Patient With PICC LinesNCT07817732
Pilot Study on the Effectiveness of Novel Peripherally Inserted Central Catheter (PICC) Securement Dressing in Preventing PICC Dislodgement
A study testing Novel PICC Sleeve Cover in people with Patient With PICC Lines and PICC, run by Changi General Hospital at 1 site in Singapore.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Patient With PICC Lines, PICC
- What is being tested?
- Novel PICC Sleeve Cover
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteSingapore
- Study dates
- 21 Mar 2024to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients receiving PICC placement for various medical conditions
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Patient With PICC Lines, PICC
- Being tested
- Novel PICC Sleeve Cover
- Keywords
- PICC line, Pilot study, Sleeve cover
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel PICC Sleeve CoverOther
The novel PICC sleeve cover would be applied on the intervention group in addition to standard PICC securement practices.
| Study group | Role | What they receive |
|---|---|---|
| The control group | No intervention | The control group used the standard securement dressing |
| The Treatment group | Experimental | The treatment group received appropriately sized PICC sleeve cover in addition to standard device securement practices. Receives: Other: Novel PICC Sleeve Cover |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant Recruitment Rate
Number of participants recruited over the recruitment period
Measured: 16 months
Secondary outcomes (14)
Intervention Adherence
Percentage of participants who were compliant to wearing the PICC sleeve cover
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Retention of Study Participants across 3 Time-points
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
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Completeness of Data Collected
Percentage of data collected over the ideal number of data to be collected
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Number of Adverse Events
Percentage of participants suffering from adverse events over the total number of participants
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Patient-Reported Dislodgement Risk
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.
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Patient-Reported Comfort Level
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.
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Patient-Reported Visibility Level
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.
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Patient-Reported User-friendliness
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.
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Patient-Reported Acceptability Outcome
The mean of the mean scores for patient-reported dislodgement risk, comfort level, visibility level and user-friendliness.
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Staff-Reported Dislodgement Risk
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.
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Staff-Reported Comfort Level
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.
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Staff-Reported Visibility Level
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.
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Staff-Reported User-friendliness
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.
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Staff-Reported Acceptability Outcome
The mean of the mean scores for staff-reported dislodgement risk, comfort level, visibility level and user-friendliness.
Measured: From enrolment to 7 days after discharge or upon removal, whichever earlier.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start21 Mar 2024
- Primary completion10 Jul 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Patient With PICC LinesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot single-centre, parallel-group randomised controlled trial.
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817732
- Sponsor's protocol ID
- 2024-2117
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 28256991Chan 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.
PubMed 28978332Dong 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.
PubMed 35590297Grau 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.
PubMed 28149507Moureau 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.
PubMed 23361124O'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.
PubMed 21467014Yu 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.
PubMed 37922685Xu 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.
PubMed 32801965Rickard 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.
PubMed 28619777
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Effectiveness of Novel Peripherally Inserted Central Catheter (PICC) Securement Dressing in Preventing PICC Dislodgement
- ClinicalTrials.gov ID
- NCT07817732
- Acronym / sponsor ID
- 2024-2117
- Conditions
- Patient With PICC Lines, PICC
- Keywords
- PICC line, Pilot study, Sleeve cover
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 10 Jul 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot single-centre, parallel-group randomised controlled trial.
| Arm | Type | Receives |
|---|---|---|
| The control group | No intervention | –The control group used the standard securement dressing |
| The Treatment group | Experimental | Other: Novel PICC Sleeve CoverThe treatment group received appropriately sized PICC sleeve cover in addition to standard device securement practices. |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients receiving PICC placement for various medical conditions
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel PICC Sleeve CoverThe novel PICC sleeve cover would be applied on the intervention group in addition to standard PICC securement practices. | Other | The Treatment group |
Primary outcome
Participant Recruitment Rate
Time frame: 16 months
Number of participants recruited over the recruitment period
14 secondary outcomes
Intervention Adherence
Time frame: 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.
Completeness of Data Collected
Time frame: 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.
Patient-Reported Dislodgement Risk
Time frame: 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.
Patient-Reported Visibility Level
Time frame: 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.
Patient-Reported Acceptability Outcome
Time frame: 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.
Staff-Reported Comfort Level
Time frame: 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.
Staff-Reported User-friendliness
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Background: PubMed 28256991Karpanen 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.
- Background: PubMed 28978332Chan 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.
- Background: PubMed 35590297Dong 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.
- Background: PubMed 28149507Grau 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.
- Background: PubMed 23361124Moureau 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.
- Background: PubMed 21467014O'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.
- Background: PubMed 37922685Yu 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.
- Background: PubMed 32801965Xu 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.
- Background: PubMed 28619777Rickard 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel PICC Sleeve Cover in people with Patient With PICC Lines and PICC, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participant Recruitment Rate (time frame: 16 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07817732, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.