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Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi (ICO-MARSI)

6 lipca 2026 zaktualizowane przez: Institut Català d'Oncologia

Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi: A Randomized Clinical Trial

This randomized controlled clinical trial evaluates the safety equivalence between weekly and biweekly dressing changes for peripherally inserted central catheters (PICC) in oncology patients receiving outpatient chemotherapy.

The study will assess vascular access functionality, skin integrity including Medical Adhesive-Related Skin Injury (MARSI), and the incidence of catheter-related complications.

A total of 150 adult patients with colon or pancreas cancer receiving chemotherapy and requiring PICC insertion will be randomized into two groups: weekly dressing changes (control group) or biweekly dressing changes every 14 days (intervention group).

Participants will be followed during chemotherapy treatment for a minimum of six cycles and up to twelve sessions. Outcomes include catheter-related complications, patient satisfaction with vascular access care, and quality of life measured using the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire).

Przegląd badań

Status

Rejestracja na zaproszenie

Warunki

Interwencja / Leczenie

Szczegółowy opis

Peripherally inserted central catheters (PICC) are frequently used in oncology patients to administer chemotherapy and other intravenous therapies.

Adhesive dressings are commonly used to secure the catheter and allow visualization of the insertion site. However, adhesive medical products may cause Medical Adhesive-Related Skin Injury (MARSI), particularly in patients with fragile skin due to cancer treatments or advanced age.

Current clinical practice usually recommends weekly dressing changes, mainly based on manufacturer recommendations rather than strong clinical evidence.

Frequent dressing replacement may increase the risk of skin injury due to repeated manipulation of fragile skin.

This randomized controlled trial aims to evaluate whether extending the dressing change interval to 14 days provides equivalent safety compared with weekly changes in terms of vascular access functionality, skin integrity, and complication rates.

The study will be conducted at the Institut Català d'Oncologia (ICO) in Badalona and Girona, Spain.

Estimated Enrollment 150 participants. Inclusion Criteria: Adults aged 18 years or older, Diagnosis of colon or pancreas cancer, Indication for PICC insertion for chemotherapy administration Chemotherapy regimen including FOLFOX6 (Oxaliplatin + 5-FU + Folinic acid), FOLFOX4, FOLFIRI (Irinotecan + 5-FU + Folinic acid) or mFOLFIRI, Ability to understand the study and provide written informed consent.

Primary Outcome Measure: Presence of catheter-related complications including Medical Adhesive-Related Skin Injury (MARSI), Catheter-related bloodstream infection, Catheter obstruction, Catheter migration or externalization, Catheter-related thrombosis.

Time Frame: From PICC insertion (Baseline) until catheter removal or completion of chemotherapy treatment (maximum 12 chemotherapy sessions or 168 days).

Secondary Outcome Measures: Type of catheter-related complications including classification of MARSI lesions (erythema, vesicle, blister, erosion, or skin tear). Patient satisfaction with vascular access care measured using a numerical satisfaction scale ranging from 0 to 10. Quality of life measured using the EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire). Assessment timepoints: baseline, 3 months, 6 months, and at PICC removal.

Follow-Up: Participants will be followed during chemotherapy treatment for a minimum of 6 cycles and up to 12 chemotherapy sessions (168 days).

Clinical monitoring will include evaluation of catheter functionality, skin integrity, catheter-related complications, patient satisfaction, and quality of life.

Statistical Analysis: Data will be collected using REDCap and analyzed using IBM SPSS statistical software. The analysis will include: Descriptive statistics Chi-square or Fisher's exact test for categorical variables Student t-test or Mann-Whitney test for comparison of means ANOVA or Kruskal-Wallis tests Kaplan-Meier survival analysis Cox proportional hazards regression models Statistical significance will be set at p < 0.05.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

150

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Hiszpania
    • Barcelona
      • Badalona, Barcelona, Hiszpania, 08916
        • Sandra Cabrera Jaime

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

Inclusion Criteria:

