Clinical trial · Interventional
Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi
Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi: A Randomized Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Pancreas | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 15 days dressing change for peripherally inserted central catheters | Procedure | — | UNRESOLVED |
| peripherally inserted central catheters | Procedure | — | UNRESOLVED |
| Weekly dressing for peripherally inserted central catheters | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Arm 1: Weekly Dressing Change
- description
- 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
- interventionNames
- Procedure: Weekly dressing for peripherally inserted central catheters
- Procedure: peripherally inserted central catheters
- type
- ACTIVE_COMPARATOR
- label
- Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change
- description
- Biweekly Inserted Central Catheters (PICC) dressing change
- interventionNames
- Procedure: 15 days dressing change for peripherally inserted central catheters
- Procedure: peripherally inserted central catheters
Primary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- RESULTFumarola 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. PMID 32134695
- RESULTZhang 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. PMID 32304449
- RESULTJi 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. PMID 38561302
- RESULTMcNichol 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. PMID 23759927
- RESULTRabelo 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. PMID 36102472
- RESULTMarsh 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. PMID 33016412