Impact of Cyanoacrylate Glue on PICC Line Dressing Care

June 25, 2025 updated by: Marianne Garland, Columbia University

Randomized Control Study to Evaluate Impact of the Use of Cyanoacrylate Glue on PICC Line Dressing Care in the Infant Cardiac Care Unit at Children's Hospital of New York

This study will evaluate whether applying micro drops of cyanoacrylate glue to the participant's peripherally inserted central catheter (PICC) insertion site prior to covering the area of PICC line with a transparent film dressing will make the PICC dressing last longer and prevent an occurrence of PICC line moving out of its original placement. The investigators aims to evaluate whether 1) using the cyanoacrylate glue will lengthen the time to first dressing change; and 2) participants in the experimental arm (glue used) will have fewer dressing changes per week compared to the control arm (standard care) during admission.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The neonatal population poses a unique challenge due to the small surface area of PICC sites, underdeveloped skin layer, and inability to contain the child's movements during a dressing change.

PICC line migration is the most common complication of PICC line maintenance in the neonatal intensive care unit (NICU). Previous studies have found that the PICC migration/dislodgment mostly occurs during PICC dressing changes among the neonatal population.

Recent published studies demonstrated that medical tissue adherence glue, Cyanoacrylate, significantly reduces the incidences of catheter migration and insertion site bleeding of PICC lines in all age of patients including premature infants.

The proposed study is a randomized control study with aimed data collection of 60 participants; of the 60 participants, 50 participants' data are to be used for statistical analysis and additional 10 participants to account for withdrawals.

The participants will be randomly assigned to one of two groups: one (the control group) receiving our standard PICC dressing method and the other (the study group) receiving cyanoacrylate glue at the PICC insertion sites prior to applying a standard transparent film dressing over the PICC sites.

The control group will reflect standard practice of PICC insertion and dressings using a standard transparent polyurethane film dressing, 3M TEGADERM Film.

The study group will reflect the application of a few drops of cyanoacrylate glue, SecurePortIVTM by Adhezion Biomedical® at the insertion sites prior to dressing a PICC line area with a standard transparent polyurethane film dressing.

The aim for this study is to investigate whether the application of cyanoacrylate glue at the insertion sites prior to dressing a PICC line area with a standard dressing will increase the longevity of the PICC line dressing and reduce the incidences of PICC line migration.

Study Type

Interventional

Enrollment (Actual)

32

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

  • United States
    • New York
      • New York, New York, United States, 10032
        • NewYork-Presbyterian Morgan Stanley Children's Hospital at CUIMC

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

1 day to 6 months (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients admitted to the 9 North intensive coronary care unit (ICCU) at NewYork-Presbyterian Morgan Stanley Children's Hospital greater than 35 weeks of corrected gestational age who have a PICC line placed by a NICU provider.

Exclusion Criteria:

  • Any patient with a PICC line in situ from an outside hospital.
  • Any patient with a PICC line placed by an outside department, namely the interventional radiology department.
  • Any patient with a PICC line that is silicon material catheter, such as Vygon Epicutaneo-Cava catheter because of limited accuracy of measuring a movement of the catheter migration after 25 centimeter mark due to absence of a centimeter mark on the catheter.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
This group will be received the current standard of care (SOC) dressing method for PICC lines.
Device: Standard transparent film dressing
A standard transparent polyurethane film dressing, such as 3M TEGADERM Film, for dressing the PICC line area.
Experimental: Cyanoacrylate Glue Group
This group will receive a few drops of cyanoacrylate glue on PICC line site prior to application of usual standard film dressing over the PICC line site.
Device: Standard transparent film dressing
A standard transparent polyurethane film dressing, such as 3M TEGADERM Film, for dressing the PICC line area.
Device: Cyanoacrylate glue

Adhesive to be applied on the PICC line site prior to usual standard film dressing over the site, such as SecurePortIV® Catheter Securement Adhesive by Adhezion Biomedical® Cyanoacrylate adhesive that is FDA-approved for securement of vascular access devices.

Securement method that provides microbial protection by sealing the insertion site.

Other Names:
  • SecurePortIV® Catheter Securement Adhesive

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Longevity of PICC Line Dressing
Time Frame: Up to 7 days
Duration of longevity defined as the number of days the PICC line dressing lasts from the scheduled dressing change.
Up to 7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of PICC Line Migrations
Time Frame: Until PICC line removal (approximately 12 weeks)
A PICC line migration is defined as a change in the length of catheter extruding from the insertion site - a catheter migration of more than 0.25 cm will be counted. The reported values represent the total number of PICC line migrations observed across all participants.
Until PICC line removal (approximately 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Marianne Garland, MD, Morgan Stanley Children's Hospital of NYP

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)

February 26, 2022

Primary Completion (Actual)

September 15, 2022

Study Completion (Actual)

November 16, 2022

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 18, 2022

Study Record Updates

Last Update Posted (Actual)

June 26, 2025

Last Update Submitted That Met QC Criteria

June 25, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAT5997

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to submit the study finding to professional nursing journals, such as Advanced in Neonatal Care, Journal of Neonatal Nursing, and etc

IPD Sharing Time Frame

1 to 2 years

IPD Sharing Access Criteria

To be determined by the PI

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

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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