Pilot Study on the Effectiveness of Novel Peripherally Inserted Central Catheter (PICC) Securement Dressing in Preventing PICC Dislodgement

NCT07817732 | Completed DMC

• 1 other identifier: 2024-2117
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

PICC line; Pilot study; Sleeve cover

Outcome Measures

Primary Outcomes (1)

• Participant Recruitment Rate

  Number of participants recruited over the recruitment period

  16 months

Secondary Outcomes (14)

• Intervention Adherence

  From enrolment to 7 days after discharge or upon removal, whichever earlier.

• Retention of Study Participants across 3 Time-points

  From enrolment to 7 days after discharge or upon removal, whichever earlier.

• Completeness of Data Collected

  From enrolment to 7 days after discharge or upon removal, whichever earlier.

• Number of Adverse Events

  From enrolment to 7 days after discharge or upon removal, whichever earlier.

• Patient-Reported Dislodgement Risk

  From enrolment to 7 days after discharge or upon removal, whichever earlier.

Other Outcomes (8)

• Number of Dislodgement Cases

  From enrolment to 7 days after discharge or upon removal, whichever earlier.

• Dressing Condition

  From enrolment to 7 days after discharge or upon removal, whichever earlier.

• CHG Gel Condition

  From enrolment to 7 days after discharge or upon removal, whichever earlier.

Study Arms (2)

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.

Other: Novel PICC Sleeve Cover

Interventions

Novel PICC Sleeve Cover OTHER

The novel PICC sleeve cover would be applied on the intervention group in addition to standard PICC securement practices.

The Treatment group

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients receiving PICC placement for various medical conditions

You may not qualify if:

• 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

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

Related Publications (9)

• 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.

  PMID: 28256991 BACKGROUND

• 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.

  PMID: 28978332 BACKGROUND

• 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.

  PMID: 35590297 BACKGROUND

• 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.

  PMID: 28149507 BACKGROUND

• 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.

  PMID: 23361124 BACKGROUND

• 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.

  PMID: 21467014 BACKGROUND

• 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.

  PMID: 37922685 BACKGROUND

• 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.

  PMID: 32801965 BACKGROUND

• 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.

  PMID: 28619777 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pilot single-centre, parallel-group randomised controlled trial.

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 14, 2026
• Study Start: March 21, 2024
• Primary Completion: July 10, 2025
• Study Completion: September 25, 2025
• Last Updated: September 14, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)