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

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..

Conditions

• Vascular Access Complication
• Skin and Subcutaneous Tissue Disorders
• Phlebitis
• Pain

Interventions

PROCEDURE

Control 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®).

PROCEDURE

Intervention 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®).

DEVICE

PICC

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

DEVICE

Midline

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

OTHER

Ultrasound scanner

All punctures will be performed under ultrasound guidance.

Sponsors & Collaborators

• Official College of Nurses of Lleida

  collaborator UNKNOWN

• Department of Health, Generalitat de Catalunya (PERIS)

  collaborator UNKNOWN

• Hospital Arnau de Vilanova

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2026-07-31

Completion

2026-12-31

FDA Device

Yes

Countries

• Spain

Study Locations