Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Number of Participants with Medical Adhesive-Related Skin Injury (MARSI)
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Catheter-related infection within the previous 30 days
- •Known allergy to adhesive dressings
- •Raynaud syndrome
- •Skin jaundice or cyanosis at baseline
研究组 & 干预措施
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
干预措施: Weekly dressing for peripherally inserted central catheters (Procedure)
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
干预措施: peripherally inserted central catheters (Procedure)
Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change
Biweekly Inserted Central Catheters (PICC) dressing change
干预措施: 15 days dressing change for peripherally inserted central catheters (Procedure)
Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change
Biweekly Inserted Central Catheters (PICC) dressing change
干预措施: peripherally inserted central catheters (Procedure)
结局指标
主要结局
Number of Participants with Medical Adhesive-Related Skin Injury (MARSI)
时间窗: - 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
时间窗: - 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
时间窗: - 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
时间窗: - 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
时间窗: - 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).
次要结局
- 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)