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Recruiting Not applicable

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

NCT07697430 · tracked via the Priya Life Science Turkey tracker
Sponsor
Azize Özdaş Gündoğan
Phase
Not applicable
Started
2026-06-01
Last updated
2026-07-21

Condition(s) studied

Medical Adhesive Related Skin InjuryCentral Venous Catheter

Investigational drug(s) / intervention(s)

Acrylic Adhesive TapeSilicone Adhesive TapeSkin Barrier Film + Acrylic Adhesive Tape

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 assessment for medical adhesive-related skin injury (MARSI) at each dressing change.

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 assessment for medical adhesive-related skin injury (MARSI) at each dressing change.

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 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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).

Primary outcome measure(s)

  • 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).

Trial sites (1)

FacilityCityRegionStatus
Afyonkarahisar Health Sciences University Health Practice and Research Center Afyonkarahisar Center Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07697430 on ClinicalTrials.gov ↗ ← All trials in Turkey