Impact of Cyanoacrylate Glue on PICC Line Dressing Care

Neonatal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05246709
• Other study ID #: AAAT5997
• Status: Completed
• Phase: N/A
• Start date: February 26, 2022
• Est. completion date: December 6, 2023

Study information

• Verified date: February 2024
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 6, 2023
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Day to 6 Months

Eligibility

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.

Related Conditions & MeSH terms

• Central Line Complication
• Infant, Newborn, Diseases
• Neonatal Disease

Intervention

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

Locations

Country	Name	City	State
United States	NewYork-Presbyterian Morgan Stanley Children's Hospital at CUIMC	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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.

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PICC line migration incidences	The incidence of PICC line migration 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 as an incidence.	Until PICC line removal (approximately 12 weeks)