Pilot Study on the Effectiveness of Novel Peripherally Inserted Central Catheter (PICC) Securement Dressing in Preventing PICC Dislodgement
2026年9月8日 更新者：Changi General Hospital
Evidence regarding clinical effectiveness and acceptability of PICC sleeves remain limited.
Few randomised controlled trials have evaluated PICC sleeves in routine hospital practice, and there is limited evidence regarding their feasibility, safety and influence on line condition.
This pilot randomised controlled trial aims to evaluate the feasibility, safety, and user experience of a protective PICC sleeve among hospitalised patients with PICCs.
調査の概要
研究の種類
介入
入学 (実際)
67
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Singapore、シンガポール、529889
- Changi General Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Adult patients receiving PICC placement for various medical conditions
Exclusion Criteria:
- Patients with known allergies to materials in the PICC sleeve
- Patients contraindicated for PICC placement
- Patients who are aggressive and/or restless
- Patients whose skin condition is unsuitable for CHG gel dressing application (e.g. skin with eczema plaques, bullous pemphigoid)
- Patients who have no mental capacity to give consent
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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介入なし：The control group
The control group used the standard securement dressing
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実験的：The Treatment group
The treatment group received appropriately sized PICC sleeve cover in addition to standard device securement practices.
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The novel PICC sleeve cover would be applied on the intervention group in addition to standard PICC securement practices.
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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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Participant Recruitment Rate
時間枠：16 months
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Number of participants recruited over the recruitment period
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16 months
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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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Intervention Adherence
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Percentage of participants who were compliant to wearing the PICC sleeve cover
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Retention of Study Participants across 3 Time-points
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Number of study participants across 3 time-points (2 days after PICC insertion, 14 days after PICC insertion or upon removal, whichever earlier, and 7 days after discharge from hospital) presented as a percentage of the original number of study participants in each arm
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Completeness of Data Collected
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Percentage of data collected over the ideal number of data to be collected
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Number of Adverse Events
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Percentage of participants suffering from adverse events over the total number of participants
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Patient-Reported Dislodgement Risk
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Mean score of all participants rating their perceived dislodgement risk on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Patient-Reported Comfort Level
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Mean score of all participants rating their perceived comfort level on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Patient-Reported Visibility Level
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Mean score of all participants rating their perceived visibility level on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm.
The visibility level refers to the degree the PICC dressing is exposed to the onlookers and how that may affect their own self-image.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Patient-Reported User-friendliness
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Mean score of all participants rating their perceived user-friendliness of the PICC dressing on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Patient-Reported Acceptability Outcome
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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The mean of the mean scores for patient-reported dislodgement risk, comfort level, visibility level and user-friendliness.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Staff-Reported Dislodgement Risk
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Mean score of all participants rating their patients' perceived dislodgement risk on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Staff-Reported Comfort Level
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Mean score of all participants rating their patients' perceived comfort level on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Staff-Reported Visibility Level
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Mean score of all participants rating their patient's perceived visibility level on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm.
The visibility level refers to the degree the PICC dressing is exposed to the onlookers and how that may affect their own self-image.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Staff-Reported User-friendliness
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Mean score of all participants rating their patient's perceived user-friendliness of the PICC dressing on a self-designed questionnaire from 1 (strongly disagree) to 5 (strongly agree) in each study arm.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Staff-Reported Acceptability Outcome
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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The mean of the mean scores for staff-reported dislodgement risk, comfort level, visibility level and user-friendliness.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Dislodgement Cases
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Number of dislodgement cases (complete/partial)
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Dressing Condition
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Percentage of participants with intact dressing or dressing with some peeling over the total number of participants in each arm.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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CHG Gel Condition
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Percentage of participants with intact CHG gel or CHG gel with some swelling over the total number of participants in each arm.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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External Length
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Percentage of participants with the same or minimally changed (< 2cm) external length of PICC over the total number of participants in each arm.
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Patency of PICC Lumens
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Percentage of participants whose PICC are still patent with or without backflow over the total number of participants in each arm
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Insertion Site
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Percentage of participants without any redness, slough or necrotic tissue at the insertion site over the total number of participants in each arm
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Discharge from PICC insertion site
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Percentage of participants with no discharge from the PICC insertion site over the total number of participants in each arm
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Surrounding Skin around PICC Insertion Site
時間枠：From enrolment to 7 days after discharge or upon removal, whichever earlier.
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Percentage of participants with nil redness of surrounding skin around the PICC insertion site over the total number of participants in each arm
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From enrolment to 7 days after discharge or upon removal, whichever earlier.
