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

Официальное название

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

Обзор

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..

Подробное описание

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.

Вмешательства

• Процедура 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®).
• Процедура 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®).
• Устройство 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
• Устройство 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
• Другое Ultrasound scanner
  All punctures will be performed under ultrasound guidance.

Первичные конечные точки

• Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. [Срок оценки: 7 days]

Вторичные конечные точки (4)

• Number of participants with altered skin under the sutureless fixation device assessed by observation (yes/no). [Срок оценки: 7 days]
• Number of participants with post-treatment catheter displacement assessed by observation (yes/no). [Срок оценки: 7 days]
• Number of participants with post-treatment phlebitis assessed with the Maddox visual phlebitis rating scale. [Срок оценки: 7 days]
• Number of participants with post-treatment pain in extremity assessed with the EVA scale. [Срок оценки: 7 days]

Критерии участия

Критерии включения

• 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

Критерии исключения

\- patients with a known allergy to zinc oxide

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Испания · 2 центра

• Arnau de Vilanova Hospital — Lleida
• Hospital Universitari Arnau de Vilanova — Lleida

Публикации

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• Xu H, Hyun A, Mihala G, Rickard CM, Cooke ML, Lin F, Mitchell M, Ullman AJ. The effectiveness of dressings and securement devices to prevent central venous catheter-associated complications: A systematic review and meta-analysis. Int J Nurs Stud. 2024 Jan;149:104620. doi: 10.1016/j.ijnurstu.2023.104620. Epub 2023 Oct 9. PMID 37879273
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Идентификаторы

NCT: NCT06770374 · 03/24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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