Medical Adhesive and Barrier Products for Preventing MARSI in Central Venous Catheter Dressings

Официальное название

Effect of Medical Adhesive and Skin Barrier Products Used for Central Venous Catheter Dressings on the Development of Medical Adhesive-Related Skin Injury: A Randomized Controlled Trial

Обзор

The goal of this clinical trial is to compare three different dressing securement strategies used for central venous catheters (CVCs) to determine which is more effective in preventing medical adhesive-related skin injury (MARSI) among adults admitted to a Chest Diseases Intensive Care Unit. The main questions it aims to answer are: Does the type of dressing securement affect the occurrence of MARSI? Which dressing securement strategy is most effective in preventing CVC-related MARSI? Researchers will compare: acrylic adhesive tape, silicone adhesive tape, and barrier film combined with acrylic adhesive tape to determine which dressing securement strategy provides the best protection against CVC-related MARSI. Participants will: be randomly assigned to one of the three dressing securement strategies, receive the assigned dressing securement throughout the study period, undergo regular skin assessments for signs of MARSI, and be followed for up to 21 days or until catheter removal.

Подробное описание

Medical adhesive-related skin injury (MARSI) is a preventable complication caused by the application or removal of medical adhesives used to secure medical devices. MARSI includes skin stripping, skin tears, blistering, contact dermatitis, folliculitis, and maceration, and may lead to pain, impaired skin integrity, increased infection risk, unplanned dressing replacement, prolonged hospitalization, and increased healthcare costs.

Patients with central venous catheters (CVCs), particularly those admitted to intensive care units, are at increased risk of MARSI because of repeated dressing changes, prolonged exposure to adhesive products, impaired skin integrity, and multiple intrinsic and extrinsic risk factors. Previous studies have reported that the incidence of CVC-related MARSI ranges from approximately 11% to 32%, with the cervical region being the most commonly affected anatomical site.

Although various adhesive and skin protection products are available for CVC securement, evidence directly comparing their effectiveness in preventing CVC-related MARSI remains limited. Most previous studies have been observational, included relatively small sample sizes, had short follow-up periods, or evaluated skin injury as a secondary outcome rather than a primary endpoint. Consequently, there is insufficient high-quality comparative evidence to guide the selection of the most effective securement strategy for preventing MARSI in patients with CVCs.

This prospective, single-center, three-arm, parallel-group, randomized controlled trial is designed to compare the effectiveness of acrylic adhesive tape, silicone adhesive tape, and barrier film combined with acrylic adhesive tape in preventing CVC-related MARSI. Adult patients requiring an internal jugular CVC will be randomly assigned in a 1:1:1 ratio to one of the three intervention groups using stratified block randomization based on age and sex. Because the interventions are visually distinguishable, participant and care provider blinding is not feasible. Group allocation will be concealed from the statistician during data analysis. Participants will be followed for up to 21 days or until catheter removal.

The primary objectives are to compare the occurrence and incidence of CVC-related MARSI among the intervention groups. Secondary objectives are to compare the time to MARSI development, MARSI severity, and MARSI type. The findings of this study are expected to provide high-quality comparative evidence to support evidence-based nursing practice and identify the most effective adhesive securement strategy for preventing CVC-related MARSI among adult patients admitted to a Chest Diseases Intensive Care Unit.

Вмешательства

• Устройство Acrylic Adhesive Tape
  A physician will insert a non-tunneled internal jugular central venous catheter using sterile technique and secure the catheter to the skin with sutures according to routine clinical practice. Following skin antisepsis, the insertion site will be covered with sterile 2 × 2 cm gauze and secured with a 10 × 10 cm acrylic adhesive tape. Dressings will be changed every 24 hours or earlier if clinically indicated. Participants will be followed for up to 21 days or until catheter removal, with assessm
• Устройство Silicone Adhesive Tape
  A physician will insert a non-tunneled internal jugular central venous catheter using sterile technique and secure the catheter to the skin with sutures according to routine clinical practice. Following skin antisepsis, the insertion site will be covered with sterile 2 × 2 cm gauze and secured with a 10 × 10 cm silicone adhesive tape. Dressings will be changed every 24 hours or earlier if clinically indicated. Participants will be followed for up to 21 days or until catheter removal, with assess
• Устройство Skin Barrier Film + Acrylic Adhesive Tape
  A physician will insert a non-tunneled internal jugular central venous catheter using sterile technique and secure the catheter to the skin with sutures according to routine clinical practice. Following skin antisepsis, the insertion site will be covered with sterile 2 × 2 cm gauze. A skin barrier film will be applied to the surrounding skin and allowed to dry before securing the dressing with a 10 × 10 cm acrylic adhesive tape. Dressings will be changed every 24 hours or earlier if clinically i

Первичные конечные точки

• Incidence of Medical Adhesive-Related Skin Injury (MARSI) [Срок оценки: From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).]

Вторичные конечные точки (3)

• Time to First Medical Adhesive-Related Skin Injury [Срок оценки: From randomization until catheter removal or up to 21 days.]
• Severity of Medical Adhesive-Related Skin Injury [Срок оценки: From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).]
• Type of Medical Adhesive-Related Skin Injury [Срок оценки: From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).]

Критерии участия

Критерии включения

• Patients aged 18 years or older.
• Patients scheduled to undergo insertion of a non-tunneled central venous catheter via the internal jugular vein in the chest intensive care unit or operating room.
• Patients who provide written informed consent to participate in the study, either personally or through their legally authorized representative.
• Patients with intact skin and no pre-existing skin condition at the catheter insertion site.

Критерии исключения

• Patients with an active or congenital dermatological disease.
• Patients with a known history of allergic reactions to any of the securement products used in the study (medical adhesive tapes or protective barrier film).
• Patients with clinically significant hyperhidrosis (excessive sweating).
• Patients whose central venous catheter is inserted through a site other than the internal jugular vein (e.g., subclavian or femoral vein).
• Patients requiring contact isolation because of an infectious disease (e.g., scabies) or airborne isolation because of a contagious disease (e.g., tuberculosis).

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

Открытое

Основная цель

Профилактика

Центры проведения

Turkey (Türkiye) · 1 центр

• Afyonkarahisar Health Sciences University Health Practice and Research Center — Afyonkarahisar

Идентификаторы

NCT: NCT07697430 · EÜ-SBE-HE-93220000072-CIP-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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