Impact of Cyanoacrylate Glue on PICC Line Dressing Care

NCT05246709 | Completed Results FDA Device

• 1 other identifier: AAAT5997
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Line Complication; Neonatal Disease

Keywords

PICC line dressing; cyanoacrylate glue; NICU

Outcome Measures

Primary Outcomes (1)

• Duration of Longevity of PICC Line Dressing

  Duration of longevity defined as the number of days the PICC line dressing lasts from the scheduled dressing change.

  Up to 7 days

Secondary Outcomes (1)

• Number of PICC Line Migrations

  Until PICC line removal (approximately 12 weeks)

Study Arms (2)

Control Group

ACTIVE COMPARATOR

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

Device: Standard transparent film dressing

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.

Device: Cyanoacrylate glue; Device: Standard transparent film dressing

Interventions

Cyanoacrylate glue DEVICE

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.

Also known as: SecurePortIV® Catheter Securement Adhesive

Cyanoacrylate Glue Group

Standard transparent film dressing DEVICE

A standard transparent polyurethane film dressing, such as 3M TEGADERM Film, for dressing the PICC line area.

Control Group; Cyanoacrylate Glue Group

Eligibility Criteria

• Age: 1 Day - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

NewYork-Presbyterian Morgan Stanley Children's Hospital at CUIMC

New York, New York, 10032, United States

Location

Related Publications (7)

• Acun C, Baker A, Brown LS, Iglesia KA, Sisman J. Peripherally inserted central cathether migration in neonates: Incidence, timing and risk factors. J Neonatal Perinatal Med. 2021;14(3):411-417. doi: 10.3233/NPM-200684.

  PMID: 33459671 BACKGROUND

• Bierlaire S, Danhaive O, Carkeek K, Piersigilli F. How to minimize central line-associated bloodstream infections in a neonatal intensive care unit: a quality improvement intervention based on a retrospective analysis and the adoption of an evidence-based bundle. Eur J Pediatr. 2021 Feb;180(2):449-460. doi: 10.1007/s00431-020-03844-9. Epub 2020 Oct 20.

  PMID: 33083900 BACKGROUND

• D'Andrea V, Pezza L, Barone G, Pronterà G, Pittiruti M, Vento G. Comparison study: before/after the practice change of the use of medical cyanoacrylate glue for securing ECC (epicutaneo-caval catheter). The Journal of Vascular Access. 2021; 00(0). 1-4.

  BACKGROUND

• Guido A, Zhang S, Yang C, Pook L. An innovative cyanoacrylate device developed to improve the current standard of care for intravascular catheter securement. J Vasc Access. 2020 May;21(3):293-299. doi: 10.1177/1129729819872881. Epub 2019 Sep 9.

  PMID: 31495268 BACKGROUND

• Kleidon TM, Ullman AJ, Gibson V, Chaseling B, Schoutrop J, Mihala G, Rickard CM. A Pilot Randomized Controlled Trial of Novel Dressing and Securement Techniques in 101 Pediatric Patients. J Vasc Interv Radiol. 2017 Nov;28(11):1548-1556.e1. doi: 10.1016/j.jvir.2017.07.012. Epub 2017 Sep 19.

  PMID: 28893464 BACKGROUND

• Ostroff M, Zauk A, Chowdhury S, Moureau N, Mobley C. A retrospective analysis of the clinical effectiveness of subcutaneously tunneled femoral vein cannulations at the bedside: A low risk central venous access approach in the neonatal intensive care unit. J Vasc Access. 2021 Nov;22(6):926-934. doi: 10.1177/1129729820969291. Epub 2020 Nov 5.

  PMID: 33148114 BACKGROUND

• Sharpe E, Kuhn L, Ratz D, Krein SL, Chopra V. Neonatal Peripherally Inserted Central Catheter Practices and Providers: Results From the Neonatal PICC1 Survey. Adv Neonatal Care. 2017 Jun;17(3):209-221. doi: 10.1097/ANC.0000000000000376.

  PMID: 28045704 BACKGROUND

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: Seon Mi Jeong
• Organization: Columbia University

smj9007@nyp.org

646-317-5238

Study Officials

• Marianne Garland, MD

  Morgan Stanley Children's Hospital of NYP

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Model Details: Randomized control study

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 18, 2022
• Study Start: February 26, 2022
• Primary Completion: September 15, 2022
• Study Completion: November 16, 2022
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: 1 to 2 years
• Access Criteria: To be determined by the PI

Locations

US (1)