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

NCT06770374 | Recruiting FDA Device

• 1 other identifier: 03/24
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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

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

Keywords

Catheters; Vascular Access Devices; Catheter-Related Infections; Nurse Specialists; Nurses; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

  Percentage of participants with adverse events following cannulation of a midline or peripherally inserted central catheter after fixation with a zinc oxide sutureless fixation device.

  7 days

Secondary Outcomes (4)

• Number of participants with altered skin under the sutureless fixation device assessed by observation (yes/no).

  7 days

• Number of participants with post-treatment catheter displacement assessed by observation (yes/no).

  7 days

• Number of participants with post-treatment phlebitis assessed with the Maddox visual phlebitis rating scale.

  7 days

• Number of participants with post-treatment pain in extremity assessed with the EVA scale.

  7 days

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Procedure: Control group: acrylic adhesive sutureless fixation device; Device: PICC; Device: Midline; Other: Ultrasound scanner

Intervention

EXPERIMENTAL

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

Procedure: Intervention Group: zinc oxide sutureless fixation device; Device: PICC; Device: Midline; Other: Ultrasound scanner

Interventions

Ultrasound scanner OTHER

All punctures will be performed under ultrasound guidance.

Also known as: Ultrasound

Control; Intervention

Control group: acrylic adhesive sutureless fixation device PROCEDURE

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®).

Also known as: Control

Control

Intervention Group: zinc oxide sutureless fixation device PROCEDURE

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®).

Also known as: Intervention

Intervention

PICC DEVICE

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

Control; Intervention

Midline DEVICE

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

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- patients with a known allergy to zinc oxide

Sponsors & Collaborators

• Hospital Arnau de Vilanova: lead
• Department of Health, Generalitat de Catalunya (PERIS): collaborator
• Official College of Nurses of Lleida: collaborator

Study Sites (2)

Arnau de Vilanova Hospital

Lleida, Catalonia, 25001, Spain

RECRUITING

Hospital Universitari Arnau de Vilanova

Lleida, Catalonia, 25198, Spain

COMPLETED

Related Publications (17)

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  PMID: 37152837 RESULT

MeSH Terms

Conditions

Skin Diseases; Phlebitis; Pain; Catheter-Related Infections

Interventions

Methods; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Peripheral Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Vasculitis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infections

Intervention Hierarchy (Ancestors)

Investigative Techniques; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Padilla-Nula F PhD candidate, Nurse

CONTACT

+ 34 973 24 81 00; FPADILLA@gencat.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The researchers are the ones who performed the insertion of the catheters and the subsequent data collection, but the patients do not know which ones have the zinc oxide device and which ones do not. In addition, the results will be evaluated by a researcher external to the data collection.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Classic parallel model with an intervention group, where the catheters will be fixed with a zinc oxide fixation dressing (Grip-Lok® Ref.2200NUZA), and a control group where the catheters will be fixed with a dressing without zinc oxide (acrylic adhesive) (Grip-Lok® Ref.3300MWA).

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 13, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Open
• Access Criteria: Will be accessible to everyone through the Mendelay data platform.

Locations

ES (2)