  • Age ≥18 years
  • Diagnosis of colon or pancreas cancer
  • Indication for PICC insertion for chemotherapy administration
  • Chemotherapy regimen including FOLFOX6, FOLFOX4, FOLFIRI, or mFOLFIRI
  • Ability to understand the study procedures
  • Signed written informed consent

Exclusion Criteria:

  • Catheter-related infection within the previous 30 days
  • Known allergy to adhesive dressings
  • Raynaud syndrome
  • Skin jaundice or cyanosis at baseline

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Arm 1: Weekly Dressing Change

Participants will receive standard Inserted Central Catheters (PICC) care consisting of weekly dressing replacement according to the institutional vascular access care protocol using aseptic technique.

Intervention Type: Procedure Intervention Name: Weekly PICC Dressing Change
Procedura: Weekly dressing for peripherally inserted central catheters
dressing changes for peripherally inserted central catheters every week
Procedura: peripherally inserted central catheters
peripherally inserted central catheters
Aktywny komparator: Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change
Biweekly Inserted Central Catheters (PICC) dressing change
Procedura: peripherally inserted central catheters
peripherally inserted central catheters
Procedura: 15 days dressing change for peripherally inserted central catheters
Each 15 days dressing change for peripherally inserted central catheters

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of Participants with Medical Adhesive-Related Skin Injury (MARSI)
Ramy czasowe: - Control group: Baseline, every 1 week until 24 weeks or end of systemic treatment, whichever occurs first. - Intervention group: baseline, every 2 week until 24 weeks or end of systemic treatment, whichever occurs first.

MARSI (Medical Adhesive-Related Skin Injury): a skin injury caused by a medical adhesive, presenting as erythema and/or any other abnormal skin manifestation (vesicle, blister, erosion, or skin tear) that persists 30 minutes after the dressing has been applied or removed (10).

MARSI injury types: Erythema: redness and inflammation. Vesicle: fluid-filled sac in the outer layer of the skin <5 mm. Blister: fluid-filled sac in the outer layer of the skin >5 mm. Erosion: skin lesions characterized by the loss of the epidermis, the outermost layer of the skin. Skin tear: wounds in which the skin separates from its original position, often due to shear forces, friction, or blunt trauma.

Evaluation method: direct observation by the nurse

The patient will undergo a total follow-up period of 24 weeks (168 days), spanning from Inserted Central Catheters (PICC) insertion (Baseline) to catheter removal or completion of chemotherapy treatment (maximum 12 chemotherapy sessions).
- Control group: Baseline, every 1 week until 24 weeks or end of systemic treatment, whichever occurs first. - Intervention group: baseline, every 2 week until 24 weeks or end of systemic treatment, whichever occurs first.
Number of Participants with Catheter-related bloodstream infection
Ramy czasowe: - Control group: Baseline, every 1 week until 24 weeks or end of systemic treatment, whichever occurs first. - Intervention group: baseline, every 2 week until 24 weeks or end of systemic treatment, whichever occurs first.

Assessment method: direct observation of warning signs (fever ≥ 38°C or hypothermia, severe chills and tachycardia, presence of purulent exudate, etc. ) by the nurse in charge of care. In cases of suspected infection, exit-site cultures and blood cultures are obtained.

Diagnostic criteria: 1. Catheter-related bacteremia according to VINCAT criteria (https://pubmed.ncbi.nlm.nih.gov/22776147/). 2. Microorganism causing the infection (only in cases of infection) The patient will undergo a total follow-up period of 24 weeks (168 days), spanning from Inserted Central Catheters (PICC) insertion (Baseline) to catheter removal or completion of chemotherapy treatment (maximum 12 chemotherapy sessions).
- Control group: Baseline, every 1 week until 24 weeks or end of systemic treatment, whichever occurs first. - Intervention group: baseline, every 2 week until 24 weeks or end of systemic treatment, whichever occurs first.
Number of Participants with Catheter-related thrombosis
Ramy czasowe: - Control group: Baseline, every 1 week until 24 weeks or end of systemic treatment, whichever occurs first. - Intervention group: baseline, every 2 week until 24 weeks or end of systemic treatment, whichever occurs first.

