation device (3300MWA Grip-Lok®).

PROCEDUREIntervention Group: zinc oxide sutureless fixation device

Alternative care consisted of: * Application of haemostasis at the insertion site for 2 minutes post-puncture or until cessation of bleeding. * Fixation with clear polyurethane dressing (3M®-1655 Tegaderm™ IV), cyanoacrylate glue (SecurePortIV®) and zinc oxide sutureless fixation device (2200NUZA Grip-Lok®).

DEVICEPICC

The PICC lines used in the study will all be third-generation polyurethane and of the commercial brands: * PowerPICC™ 4, 5 and 6 Fr from BD * Maxflo expert™ 5 and 6 Fr from Vygon

DEVICEMidline

The midline lines used in the study will be second or third generation polyurethane and of the commercial brands: * PowerMidline™ 4 Fr from BD * Arrow® Midline 4Fr from Arrow

OTHERUltrasound scanner

All punctures will be performed under ultrasound guidance.