Frequency of Care for Peripherally Inserted Central Vascular Access In the Prevention of Marsi (ICO-MARSI)
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.
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).
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究場所
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Barcelona
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Badalona、Barcelona、スペイン、08916
- Sandra Cabrera Jaime
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター：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 |
dressing changes for peripherally inserted central catheters every week
peripherally inserted central catheters
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アクティブコンパレータ：Arm 2. Biweekly Inserted Central Catheters (PICC) dressing change
Biweekly Inserted Central Catheters (PICC) dressing change
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peripherally inserted central catheters
Each 15 days dressing change for peripherally inserted central catheters
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants with Medical Adhesive-Related Skin Injury (MARSI)
時間枠：- 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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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.
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Number of Participants with Catheter-related bloodstream infection
時間枠：- 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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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.
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Number of Participants with Catheter-related thrombosis
時間枠：- 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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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.
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Number of Participants with Catheter obstruction
時間枠：- 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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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.
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Number of Participants with Catheter migration or externalization
時間枠：- 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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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.
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient satisfaction with vascular access care
時間枠：Assessment timepoints: at Inserted Central Catheters (PICC) removal
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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).
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Assessment timepoints: at Inserted Central Catheters (PICC) removal
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Patient Quality of life
時間枠：Assessment timepoints: baseline, 3 months, 6 months, and at Inserted Central Catheters (PICC) removal
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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.
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Assessment timepoints: baseline, 3 months, 6 months, and at Inserted Central Catheters (PICC) removal
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協力者と研究者
出版物と役立つリンク
一般刊行物
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- ICO-MARSI-01-2025
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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結腸がんの臨床試験
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Novartis Pharmaceuticals終了しましたメラノーマ | 高度なEGFR変異体非小さな細胞肺cancer（NSCLC） | KRAS G12変異NSCLC | 食道扁平上皮がん（SCC） | ヘッド/ネックSCC | 進行した胃腸間質腫瘍（GIST） | 進行したNRAS/BRAFT WT皮膚黒色腫アメリカ, 台湾, オランダ, カナダ, スペイン, シンガポール, イタリア, 日本, 韓国
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); Highlight Therapeutics積極的、募集していない平滑筋肉腫 | 悪性末梢神経鞘腫瘍 | 滑膜肉腫 | 未分化多形肉腫 | 骨の未分化高悪性度多形肉腫 | 粘液線維肉腫 | II期の体幹および四肢の軟部肉腫 AJCC v8 | III期の体幹および四肢の軟部肉腫 AJCC v8 | IIIA 期の体幹および四肢の軟部肉腫 AJCC v8 | IIIB 期の体幹および四肢の軟部肉腫 AJCC v8 | 切除可能な軟部肉腫 | 多形性横紋筋肉腫 | 切除可能な脱分化型脂肪肉腫 | 切除可能な未分化多形肉腫 | 軟部組織線維肉腫 | 紡錘細胞肉腫 | ステージ I 後腹膜肉腫 AJCC (American Joint Committee on Cancer) v8 | 体幹および四肢の I 期軟部肉腫 AJCC v8 | ステージ... およびその他の条件アメリカ
Weekly dressing for peripherally inserted central cathetersの臨床試験
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Angiodynamics, Inc.終了しました