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

Hospital Arnau de Vilanova

Status: Enrolling

Conditions: Skin and Subcutaneous Tissue Disorders; Vascular Access Complication; Phlebitis; Pain

Treatments: Other: Ultrasound scanner; Procedure: Control group: acrylic adhesive sutureless fixation device; Device: Midline; Device: PICC; Procedure: Intervention Group: zinc oxide sutureless fixation device

Study type: Interventional

Funder types: Other

Identifiers

NCT06770374

03/24

Details and patient eligibility

About

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..

Full 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.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 criteria

- patients with a known allergy to zinc oxide

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

400 participants in 2 patient groups

Control

Active Comparator group

Description:

After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the control group underwent standard care.

Treatment:

Device: PICC

Device: Midline

Procedure: Control group: acrylic adhesive sutureless fixation device

Other: Ultrasound scanner

Intervention

Experimental group

Description:

After cannulation of a midline or peripherally inserted central venous catheter with modified micro-Seldinger technique, the intervention group underwent the alternative care.

Treatment:

Procedure: Intervention Group: zinc oxide sutureless fixation device

Device: PICC

Device: Midline

Other: Ultrasound scanner