Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi

Brief summary public domain (ClinicalTrials.gov)

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).

Detailed description public domain (ClinicalTrials.gov)

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.