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

Condition(s) studied

Investigational drug(s) / intervention(s)

Weekly dressing for peripherally inserted central catheters: dressing changes for peripherally inserted central catheters every week

15 days dressing change for peripherally inserted central catheters: Each 15 days dressing change for peripherally inserted central catheters

peripherally inserted central catheters: peripherally inserted central catheters

Study summary

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).

Eligibility

Primary outcome measure(s)

• Number of Participants with Medical Adhesive-Related Skin Injury (MARSI) — - 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).
• Number of Participants with Catheter-related bloodstream infection — - 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).
• Number of Participants with Catheter-related thrombosis — - 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).
• Number of Participants with Catheter obstruction — - 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).
• Number of Participants with Catheter migration or externalization — - 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).

Trial sites (1)

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