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

NCT07697170 | Enrolling By Invitation

• 1 other identifier: ICO-MARSI-01-2025
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Colon Cancer; Cancer Pancreas

Keywords

Vascular access; Medical adhesive-related skin injury; Dressing change frequency; Oncology nursing

Outcome Measures

Primary Outcomes (5)

• Number of Participants with Medical Adhesive-Related Skin Injury (MARSI)

  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.

• Number of Participants with Catheter-related bloodstream infection

  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.

• Number of Participants with Catheter-related thrombosis

  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.

• Number of Participants with Catheter obstruction

  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.

• Number of Participants with Catheter migration or externalization

  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.

Secondary Outcomes (2)

• Patient satisfaction with vascular access care

  Assessment timepoints: at Inserted Central Catheters (PICC) removal

• Patient Quality of life

  Assessment timepoints: baseline, 3 months, 6 months, and at Inserted Central Catheters (PICC) removal

Study Arms (2)

Arm 1: Weekly Dressing Change

PLACEBO COMPARATOR

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

Procedure: Weekly dressing for peripherally inserted central catheters; Procedure: peripherally inserted central catheters

Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change

ACTIVE COMPARATOR

Biweekly Inserted Central Catheters (PICC) dressing change

Procedure: 15 days dressing change for peripherally inserted central catheters; Procedure: peripherally inserted central catheters

Interventions

Weekly dressing for peripherally inserted central catheters PROCEDURE

dressing changes for peripherally inserted central catheters every week

Arm 1: Weekly Dressing Change

peripherally inserted central catheters PROCEDURE

peripherally inserted central catheters

Arm 1: Weekly Dressing Change; Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change

15 days dressing change for peripherally inserted central catheters PROCEDURE

Each 15 days dressing change for peripherally inserted central catheters

Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Catheter-related infection within the previous 30 days
• Known allergy to adhesive dressings
• Raynaud syndrome
• Skin jaundice or cyanosis at baseline

Sponsors & Collaborators

• Institut Català d'Oncologia: lead
• Fundació Institut Germans Trias i Pujol: collaborator
• Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta: collaborator

Study Sites (1)

Sandra Cabrera Jaime

Badalona, Barcelona, 08916, Spain

Location

Related Publications (6)

• 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.

  PMID: 32134695 RESULT

• 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.

  PMID: 32304449 RESULT

• 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.

  PMID: 38561302 RESULT

• 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.

  PMID: 23759927 RESULT

• 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.

  PMID: 36102472 RESULT

• 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.

  PMID: 33016412 RESULT

MeSH Terms

Conditions

Colonic Neoplasms; Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control Group: Weekly PICC dressing change according to institutional vascular access protocol. Intervention Group: Biweekly PICC dressing change every 14 days according to institutional vascular access protocol.

Study Record Dates

• First Submitted: June 22, 2026
• First Posted: July 13, 2026
• Study Start: June 10, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)