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

Last updated: December 21, 2025
Sponsor: Hospital Arnau de Vilanova
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pain

Catheter Complications

Treatment

Midline

Intervention Group: zinc oxide sutureless fixation device

PICC

Clinical Study ID

NCT06770374
03/24
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • patients with a known allergy to zinc oxide

Study Design

Total Participants: 400
Treatment Group(s): 6
Primary Treatment: Midline
Phase:
Study Start date:
February 01, 2025
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Arnau de Vilanova Hospital

    Lleida, Catalonia 25001
    Spain

    Site Not Available

  • Arnau de Vilanova Hospital

    Lleida 3118514, Catalonia 3336901 25001
    Spain

    Active - Recruiting

  • Hospital Universitari Arnau de Vilanova

    Lleida 3118514, Catalonia 3336901 25198
    Spain

    Completed

  • Hospital Universitari Arnau de Vilanova

    Lleida, Cataluña 25198
    Spain

    Completed

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