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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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, Singapore, 529889
        • Changi General Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: The control group
The control group used the standard securement dressing
Experimental: The Treatment group
The treatment group received appropriately sized PICC sleeve cover in addition to standard device securement practices.
Other: Novel PICC Sleeve Cover
The novel PICC sleeve cover would be applied on the intervention group in addition to standard PICC securement practices.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.
From enrolment to 7 days after discharge or upon removal, whichever earlier.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.
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.
Percentage of participants with intact CHG gel or CHG gel with some swelling over the total number of participants in each arm.
From enrolment to 7 days after discharge or upon removal, whichever earlier.
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.
From enrolment to 7 days after discharge or upon removal, whichever earlier.
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
From enrolment to 7 days after discharge or upon removal, whichever earlier.
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
From enrolment to 7 days after discharge or upon removal, whichever earlier.
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
From enrolment to 7 days after discharge or upon removal, whichever earlier.
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
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changi General Hospital

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

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 21, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 10, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 8, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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