Evaluation method: direct observation of warning signs by the nurse in charge of care (pain, erythema, edema, etc.).

Diagnosed via radiology Doppler ultrasound: yes/no. Details specified: vein location, size, and anticoagulant treatment (dose and duration).

The patient will undergo a total follow-up period of 24 weeks (168 days), spanning from Inserted Central Catheters (PICC) insertion (Baseline) to catheter removal or completion of chemotherapy treatment (maximum 12 chemotherapy sessions).
- Control group: Baseline, every 1 week until 24 weeks or end of systemic treatment, whichever occurs first. - Intervention group: baseline, every 2 week until 24 weeks or end of systemic treatment, whichever occurs first.
Number of Participants with Catheter obstruction
Ramy czasowe: - Control group: Baseline, every 1 week until 24 weeks or end of systemic treatment, whichever occurs first. - Intervention group: baseline, every 2 week until 24 weeks or end of systemic treatment, whichever occurs first.

Lack of patency to normal saline or absence of reflux. Diagnostic method: aspiration and flushing of the catheter with normal saline during standard care.

The patient will undergo a total follow-up period of 24 weeks (168 days), spanning from Inserted Central Catheters (PICC) insertion (Baseline) to catheter removal or completion of chemotherapy treatment (maximum 12 chemotherapy sessions).
- Control group: Baseline, every 1 week until 24 weeks or end of systemic treatment, whichever occurs first. - Intervention group: baseline, every 2 week until 24 weeks or end of systemic treatment, whichever occurs first.
Number of Participants with Catheter migration or externalization
Ramy czasowe: - Control group: Baseline, every 1 week until 24 weeks or end of systemic treatment, whichever occurs first. - Intervention group: baseline, every 2 week until 24 weeks or end of systemic treatment, whichever occurs first.

Migration/externalization: >4 cm outward displacement, catheter tip non-central. Diagnostic method: direct observation by the nurse in charge during care and measurement with a sterile tape measure.

The patient will undergo a total follow-up period of 24 weeks (168 days), spanning from Inserted Central Catheters (PICC) insertion (Baseline) to catheter removal or completion of chemotherapy treatment (maximum 12 chemotherapy sessions).
- Control group: Baseline, every 1 week until 24 weeks or end of systemic treatment, whichever occurs first. - Intervention group: baseline, every 2 week until 24 weeks or end of systemic treatment, whichever occurs first.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patient satisfaction with vascular access care
Ramy czasowe: Assessment timepoints: at Inserted Central Catheters (PICC) removal
Ad hoc direct administration satisfaction questionnaire a 6-question survey regarding vascular access care using a numerical scale ranging from 0 to 10 (extremely dissatisfied / very satisfied).
Assessment timepoints: at Inserted Central Catheters (PICC) removal
Patient Quality of life
Ramy czasowe: Assessment timepoints: baseline, 3 months, 6 months, and at Inserted Central Catheters (PICC) removal
Quality of life EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire): A self-administered scale for assessing the perception of quality of life, a 30-item psychometric test developed by the European Organisation for Research and Treatment of Cancer (EORTC).Scores on the EORTC QLQ-C30 scale are standardized to a range of 0 to 100 for all sections. The meaning of the score depends on the category being evaluated: Functional Scales and Global Health Status: A higher score indicates better functioning and a higher quality of life. Symptom and Difficulty Scales: A higher score indicates greater symptom severity (such as fatigue or pain) and a greater negative impact.
Assessment timepoints: baseline, 3 months, 6 months, and at Inserted Central Catheters (PICC) removal

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Institut Català d'Oncologia

Współpracownicy

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
Fundació Institut Germans Trias i Pujol

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

10 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 października 2027

Ukończenie studiów (Szacowany)

1 lutego 2028

Daty rejestracji na studia

Pierwszy przesłany

22 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

6 lipca 2026

Pierwszy wysłany (Rzeczywisty)

13 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

13 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

6 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • ICO-MARSI-01-2025

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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