Colon CancerICO-MARSINCT07697170
Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi
A study testing Weekly dressing for peripherally inserted central catheters, 15 days dressing change for peripherally inserted central catheters and peripherally inserted central catheters in people with Colon Cancer and Cancer Pancreas, run by Institut Català d'Oncologia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer, Cancer Pancreas
- What is being tested?
- Weekly dressing for peripherally inserted central catheters, 15 days dressing change for peripherally inserted central catheters and peripherally inserted central catheters
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2026to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Catheter-related infection within the previous 30 days
- Known allergy to adhesive dressings
- Raynaud syndrome
- Skin jaundice or cyanosis at baseline
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi: A Randomized Clinical Trial
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.
Read more
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).
Read the detailed description
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.
- Conditions
- Colon Cancer, Cancer Pancreas
- Being tested
- Weekly dressing for peripherally inserted central catheters, 15 days dressing change for peripherally inserted central catheters, peripherally inserted central catheters
- Keywords
- Vascular access, Medical adhesive-related skin injury, Dressing change frequency, Oncology nursing
- Medical subject headings
- Colonic Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly dressing for peripherally inserted central cathetersProcedure or surgery
dressing changes for peripherally inserted central catheters every week
15 days dressing change for peripherally inserted central cathetersProcedure or surgery
Each 15 days dressing change for peripherally inserted central catheters
peripherally inserted central cathetersProcedure or surgery
peripherally inserted central catheters
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: 15 days dressing change for peripherally inserted central catheters; Procedure: peripherally inserted central catheters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: - 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).
Measured: - 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).
Measured: - 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).
Measured: - 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).
Measured: - 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
Ad hoc direct administration satisfaction questionnaire a 6-question survey regarding vascular access care using a numerical scale ranging from 0 to 10 (extremely dissatisfied / very satisfied).
Measured: Assessment timepoints: at Inserted Central Catheters (PICC) removal
Patient Quality of life
Quality of life EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire): A self-administered scale for assessing the perception of quality of life, a 30-item psychometric test developed by the European Organisation for Research and Treatment of Cancer (EORTC).Scores on the EORTC QLQ-C30 scale are standardized to a range of 0 to 100 for all sections. The meaning of the score depends on the category being evaluated: Functional Scales and Global Health Status: A higher score indicates better functioning and a higher quality of life. Symptom and Difficulty Scales: A higher score indicates greater symptom severity (such as fatigue or pain) and a greater negative impact.
Measured: Assessment timepoints: baseline, 3 months, 6 months, and at Inserted Central Catheters (PICC) removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Jun 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07697170
- Sponsor's protocol ID
- ICO-MARSI-01-2025
- Acronym
- ICO-MARSI
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32134695Zhang 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.
PubMed 32304449Ji 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.
PubMed 38561302McNichol 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.
PubMed 23759927Rabelo 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.
PubMed 36102472Marsh 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.
PubMed 33016412
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07697170
- Acronym / sponsor ID
- ICO-MARSI / ICO-MARSI-01-2025
- Conditions
- Colon Cancer, Cancer Pancreas
- Keywords
- Vascular access, Medical adhesive-related skin injury, Dressing change frequency, Oncology nursing
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Collaborators
- Fundació Institut Germans Trias i Pujol, Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Weekly Dressing Change | Placebo comparator | Procedure: Weekly dressing for peripherally inserted central catheters, Procedure: peripherally inserted central cathetersParticipants 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 |
| Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change | Active comparator | Procedure: 15 days dressing change for peripherally inserted central catheters, Procedure: peripherally inserted central cathetersBiweekly Inserted Central Catheters (PICC) dressing change |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- Catheter-related infection within the previous 30 days
- Known allergy to adhesive dressings
- Raynaud syndrome
- Skin jaundice or cyanosis at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weekly dressing for peripherally inserted central cathetersdressing changes for peripherally inserted central catheters every week | Procedure or surgery | Arm 1: Weekly Dressing Change |
| 15 days dressing change for peripherally inserted central cathetersEach 15 days dressing change for peripherally inserted central catheters | Procedure or surgery | Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change |
| peripherally inserted central cathetersperipherally inserted central catheters | Procedure or surgery | Arm 1: Weekly Dressing Change, Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change |
Primary outcome
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.
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
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.
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
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.
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
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.
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
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.
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).
2 secondary outcomes
Patient satisfaction with vascular access care
Time frame: Assessment timepoints: at Inserted Central Catheters (PICC) removal
Patient Quality of life
Time frame: Assessment timepoints: baseline, 3 months, 6 months, and at Inserted Central Catheters (PICC) removal
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Results publication: PubMed 32134695Fumarola 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.
- Results publication: PubMed 32304449Zhang 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.
- Results publication: PubMed 38561302Ji 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.
- Results publication: PubMed 23759927McNichol 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.
- Results publication: PubMed 36102472Rabelo 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.
- Results publication: PubMed 33016412Marsh 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly dressing for peripherally inserted central catheters, 15 days dressing change for peripherally inserted central catheters and peripherally inserted central catheters in people with Colon Cancer and Cancer Pancreas, run by Institut Català d'Oncologia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07697170, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.