Pilot Study on the Effectiveness of Novel Peripherally Inserted Central Catheter (PICC) Securement Dressing in Preventing PICC Dislodgement
8 сентября 2026 г. обновлено: 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.
Обзор исследования
Статус
Завершенный
Условия
Вмешательство/лечение
Тип исследования
Интервенционный
Регистрация (Действительный)
67
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
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Singapore, Сингапур, 529889
- Changi General Hospital
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Профилактика
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Без вмешательства: The control group
The control group used the standard securement dressing
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Экспериментальный: 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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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Participant Recruitment Rate
Временное ограничение: 16 months
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Number of participants recruited over the recruitment period
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16 months
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Intervention Adherence
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Number of Dislodgement Cases
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Публикации и полезные ссылки
Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.
Общие публикации
- 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.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
21 марта 2024 г.
Первичное завершение (Действительный)
10 июля 2025 г.
Завершение исследования (Действительный)
25 сентября 2025 г.
Даты регистрации исследования
Первый отправленный
2 сентября 2026 г.
Впервые представлено, что соответствует критериям контроля качества
8 сентября 2026 г.
Первый опубликованный (Действительный)
14 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
14 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
8 сентября 2026 г.
Последняя проверка
1 сентября 2025 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2024-2117
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
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
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .