Medical Adhesive Related Skin InjuryNCT07697430
Medical Adhesive and Barrier Products for Preventing MARSI in Central Venous Catheter Dressings
A study testing Acrylic Adhesive Tape, Silicone Adhesive Tape and Skin Barrier Film + Acrylic Adhesive Tape in people with Medical Adhesive Related Skin Injury and Central Venous Catheter, run by Azize Özdaş Gündoğan at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Adhesive Related Skin Injury, Central Venous Catheter
- What is being tested?
- Acrylic Adhesive Tape, Silicone Adhesive Tape and Skin Barrier Film + Acrylic Adhesive Tape
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Afyonkarahisar Health Sciences University Health Practice and Research Center
Afyonkarahisar, Center, 03030
Azize Ozdas Gundogan, RN, MSc, +90533 615 36 55, azize.ozdas@afsu.edu.tr
Ibrahım Guven Cosgun, MD
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Acrylic Adhesive Tape, Silicone Adhesive Tape, Skin Barrier Film + Acrylic Adhesive Tape
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Skin Barrier Film + Acrylic Adhesive Tape |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Time from catheter dressing application to the first occurrence of medical adhesive-related skin injury.
Measured: From randomization until catheter removal or up to 21 days.
Severity of Medical Adhesive-Related Skin Injury
Severity of MARSI classified as mild, moderate, or severe according to the Wang et al. grading system.
Measured: 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
Type of medical adhesive-related skin injury (MARSI) classified according to the international consensus as mechanical injury, dermatitis, maceration, folliculitis, or other skin injuries.
Measured: From randomization until catheter removal or up to 21 days, assessed at every dressing change (every 24 hours).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jun 2026
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical Adhesive Related Skin InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azize Özdaş Gündoğan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Azize Özdaş Gündoğan, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697430
- Sponsor's protocol ID
- EÜ-SBE-HE-93220000072-CIP-01
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07697430
- Acronym / sponsor ID
- EÜ-SBE-HE-93220000072-CIP-01
- 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
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Azize Özdaş GündoğanUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Acrylic Adhesive Tape | Experimental | Device: Acrylic Adhesive TapeParticipants 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. |
| Silicone Adhesive Tape | Experimental | Device: Silicone Adhesive TapeParticipants 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. |
| Barrier Film + Acrylic Adhesive Tape | Experimental | Device: Skin Barrier Film + Acrylic Adhesive TapeParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acrylic Adhesive TapeA 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. | Device | Acrylic Adhesive Tape |
| Silicone Adhesive TapeA 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. | Device | Silicone Adhesive Tape |
| Skin Barrier Film + Acrylic Adhesive TapeA 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. | Device | Barrier Film + Acrylic Adhesive Tape |
Primary outcome
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).
3 secondary outcomes
Time to First Medical Adhesive-Related Skin Injury
Time frame: 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).
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Afyonkarahisar Health Sciences University Health Practice and Research Center
Afyonkarahisar, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acrylic Adhesive Tape, Silicone Adhesive Tape and Skin Barrier Film + Acrylic Adhesive Tape in people with Medical Adhesive Related Skin Injury and Central Venous Catheter, run by Azize Özdaş Gündoğan at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2026.