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

19 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

162

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Turchia (Türkiye)
    • Center
      • Afyonkarahisar, Center, Turchia (Türkiye), 03030
        • Reclutamento
        • Afyonkarahisar Health Sciences University Health Practice and Research Center
        • Contatto:
        • Investigatore principale:
          • Ibrahım Guven Cosgun, MD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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).

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Prevenzione
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Dispositivo: 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.
Sperimentale: 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.
Dispositivo: 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.
Sperimentale: 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.
Dispositivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Incidence of Medical Adhesive-Related Skin Injury (MARSI)
Lasso di tempo: 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).

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to First Medical Adhesive-Related Skin Injury
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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).

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Azize Özdaş Gündoğan

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2026

Completamento primario (Stimato)

1 giugno 2027

Completamento dello studio (Stimato)

1 giugno 2027

Date di iscrizione allo studio

Primo inviato

5 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

21 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

19 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • EÜ-SBE-HE-93220000072-CIP-01

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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