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

Sponsor
Institut Català d'Oncologia
Study ID
NCT07697170
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Weekly dressing for peripherally inserted central catheters — PROCEDURE
    dressing changes for peripherally inserted central catheters every week
  • 15 days dressing change for peripherally inserted central catheters — PROCEDURE
    Each 15 days dressing change for peripherally inserted central catheters
  • peripherally inserted central catheters — PROCEDURE
    peripherally inserted central catheters

Study Details

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).

Key Dates

First listed
Jul 13, 2026
Start date
Jun 10, 2026
Status verified
Jul 2026
Primary completion
Oct 1, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
150 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: 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
  • Active Comparator: Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change
    Biweekly Inserted Central Catheters (PICC) dressing change

Primary Outcome Measure

Number of Participants with Medical Adhesive-Related Skin Injury (MARSI) [ Time Frame: - 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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