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Completed

NCT Number: NCT07817732

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

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.

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Key information

Conditions

Patient With PICC Lines PICC

Age range

21 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changi General Hospital

Singapore, 529889

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novel PICC Sleeve Cover

Other

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

Primary outcomes

  1. Participant Recruitment Rate

    Time frame: 16 months

    Number of participants recruited over the recruitment period

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Other outcomes

  1. Number of Dislodgement Cases

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

    Number of dislodgement cases (complete/partial)

  2. 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.

  3. CHG Gel Condition

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

    Percentage of participants with intact CHG gel or CHG gel with some swelling over the total number of participants in each arm.

  4. External Length

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

    Percentage of participants with the same or minimally changed (< 2cm) external length of PICC over the total number of participants in each arm.

  5. Patency of PICC Lumens

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

    Percentage of participants whose PICC are still patent with or without backflow over the total number of participants in each arm

  6. Insertion Site

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

    Percentage of participants without any redness, slough or necrotic tissue at the insertion site over the total number of participants in each arm

  7. Discharge from PICC insertion site

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

    Percentage of participants with no discharge from the PICC insertion site over the total number of participants in each arm

  8. Surrounding Skin around PICC Insertion Site

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

    Percentage of participants with nil redness of surrounding skin around the PICC insertion site over the total number of participants in each arm

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

Changi General Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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