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Chan RJ, Northfield S, Larsen E, Mihala G, Ullman A, Hancock P, Marsh N, Gavin N, Wyld D, Allworth A, Russell E, Choudhury MA, Flynn J, Rickard CM. Central venous Access device SeCurement And Dressing Effectiveness for peripherally inserted central catheters in adult acute hospital patients (CASCADE): a pilot randomised controlled trial. Trials. 2017 Oct 4;18(1):458. doi: 10.1186/s13063-017-2207-x.
- O'Grady NP, Alexander M, Burns LA, Dellinger EP, Garland J, Heard SO, Lipsett PA, Masur H, Mermel LA, Pearson ML, Raad II, Randolph AG, Rupp ME, Saint S; Healthcare Infection Control Practices Advisory Committee (HICPAC) (Appendix 1). Summary of recommendations: Guidelines for the Prevention of Intravascular Catheter-related Infections. Clin Infect Dis. 2011 May;52(9):1087-99. doi: 10.1093/cid/cir138. No abstract available.
- Karpanen T, Casey A, Whitehouse T, Nightingale P, Das I, Elliott TS. Abstracts from the 3rd International Conference on Prevention and Infection Control (ICPIC 2015). Antimicrob Resist Infect Control. 2015 Jun 16;4 Suppl 1(Suppl 1):I1-P308. doi: 10.1186/2047-2994-4-s1-i1. No abstract available.
- Dong H, Zhu Y, Zhang X, Yin X, Liu F. Chest CT tomography vs. intracavitary electrocardiogram guidance in predicting the length of PICC placement. BMC Surg. 2022 May 19;22(1):197. doi: 10.1186/s12893-022-01604-0.
- Grau D, Clarivet B, Lotthe A, Bommart S, Parer S. Complications with peripherally inserted central catheters (PICCs) used in hospitalized patients and outpatients: a prospective cohort study. Antimicrob Resist Infect Control. 2017 Jan 28;6:18. doi: 10.1186/s13756-016-0161-0. eCollection 2017.
- Moureau N, Lamperti M, Kelly LJ, Dawson R, Elbarbary M, van Boxtel AJ, Pittiruti M. Evidence-based consensus on the insertion of central venous access devices: definition of minimal requirements for training. Br J Anaesth. 2013 Mar;110(3):347-56. doi: 10.1093/bja/aes499. Epub 2013 Jan 29.
- Yu K, Li J, Zhang D, Liu B, Wang K, Liu W, Shi Y, Zhao Y, Liu Y, Guo N, Sun W. Types of peripherally inserted central catheters and the risk of unplanned removals in patients: A prospective cohort study. Int J Nurs Stud. 2024 Jan;149:104621. doi: 10.1016/j.ijnurstu.2023.104621. Epub 2023 Oct 12.
- Xu B, Zhang J, Hou J, Ma M, Gong Z, Tang S. Nurses' Attitudes and Knowledge of Peripherally Inserted Central Catheter Maintenance in Primary Hospitals in China: A Cross-Sectional Survey. Risk Manag Healthc Policy. 2020 Jul 28;13:903-913. doi: 10.2147/RMHP.S250741. eCollection 2020.
- Rickard CM, Marsh NM, Webster J, Gavin NC, Chan RJ, McCarthy AL, Mollee P, Ullman AJ, Kleidon T, Chopra V, Zhang L, McGrail MR, Larsen E, Choudhury MA, Keogh S, Alexandrou E, McMillan DJ, Mervin MC, Paterson DL, Cooke M, Ray-Barruel G, Castillo MI, Hallahan A, Corley A, Geoffrey Playford E. Peripherally InSerted CEntral catheter dressing and securement in patients with cancer: the PISCES trial. Protocol for a 2x2 factorial, superiority randomised controlled trial. BMJ Open. 2017 Jun 15;7(6):e015291. doi: 10.1136/bmjopen-2016-015291.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2024年3月21日
一次修了 (実際)
2025年7月10日
研究の完了 (実際)
2025年9月25日
試験登録日
最初に提出
2026年9月2日
QC基準を満たした最初の提出物
2026年9月8日
最初の投稿 (実際)
2026年9月14日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月14日
QC基準を満たした最後の更新が送信されました
2026年9月8日
最終確認日
2025年9月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- 2024-2117
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?
いいえ
IPD プランの説明
Legal/Regulatory: Data protection laws, consent limitations, institutional policies
Commercial: Proprietary concerns, competitive advantage, patent issues
Ethical: Privacy concerns, insufficient original consent, ethics approval scope
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いいえ
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いいえ
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