Medical Adhesive and Barrier Products for Preventing MARSI in Central Venous Catheter Dressings
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
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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Center
-
Afyonkarahisar, Center, Turquía (Türkiye), 03030
- Reclutamiento
- Afyonkarahisar Health Sciences University Health Practice and Research Center
-
Contacto:
- Azize Ozdas Gundogan, RN, MSc
- Número de teléfono: +90533 615 36 55
- Correo electrónico: azize.ozdas@afsu.edu.tr
-
Investigador principal:
- Ibrahım Guven Cosgun, MD
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Acrylic Adhesive Tape
Participants will receive central venous catheter securement using an acrylic adhesive tape according to the standardized dressing protocol.
Dressing application, assessment, and replacement will be performed following the study protocol throughout catheterization.
|
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 assessment for medical adhesive-related skin injury (MARSI) at each dressing change.
|
|
Experimental: Silicone Adhesive Tape
Participants will receive central venous catheter securement using a silicone adhesive tape according to the standardized dressing protocol.
Dressing application, assessment, and replacement will be performed following the study protocol throughout catheterization.
|
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 assessment for medical adhesive-related skin injury (MARSI) at each dressing change.
|
|
Experimental: Barrier Film + Acrylic Adhesive Tape
Participants will receive a skin barrier film before application of an acrylic adhesive tape for central venous catheter securement according to the standardized dressing protocol.
Dressing application, assessment, and replacement will be performed following the study protocol throughout catheterization.
|
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 indicated.
Participants will be followed for up to 21 days or until catheter removal, with assessment for medical adhesive-related skin injury (MARSI) at each dressing change.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Incidence of Medical Adhesive-Related Skin Injury (MARSI)
Periodo de tiempo: From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).
|
Incidence of medical adhesive-related skin injury (MARSI) at the central venous catheter dressing site, classified according to the international consensus recommendations (mechanical injury, dermatitis, or other skin injuries).
|
From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Time to First Medical Adhesive-Related Skin Injury
Periodo de tiempo: From randomization until catheter removal or up to 21 days.
|
Time from catheter dressing application to the first occurrence of medical adhesive-related skin injury.
|
From randomization until catheter removal or up to 21 days.
|
|
Severity of Medical Adhesive-Related Skin Injury
Periodo de tiempo: From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).
|
Severity of MARSI classified as mild, moderate, or severe according to the Wang et al. grading system.
|
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
Periodo de tiempo: 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 (MARSI) classified according to the international consensus as mechanical injury, dermatitis, maceration, folliculitis, or other skin injuries.
|
From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Unidad de Cuidados Intensivos
- Ensayo controlado aleatorizado
- Enfermería
- Catéter venoso central
- Película de barrera
- MARSI
- Medical Adhesive Related Skin Injury
- Central Venous Catheter Dressing
- Acrylic Adhesive Tape
- Silicone Adhesive Tape
- Skin Injury
- medical adhesive tapes
- Central venous catheter dressing fixation
Otros números de identificación del estudio
- EÜ-SBE-HE-93220000072-CIP-01
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .