Medical Adhesive and Barrier Products for Preventing MARSI in Central Venous Catheter Dressings
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAzize Özdaş Gündoğan
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Acrylic Adhesive Tape
DeviceA 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
DeviceA 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
DeviceA 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.
Treatment groups
162 Participants
are divided into 3 treatment groupsGroup A: Acrylic Adhesive TapeExperimental treatment 1 intervention
Group B: Silicone Adhesive TapeExperimental treatment 1 intervention
Group C: Barrier Film + Acrylic Adhesive TapeExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Medical Adhesive-Related Skin Injury (MARSI)
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).
Time frame
From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).Secondary outcomes
1
Time to First Medical Adhesive-Related Skin Injury
Time from catheter dressing application to the first occurrence of medical adhesive-related skin injury.
Time frame
From randomization until catheter removal or up to 21 days.2
Severity of Medical Adhesive-Related Skin Injury
Severity of MARSI classified as mild, moderate, or severe according to the Wang et al. grading system.
Time frame
From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).3
Type of Medical Adhesive-Related Skin Injury
Type of medical adhesive-related skin injury (MARSI) classified according to the international consensus as mechanical injury, dermatitis, maceration, folliculitis, or other skin injuries.
Time frame
From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Azize Özdaş Gündoğan
Lead sponsor
Ege University
Sponsor institution
Source ClinicalTrials.gov