Pilot Study on the Effectiveness of Novel Peripherally Inserted Central Catheter (PICC) Securement Dressing in Preventing PICC Dislodgement
8 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
67
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Singapore, Cingapura, 529889
- Changi General Hospital
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Sem intervenção: The control group
The control group used the standard securement dressing
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Experimental: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Participant Recruitment Rate
Prazo: 16 months
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Number of participants recruited over the recruitment period
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16 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intervention Adherence
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Dislodgement Cases
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
21 de março de 2024
Conclusão Primária (Real)
10 de julho de 2025
Conclusão do estudo (Real)
25 de setembro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
2 de setembro de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
8 de setembro de 2026
Primeira postagem (Real)
14 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
14 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
8 de setembro de 2026
Última verificação
1 de setembro de 2025
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 2024-2117
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Descrição do plano 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
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .