NCT07697430

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Jun 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress17%
Jun 2026Jun 2027

Study Start

First participant enrolled

June 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 5, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 13, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 5, 2026

Last Update Submit

July 19, 2026

Conditions

Medical Adhesive Related Skin InjuryCentral Venous Catheter

Keywords

MARSIMedical Adhesive Related Skin InjuryCentral Venous CatheterCentral Venous Catheter DressingAcrylic Adhesive TapeSilicone Adhesive TapeBarrier FilmIntensive Care UnitNursingSkin InjuryRandomized Controlled Trialmedical adhesive tapesCentral venous catheter dressing fixation

Outcome Measures

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).

    From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).

Secondary Outcomes (3)

  • Time to First Medical Adhesive-Related Skin Injury

    From randomization until catheter removal or up to 21 days.

  • 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).

  • 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).

Study Arms (3)

Acrylic Adhesive Tape

EXPERIMENTAL

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

Silicone Adhesive Tape

EXPERIMENTAL

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

Barrier Film + Acrylic Adhesive Tape

EXPERIMENTAL

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

Interventions

Acrylic Adhesive TapeDEVICE

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.

Acrylic Adhesive Tape
Silicone Adhesive TapeDEVICE

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.

Silicone Adhesive Tape
Skin Barrier Film + Acrylic Adhesive TapeDEVICE

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.

Barrier Film + Acrylic Adhesive Tape

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University Health Practice and Research Center

Afyonkarahisar, Center, 03030, Turkey (Türkiye)

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PhD Candidate, Department of Fundamentals of Nursing

Study Record Dates

First Submitted

July 5, 2026

First Posted

July 13, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)