Clinical Trials/NCT05246709

NCT05246709CompletedNot Applicable

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

Columbia University1 site in 1 country32 target enrollmentStarted: February 26, 2022Last updated: June 26, 2025

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Completed
Sponsor: Columbia University
Enrollment: 32
Locations: 1
Primary Endpoint: Duration of Longevity of PICC Line Dressing

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

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.

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.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Other
Masking: None

Eligibility Criteria

Ages: 1 Day to 6 Months (Child)
Sex: All
Accepts Healthy Volunteers: No

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.

Arms & Interventions

Control Group

Active Comparator

This group will be received the current standard of care (SOC) dressing method for PICC lines.

Intervention: Standard transparent film dressing (Device)

Cyanoacrylate Glue Group

Experimental

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.

Intervention: Cyanoacrylate glue (Device)

Cyanoacrylate Glue Group

Experimental

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.

Intervention: Standard transparent film dressing (Device)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Number of PICC Line Migrations(Until PICC line removal (approximately 12 weeks))

Investigators

Sponsor

Columbia University

Sponsor Class

Other

Responsible Party

Principal Investigator

Marianne Garland

Associate Professor of Pediatrics

Columbia University

Study Sites (1)

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