Pilot Study on the Effectiveness of Novel Peripherally Inserted Central Catheter (PICC) Securement Dressing in Preventing PICC Dislodgement
September 8, 2026 updated by: 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
67
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Singapore, Singapore, 529889
- Changi General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: The control group
The control group used the standard securement dressing
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|
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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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participant Recruitment Rate
Time Frame: 16 months
|
Number of participants recruited over the recruitment period
|
16 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Adherence
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
Percentage of participants who were compliant to wearing the PICC sleeve cover
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Retention of Study Participants across 3 Time-points
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
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
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Completeness of Data Collected
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
Percentage of data collected over the ideal number of data to be collected
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Number of Adverse Events
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
Percentage of participants suffering from adverse events over the total number of participants
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Patient-Reported Dislodgement Risk
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
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.
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Patient-Reported Comfort Level
Time Frame: 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.
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Patient-Reported Visibility Level
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
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.
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Patient-Reported User-friendliness
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
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.
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Patient-Reported Acceptability Outcome
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
The mean of the mean scores for patient-reported dislodgement risk, comfort level, visibility level and user-friendliness.
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Staff-Reported Dislodgement Risk
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
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.
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Staff-Reported Comfort Level
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Staff-Reported Acceptability Outcome
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
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.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Dislodgement Cases
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
Number of dislodgement cases (complete/partial)
|
From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
|
Dressing Condition
Time Frame: From enrolment to 7 days after discharge or upon removal, whichever earlier.
|
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.
|
|
CHG Gel Condition
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2024
Primary Completion (Actual)
July 10, 2025
Study Completion (Actual)
September 25, 2025
Study Registration Dates
First Submitted
September 2, 2026
First Submitted That Met QC Criteria
September 8, 2026
First Posted (Actual)
September 14, 2026
Study Record Updates
Last Update Posted (Actual)
September 14, 2026
Last Update Submitted That Met QC Criteria
September 8, 2026
Last Verified
September 1, 2025
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024-2117
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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