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

July 5, 2026 updated by: Azize Özdaş Gündoğan

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

162

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
    • Center
      • Afyonkarahisar, Center, Turkey (Türkiye), 03030
        • Recruiting
        • Afyonkarahisar Health Sciences University Health Practice and Research Center
        • Contact:
        • Principal Investigator:
          • Ibrahım Guven Cosgun, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adults aged 18 years or older. Patients admitted to the Chest Diseases Intensive Care Unit who are undergoing insertion of an internal jugular central venous catheter.

Central venous catheter inserted by a physician using sterile technique in the intensive care unit or operating room.

Intact skin at the catheter insertion site, with no pre-existing skin injury or dermatological disease.

Written informed consent provided by the participant or a legally authorized representative.

Exclusion Criteria:

  • Active or congenital dermatological disease. Known allergy or hypersensitivity to the study dressings or skin barrier film. Clinically significant hyperhidrosis. Central venous catheter inserted through a site other than the internal jugular vein (e.g., subclavian or femoral vein).

Patients requiring contact isolation (e.g., scabies) or airborne isolation (e.g., tuberculosis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
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.
Device: 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.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Medical Adhesive-Related Skin Injury (MARSI)
Time Frame: 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).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Medical Adhesive-Related Skin Injury
Time Frame: 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
Time Frame: 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
Time Frame: 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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azize Özdaş Gündoğan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

July 5, 2026

First Submitted That Met QC Criteria

July 5, 2026

First Posted (Actual)

July 13, 2026

Study Record Updates

Last Update Posted (Actual)

July 13, 2026

Last Update Submitted That Met QC Criteria

July 5, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • EÜ-SBE-HE-93220000072-CIP-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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