Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi (ICO-MARSI)
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).
Descripción general del estudio
Estado
Condiciones
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Barcelona
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Badalona, Barcelona, España, 08916
- Sandra Cabrera Jaime
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador de placebos: 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 |
dressing changes for peripherally inserted central catheters every week
peripherally inserted central catheters
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Comparador activo: Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change
Biweekly Inserted Central Catheters (PICC) dressing change
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peripherally inserted central catheters
Each 15 days dressing change for peripherally inserted central catheters
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants with Medical Adhesive-Related Skin Injury (MARSI)
Periodo de tiempo: - 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.
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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.
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Number of Participants with Catheter-related bloodstream infection
Periodo de tiempo: - 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.
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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.
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Number of Participants with Catheter-related thrombosis
Periodo de tiempo: - 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.
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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.
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Number of Participants with Catheter obstruction
Periodo de tiempo: - 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.
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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.
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Number of Participants with Catheter migration or externalization
Periodo de tiempo: - 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.
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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.
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient satisfaction with vascular access care
Periodo de tiempo: Assessment timepoints: at Inserted Central Catheters (PICC) removal
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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).
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Assessment timepoints: at Inserted Central Catheters (PICC) removal
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Patient Quality of life
Periodo de tiempo: Assessment timepoints: baseline, 3 months, 6 months, and at Inserted Central Catheters (PICC) removal
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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.
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Assessment timepoints: baseline, 3 months, 6 months, and at Inserted Central Catheters (PICC) removal
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Colaboradores e Investigadores
Publicaciones y enlaces útiles
Publicaciones Generales
- Fumarola S, Allaway R, Callaghan R, Collier M, Downie F, Geraghty J, Kiernan S, Spratt F, Bianchi J, Bethell E, Downe A, Griffin J, Hughes M, King B, LeBlanc K, Savine L, Stubbs N, Voegeli D. Overlooked and underestimated: medical adhesive-related skin injuries. J Wound Care. 2020 Mar 1;29(Sup3c):S1-S24. doi: 10.12968/jowc.2020.29.Sup3c.S1. No abstract available.
- Zhang Y, Wang S, Zhang X, Zhang W, Wang X. Incidence and Influencing Factors of Medical Adhesive-Related Skin Injury in Critically Ill Patients. Adv Skin Wound Care. 2020 May;33(5):260-266. doi: 10.1097/01.ASW.0000658584.09988.fa.
- Ji F, Li D, Lyu T, Yang T, Yuan H, Huang X, Hu X. Iatrogenic skin injuries in infants admitted to neonatal intensive care units: An investigation in 22 Chinese units. J Tissue Viability. 2024 May;33(2):197-201. doi: 10.1016/j.jtv.2024.03.007. Epub 2024 Mar 27.
- McNichol L, Lund C, Rosen T, Gray M. Medical adhesives and patient safety: state of the science: consensus statements for the assessment, prevention, and treatment of adhesive-related skin injuries. J Wound Ostomy Continence Nurs. 2013 Jul-Aug;40(4):365-80; quiz E1-2. doi: 10.1097/WON.0b013e3182995516.
- Rabelo AL, Bordonal J, Almeida TL, Oliveira PP, Moraes JT. Medical adhesive-related skin injury in adult intensive care unit: scoping review. Rev Bras Enferm. 2022 Sep 9;75(6):e20210926. doi: 10.1590/0034-7167-2021-0926. eCollection 2022.
- Marsh N, Webster J, Ullman AJ, Mihala G, Cooke M, Chopra V, Rickard CM. Peripheral intravenous catheter non-infectious complications in adults: A systematic review and meta-analysis. J Adv Nurs. 2020 Dec;76(12):3346-3362. doi: 10.1111/jan.14565. Epub 2020 Oct 5.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Neoplasias por sitio
- Neoplasias
- Enfermedades intestinales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias colorrectales
- Neoplasias Intestinales
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Enfermedades del Colon
- Neoplasias colónicas
- Neoplasias pancreáticas
Otros números de identificación del estudio
- ICO-MARSI-01-2025
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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