Central Venous Catheter, Medical Adhesive Related Skin Injury
Conditions
Keywords
MARSI, Medical Adhesive Related Skin Injury, Central Venous Catheter, Central Venous Catheter Dressing, Acrylic Adhesive Tape, Silicone Adhesive Tape, Barrier Film, Intensive Care Unit, Nursing, Skin Injury, Randomized Controlled Trial, medical adhesive tapes, Central venous catheter dressing fixation
Brief summary
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.
Detailed description
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.
Interventions
DEVICEAcrylic 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 assessment for medical adhesive-related skin injury (MARSI) at each dressing change.
DEVICESilicone 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 assessment for medical adhesive-related skin injury (MARSI) at each dressing change.
DEVICESkin 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 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.
Sponsors
Azize Özdaş Gündoğan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Due to the physical differences between the securement products, participants and care providers cannot be masked to group allocation. Therefore, the intervention will be conducted as open-label at the participant and care-provider level. However, outcome assessment/statistical analysis will be performed under masked conditions. Group allocation codes will be concealed from the statistician/outcome assessor until the primary analyses are completed.
Intervention model description
Participants will be randomly assigned in a 1:1:1 ratio to one of three parallel intervention groups receiving central venous catheter securement with acrylic adhesive tape, silicone adhesive tape, or barrier film combined with acrylic adhesive tape. Stratified block randomization based on age and sex will be used to ensure balanced allocation among the intervention groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Medical Adhesive-Related Skin Injury (MARSI) | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Medical Adhesive-Related Skin Injury | 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. |
| Severity of Medical Adhesive-Related Skin Injury | 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. |
| Type of Medical Adhesive-Related Skin Injury | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed