Pilot Study on the Effectiveness of Novel Peripherally Inserted Central Catheter (PICC) Securement Dressing in Preventing PICC Dislodgement
8. september 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
67
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Singapore, Singapore, 529889
- Changi General Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Ingen inngripen: The control group
The control group used the standard securement dressing
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Participant Recruitment Rate
Tidsramme: 16 months
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Number of participants recruited over the recruitment period
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16 months
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Intervention Adherence
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Staff-Reported Visibility Level
Tidsramme: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
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.
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Staff-Reported User-friendliness
Tidsramme: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Dislodgement Cases
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
21. mars 2024
Primær fullføring (Faktiske)
10. juli 2025
Studiet fullført (Faktiske)
25. september 2025
Datoer for studieregistrering
Først innsendt
2. september 2026
Først innsendt som oppfylte QC-kriteriene
8. september 2026
Først lagt ut (Faktiske)
14. september 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
8. september 2026
Sist bekreftet
1. september 2025
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- 2024-2117
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
IPD-planbeskrivelse
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
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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